Page last updated: 2024-11-06

clavulanic acid

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Description

Clavulanic Acid: A beta-lactam antibiotic produced by the actinobacterium Streptomyces clavuligerus. It is a suicide inhibitor of bacterial beta-lactamase enzymes. Administered alone, it has only weak antibacterial activity against most organisms, but given in combination with other beta-lactam antibiotics it prevents antibiotic inactivation by microbial lactamase. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

clavulanate : The conjugate base of clavulanic acid. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

clavulanic acid : Antibiotic isolated from Streptomyces clavuligerus. It acts as a suicide inhibitor of bacterial beta-lactamase enzymes. [Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Cross-References

ID SourceID
PubMed CID5280980
CHEMBL ID777
CHEBI ID48947
SCHEMBL ID6093
SCHEMBL ID34260
MeSH IDM0029416

Synonyms (71)

Synonym
brn 0787059
acido clavulanico [inn-spanish]
3008-b
acide clavulanique [inn-french]
brl-14151
brl 14151
acidum clavulanicum [inn-latin]
4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, (2r-(2alpha,3z,5alpha))
(z)-(2r,5r)-3-(2-hydroxyethyliden)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptan-2-carbonsaeure
clavulansaeure [inn]
4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, (2r-(2-alpha,3z,5-alpha))-
einecs 261-069-2
clavulox (tn)
clavulanic acid (inn)
D07711
BSPBIO_002430
clavulonic acid
acide clavulanique
mm 14151
acido clavulanico
antibiotic mm 14151
CHEBI:48947 ,
acidum clavulanicum
clavulansaeure
clavulanic acid
C06662
clavulanate
(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid
clavulinic acid
(z)-(2r,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid
DB00766
rx-10100
serdaxin
CHEMBL777 ,
bdbm50021959
NCGC00188985-01
brl14151
clavulanate lithium
AKOS016009164
clavulanic acid [inn:ban]
unii-23521w1s24
23521w1s24 ,
EPITOPE ID:117130
(2r,3z,5r)-3-(2-hydroxyethylidene)-7-oxo-4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid
clavulanic acid [mi]
clavulanic acid [inn]
clavulanic acid [who-dd]
4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, (2r-(2.alpha.,3z,5.alpha.))-
clavulanic acid [mart.]
clavulanate [vandf]
SCHEMBL6093
SCHEMBL34260
4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, (2r,3z,5r)-
DTXSID2022830 ,
gtpl11128
SBI-0206779.P001
clavulox
4-oxa-1-azabicyclo[3.2.0]heptane-2-carboxylic acid,3-(2-hydroxyethylidene)-7-oxo-,(2r,3z,5r)-
Q415709
1365254-41-6
MS-23077
HY-A0256
CS-0017600
clavulanateacid
EN300-7431555
66428-09-9
clavulansaure
dtxcid702830
acidum clavulanicum (inn-latin)
4-oxa-1-azabicyclo(3.2.0)heptane-2-carboxylic acid, 3-(2-hydroxyethylidene)-7-oxo-, (2r-(2alpha,3z,5alpha))-
clavulanic acid (mart.)

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Adverse reactions to the study drug were minimal; eosinophilia, unaccompanied by other allergic phenomena, and oral candidiasis were most frequent."( Clinical trial of the efficacy and safety of ticarcillin and clavulanic acid.
Bibler, M; Bode, R; Bullock, WE; Douce, R; Hamilton, B; Roselle, GA; Staneck, JL; Sullivan, R, 1985
)
0.27
" Adverse reactions (all reversible) were reported in 11 (61 percent) patients, the most frequent of which was phlebitis."( Safety and effectiveness of ticarcillin plus clavulanic acid in the treatment of community-acquired acute pyelonephritis in adult women.
Aldridge, KE; Derks, FW; Marier, RL; Martin, DH; Sanders, CV, 1985
)
0.27
" Adverse drug-related reactions required discontinuation of treatment in two patients, although other minor abnormal laboratory findings were common."( Safety and efficacy of ticarcillin plus clavulanic acid in the treatment of infections of soft tissue, bone, and joint.
Finegold, SM; George, WL; Helsel, CL; Johnson, CC; Mulligan, ME; Reinhardt, JF; Terpenning, MS; Wallace, SL, 1985
)
0.27
" All 43 patients were monitored for adverse reactions by both clinical observation and laboratory tests."( Safety and effectiveness of ticarcillin plus clavulanate potassium in treatment of lower respiratory tract infections.
Mostow, SR; O'Brien, RF, 1985
)
0.27
" The incidence of adverse reactions was similar in both groups."( Efficacy and safety of piperacillin/tazobactam in skin and soft tissue infections.
File, TM; Tan, JS, 1994
)
0.29
" We conclude that clarithromycin is a safe and effective antimicrobial agent for the treatment of acute otitis media in children."( Comparative study of the safety and efficacy of clarithromycin and amoxicillin-clavulanate in the treatment of acute otitis media in children.
Aronoff, S; Arrieta, A; Aspin, MM; Hoberman, A; Lang, DJ; McCarty, J; McLinn, SE, 1994
)
0.29
" Gastrointestinal adverse events were the most commonly reported in both groups."( Comparative safety and efficacy of clarithromycin and amoxicillin/clavulanate in the treatment of acute otitis media in children.
McCarty, JM; Phillips, A; Wiisanen, R, 1993
)
0.29
" We conclude that OM-85-BV is safe at pediatric ages, as well as accelerates the cure and improvement of subacute sinusitis while it lowers the incidence of respiratory infections."( [Safety and efficacy of OM-85-BV plus amoxicillin/clavulanate in the treatment of subacute sinusitis and the prevention of recurrent infections in children].
Alvarez, A; Berber, A; De la Torre, C; Faure, A; Gómez Barreto, D,
)
0.13
"5%) and also the incidence of adverse events which occurred in 24/163 (14."( Comparison of the efficacy and safety of a short course of ceftibuten with that of amoxycillin/clavulanate in the treatment of acute exacerbations of chronic bronchitis.
Guest, N; Langan, CE, 1998
)
0.3
" Comparable incidences of adverse events, mainly mild or moderate in intensity, were experienced in each treatment group."( Treatment of complicated intra-abdominal infections: comparison of the tolerability and safety of intravenous/oral trovafloxacin versus intravenous imipenem/cilastatin switching to oral amoxycillin/clavulanic acid.
Luke, DR; Peterson, J,
)
0.13
" In spite of statements about the safe use of drugs in lactation by the American Academy of Pediatrics, medical professionals remain confused regarding the management of drug therapy in nursing mothers, and this can lead to suboptimal prescribing and poor compliance."( The safety of amoxicillin/clavulanic acid and cefuroxime during lactation.
Benyamini, L; Berkovitch, M; Bortnik, O; Braunstein, R; Bulkowstein, M; Merlob, P; Stahl, B; Zimmerman, D, 2005
)
0.33
" It is well documented that the clavulanate component may cause adverse reactions by itself, thus exposing patients to further, and sometimes undue, risks."( Amoxicillin and amoxicillin plus clavulanate: a safety review.
Caputi, AP; De Sarro, A; Polimeni, G; Salvo, F, 2009
)
0.35
" Adverse event rates were comparable between treatment groups."( Efficacy and safety of sequential intravenous/oral moxifloxacin vs intravenous/oral amoxicillin/clavulanate for complicated skin and skin structure infections.
Amábile-Cuevas, CF; Arvis, P; Bogner, JR; Cruz-Alcázar, J; Hernández-Oliva, G; Reimnitz, P; Vick-Fragoso, R, 2009
)
0.35
"Antibiotics for suspected acute appendicitis are safe and effective and may avoid unnecessary appendectomy, reducing operation rate, surgical risks, and overall costs."( The NOTA Study (Non Operative Treatment for Acute Appendicitis): prospective study on the efficacy and safety of antibiotics (amoxicillin and clavulanic acid) for treating patients with right lower quadrant abdominal pain and long-term follow-up of conser
Ansaloni, L; Biscardi, A; Catena, F; Coccolini, F; Di Saverio, S; Giorgini, E; Pisano, M; Sartelli, M; Sibilio, A; Smerieri, N; Tugnoli, G; Villani, S, 2014
)
0.4
" Azithromycin was not associated with excess serious adverse events (SAEs)."( Efficacy and safety of World Health Organization group 5 drugs for multidrug-resistant tuberculosis treatment.
Butler-Laporte, G; Menzies, D; Winters, N, 2015
)
0.42
" Only six cases reported adverse events attributable to meropenem/clavulanate (four of them then restarting treatment)."( Effectiveness and safety of meropenem/clavulanate-containing regimens in the treatment of MDR- and XDR-TB.
Abdo Arbex, M; Akkerman, OW; Alarcon Arrascue, E; Alarcon Guizado, V; Aleska, A; Alffenaar, JW; Avchinko, V; Bonini, EH; Caminero, JA; Centis, R; Chong Marín, FA; Collahuazo López, L; D'Ambrosio, L; De Lorenzo, S; de Vries, G; Dore, S; Gaga, M; Gualano, G; Kunst, H; Matteelli, A; Migliori, GB; Moschos, C; Palmieri, F; Papavasileiou, A; Payen, MC; Roby Arias, AJ; Scardigli, A; Skrahina, A; Solovic, I; Sotgiu, G; Spanevello, A; Sulis, G; Tadolini, M; Tiberi, S; Vargas Vasquez, D; Viggiani, P; White, V; Zumla, A, 2016
)
0.43
" While no adverse events were reported for IC, 2 minor side effects, only, were attributed to linezolid (17%); in both cases the drug was re-started without further problems."( Effectiveness and safety of imipenem/clavulanate and linezolid to treat multidrug and extensively drug-resistant tuberculosis at a referral hospital in Brazil.
Arbex, MA; Bonini, EH; Centis, R; D'Ambrosio, L; Kawakame Pirolla, G; Migliori, GB,
)
0.13
" When using amoxicillin/clavulanate in the elderly, the risk of adverse drug reaction may be greater."( Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects.
Choi, Y; Chung, JY; Jang, K; Lee, SW; Yoon, SH, 2020
)
0.56
" Safety assessments including clinical laboratory tests, physical examination, vital signs, and adverse event (AE) monitoring were performed throughout the study."( Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects.
Choi, Y; Chung, JY; Jang, K; Lee, SW; Yoon, SH, 2020
)
0.56
"5 mg was safe and well-tolerated, the systemic exposure of amoxicillin and clavulanate was higher in elderly subjects than in younger subjects."( Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects.
Choi, Y; Chung, JY; Jang, K; Lee, SW; Yoon, SH, 2020
)
0.56
"An early intravenous-to-oral antibiotic switch with amoxicillin-clavulanic acid is non-inferior to a full course of intravenous antibiotics in neonates with probable bacterial infection and is not associated with an increased incidence of adverse events."( Efficacy and safety of switching from intravenous to oral antibiotics (amoxicillin-clavulanic acid) versus a full course of intravenous antibiotics in neonates with probable bacterial infection (RAIN): a multicentre, randomised, open-label, non-inferiorit
Allegaert, K; Baartmans, MGA; den Butter, PCP; Driessen, GJA; Eijkemans, M; Hartwig, NG; Heidema, J; Keij, FM; Kenter, S; Kornelisse, RF; Meijssen, CB; Norbruis, OF; Qi, H; Reiss, IKM; Stam-Stigter, GM; Tramper-Stranders, GA; van Beek, RHT; van Dalen-Vink, I; van den Berg, MM; van der Meer-Kappelle, LH; van der Sluijs-Bens, J; van Driel, A; van Rooij, LGM; van Rossem, MC; von Lindern, JS, 2022
)
0.72

Pharmacokinetics

The pharmacokinetic properties of amoxicillin and clavulanic acid when used alone or in combination are extensively reviewed and discussed in this article. To date, there has been no report studying the pharmacokinetics characteristics of am Toxicillin and Clavulanic acid in man.

ExcerptReferenceRelevance
" The elimination half-life of clavulanate in some individuals was much shorter because of higher plasma clearance."( Pharmacokinetics of intravenous amoxycillin and potassium clavulanate in seriously ill children.
Barnes, ND; Horton, R; Jones, AE; Tasker, TC, 1990
)
0.28
" The pharmacokinetic parameters of the two components are similar, both being eliminated primarily by renal excretion."( The pharmacokinetics of sultamicillin.
Bruckner, G; Hampel, B; Koeppe, P; Lode, H, 1989
)
0.28
" The mean values of total serum clearance, mean residence time, volume of distribution at steady state, and terminal half-life for amoxycillin on the non-dialysis day were 14."( Pharmacokinetics of amoxycillin and clavulanic acid in haemodialysis patients following intravenous administration of Augmentin.
Boon, R; Davies, BE; Descoeudres, CE; Horton, R; Reubi, FC, 1988
)
0.27
" This is supported by comparison of certain pharmacokinetic parameters for TICAR and CLA."( Serum levels and pharmacokinetics of ticarcillin and clavulanic acid in dog following parenteral administration of Timentin.
Garg, RC; Keefe, TJ; Vig, MM, 1987
)
0.27
" Plasma data after intravenous administration were subjected to pharmacokinetic analysis using a two-compartment open model."( Bioavailability and pharmacokinetics of clavulanic acid in healthy subjects.
Clarke, JG; Coates, PE; Davies, BE; Sutton, JA; Thawley, AR, 1985
)
0.27
" Model-dependent and noncompartmental pharmacokinetic parameters were congruous."( Ticarcillin/clavulanic acid pharmacokinetics in children and young adults with cystic fibrosis.
Brown, AL; Jacobs, RF; Kearns, GL; Kluza, RB; Trang, JM; Underwood, FL; Warren, RH, 1985
)
0.27
" Clavulanic acid is adequately absorbed after oral administration and its basic pharmacokinetic characteristics are similar to those of amoxycillin."( Amoxycillin/clavulanic acid: a review of its antibacterial activity, pharmacokinetics and therapeutic use.
Avery, GS; Brogden, RN; Carmine, A; Heel, RC; Morley, PA; Speight, TM, 1981
)
0.26
"The pharmacokinetic behaviour of an amoxicillin/clavulanic acid combination was studied after intravenous administration of single doses (20 mg/kg per kg body weight) to five sheep and six goats."( Comparative pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous administration to sheep and goats.
Baggot, JD; Carceles, CM; Escudero, E, 1995
)
0.29
" After oral administration of both drugs their pharmacokinetic behaviour was best described by an open one-compartment model with first-order absorption."( Pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous and oral administration in goats.
Carceles, CM; Carli, S; Escudero, E; Serrano, JM; Vicente, MS, 1995
)
0.29
"The pharmacokinetic behaviour of an amoxicillin/clavulanic acid combination (25 mg kg-1), and both drugs alone (amoxicillin 20 mg kg-1), clavulanic acid 5 mg kg-1), was studied after intravenous (i."( Pharmacokinetics of amoxicillin/clavulanic acid combination and of both drugs alone after intravenous administration to goats.
Carceles, CM; Escudero, E; Vicente, S, 1996
)
0.29
" After intramuscular administration both drugs had a significantly longer half-life (P<0."( Pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous and intramuscular administration to pigeons.
Carceles, CM; Escudero, E; Vicente, MS,
)
0.13
" The objective of this article is to evaluate the pharmacokinetic properties of three commercially available beta-lactamase inhibitors."( Pharmacokinetic properties of beta-lactamase inhibitors.
de la Pena, A; Derendorf, H, 1999
)
0.3
"Based on published articles in the literature, the pharmacokinetic properties of the beta-lactamase inhibitors clavulanic acid, sulbactam and tazobactam are reviewed and compared."( Pharmacokinetic properties of beta-lactamase inhibitors.
de la Pena, A; Derendorf, H, 1999
)
0.3
"When choosing combinations of a beta-lactam antibiotic with a beta-lactamase inhibitor, it is important to make sure that the pharmacokinetic properties of drug and inhibitor are similar and remain similar under changing pathophysiological conditions."( Pharmacokinetic properties of beta-lactamase inhibitors.
de la Pena, A; Derendorf, H, 1999
)
0.3
"A randomized, open, single-dose, sinus tissue pharmacokinetic study with oral amoxicillin/clavulanic acid."( Sinus tissue pharmacokinetics after oral administration of amoxicillin/clavulanic acid.
Dinis, PB; Gomes, A; Martins, ML; Monteiro, MC; Silva, N, 2000
)
0.31
"Although the in vitro activity of the tested drugs evaluated by time-kill curves seemed comparable, some pharmacokinetic and pharmacodynamic characteristics of TGA contribute to improving the resolution of the infective process."( Comparative effect of thiamphenicol glycinate, thiamphenicol glycinate N-acetylcysteinate, amoxicillin plus clavulanic acid, ceftriaxone and clarithromycin on pulmonary clearance of Haemophilus influenzae in an animal model.
De Vecchi, E; Drago, L; Fassina, MC; Gismondo, MR; Lombardi, A; Mombelli, B,
)
0.13
"The enhanced pharmacokinetic profile of amoxicillin/clavulanate seen in this study suggests that this formulation is likely to be highly effective for the oral treatment of infections caused by bacteria--including beta-lactamase-producing organisms--and strains with amoxicillin MICs < or = 4 microg/mL."( The clinical pharmacokinetics of a new pharmacokinetically enhanced formulation of amoxicillin/clavulanate.
Allen, A; Bird, N; Davy, M; Dewit, O; Kaye, CM; McDonagh, M; Perry, S; Storm, K, 2001
)
0.31
"To compare the pharmacodynamic effects of a pharmacokinetically enhanced formulation of amoxicillin 2000 mg twice daily, with amoxicillin 875 mg twice daily, 875 mg three times daily and 500 mg three times daily against Streptococcus pneumoniae with different susceptibility to amoxicillin in an in vitro kinetic model."( Pharmacodynamic studies of amoxicillin against Streptococcus pneumoniae: comparison of a new pharmacokinetically enhanced formulation (2000 mg twice daily) with standard dosage regimens.
Cars, O; Löwdin, E; Odenholt, I, 2004
)
0.32
"The pharmacokinetic properties of amoxicillin and clavulanic acid when used alone or in combination are extensively reviewed and discussed in this article."( New formulations of amoxicillin/clavulanic acid: a pharmacokinetic and pharmacodynamic review.
Sánchez Navarro, A, 2005
)
0.33
"We conducted a prospective pharmacokinetic study of oral co-amoxiclav in patients with melioidosis to determine the optimal dosage and dosing interval in this potentially fatal infection."( Pharmacokinetic and pharmacodynamic assessment of co-amoxiclav in the treatment of melioidosis.
Chaowagul, W; Chierakul, W; Dance, DA; Day, NP; Lindegardh, N; Maharjan, B; Peacock, SJ; Pongtavornpinyo, W; Short, JM; Singtoroj, T; Teparrukkul, P; Wangboonskul, J; White, NJ; Wuthiekanun, V, 2006
)
0.33
" azithromycin once daily pharmacodynamic simulation was performed against 10(8) cfu/ml of four Streptococcus pneumoniae strains (exhibiting higher amoxicillin than penicillin MIC) and four Haemophilus influenzae strains: beta-lactamase producing, BLNAR (beta-lactamase-negative ampicillin-resistant) and BLPACR (beta-lactamase-positive amoxicillin/clavulanate-resistant)."( Levofloxacin vs. azithromycin pharmacodynamic activity against S. pneumoniae and H. influenzae with decreased susceptibility to amoxicillin/clavulanic acid.
Aguilar, L; Alou, L; Echeverría, O; Giménez, MJ; González, N; Martín, JE; Prieto, J; Sevillano, D; Torrico, M; Valdés, L, 2007
)
0.34
" pharmacokinetic data on 670 drugs representing, to our knowledge, the largest publicly available set of human clinical pharmacokinetic data."( Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
Lombardo, F; Obach, RS; Waters, NJ, 2008
)
0.35
" We present the first evaluation of the bone penetration of a beta-lactam by population pharmacokinetics and pharmacodynamic profiling via Monte Carlo simulations."( Bone penetration of amoxicillin and clavulanic acid evaluated by population pharmacokinetics and Monte Carlo simulation.
Bulitta, JB; Gusinde, J; Hennig, FF; Holzgrabe, U; Kinzig, M; Landersdorfer, CB; Sörgel, F, 2009
)
0.35
" To date, there has been no report studying the pharmacokinetic characteristics of amoxicillin and clavulanic acid in man."( Pharmacokinetics study of amoxycillin and clavulanic acid (8:1)--a new combination in healthy Chinese adult male volunteers using the LC-MS/MS method.
Jia, Z; Men, X; Wang, R; Wang, Y; Xie, H; Xu, L; Zhang, J; Zhang, Q, 2013
)
0.39
" Pharmacokinetic parameters of tablet (CDPX 200mg, CA 125mg) were evaluated."( Simultaneous quantification of cefpodoxime proxetil and clavulanic acid in human plasma by LC-MS using solid phase extraction with application to pharmacokinetic studies.
Dubala, A; George, R; Nagarajan, JS; Vimal, CS, 2013
)
0.39
" However, the time required to reach maximum concentration at steady state and the elimination half-life were similar in the two age groups."( Multiple-dose pharmacokinetics and safety of amoxicillin/clavulanate in healthy elderly subjects.
Choi, Y; Chung, JY; Jang, K; Lee, SW; Yoon, SH, 2020
)
0.56
"Prospective, single-centre, open-label, non-randomized, crossover pharmacokinetic trial having enrolled obese otherwise healthy adult subjects."( Population pharmacokinetics and dosing simulations of amoxicillin in obese adults receiving co-amoxiclav.
Burdet, C; Carette, C; Crémieux, AC; Czernichow, S; Duval, X; El-Helali, N; Hammas, K; Massias, L; Mellon, G; Mentré, F, 2020
)
0.56
" Amoxicillin Cmax after oral administration significantly reduced with weight (P = 0."( Population pharmacokinetics and dosing simulations of amoxicillin in obese adults receiving co-amoxiclav.
Burdet, C; Carette, C; Crémieux, AC; Czernichow, S; Duval, X; El-Helali, N; Hammas, K; Massias, L; Mellon, G; Mentré, F, 2020
)
0.56
" Here, we propose to estimate the in vivo functional ontogeny of transporters using a combined population pharmacokinetic (popPK) and physiology-based pharmacokinetic (PBPK) modeling approach called popPBPK."( Estimation of Ontogeny Functions for Renal Transporters Using a Combined Population Pharmacokinetic and Physiology-Based Pharmacokinetic Approach: Application to OAT1,3.
Allegaert, K; Cristea, S; De Cock, P; de Jaeger, A; De Paepe, P; Knibbe, CAJ; Krekels, EHJ, 2021
)
0.62
" We included all published studies reporting pharmacokinetic data on clavulanic acid in neonates and children 0-18 years of age."( Pharmacokinetics of Clavulanic Acid in the Pediatric Population: A Systematic Literature Review.
Allegaert, K; Keij, FM; Koch, BCP; Kornelisse, RF; Muller, AE; Reiss, IKM; Tramper-Stranders, GA, 2022
)
0.72
" Model-based pharmacokinetic studies that address both maturational and disease-specific changes in the pediatric population are therefore needed."( Pharmacokinetics of Clavulanic Acid in the Pediatric Population: A Systematic Literature Review.
Allegaert, K; Keij, FM; Koch, BCP; Kornelisse, RF; Muller, AE; Reiss, IKM; Tramper-Stranders, GA, 2022
)
0.72
" WinNonlin software was used to evaluate the pharmacokinetic parameters (noncompartmental model)."( Pharmacokinetics of Amoxicillin and Clavulanate Potassium for Suspension (200 mg/28.5 mg) in Healthy Subjects: Sample Add Stabilizer Study and Food Effects.
Qin, F; Xu, PS; Xu, SM; Zhang, YD, 2022
)
0.72

Compound-Compound Interactions

The activity of six cephalosporins, six penicillins and one monobactam combined with BRL 42715, clavulanic acid, sulbactam or tazobactsam at 0.5 mg/l bound to PBP 2 by greater than 50% in all strains. When combined with cefpirome, the density of P BP 2a was also reduced but not completely abolished.

ExcerptReferenceRelevance
"The activity of clavulanic acid alone and in combination with penicillin, amoxycillin, and carbenicillin was studied."( In vitro study of clavulanic acid in combination with penicillin, amoxycillin, and carbenicillin.
Andrews, JM; Bedford, KA; Wise, R, 1978
)
0.26
" Clavulanic acid at a concentration of 10 mg/l bound to PBP 2 by greater than 50% in all strains, and when combined with cefpirome, the density of PBP 2a was also reduced but not completely abolished."( Activity of cefpirome combined with beta-lactamase inhibitors and affinity for the penicillin-binding proteins of methicillin-resistant Staphylococcus aureus.
Griggs, DJ; Piddock, LJ; Traynor, EA, 1992
)
0.28
"Amoxicillin, a beta-lactam antibiotic, was tested for its effect in combination with clavulanic acid, a beta-lactamase inhibitor, against 9 species of bacteria isolated from clinical specimens."( Antibacterial activities of amoxicillin alone and in combination with clavulanic acid correlated with beta-lactamase production.
Chang, SC; Hsieh, WC; Hsu, LY; Luh, KT, 1991
)
0.28
"The beta-lactamase inhibitor, clavulanic acid, was combined with amoxicillin and with ticarcillin for in vitro studies with 586 staphylococci: 97 stock cultures of oxacillin-resistant strains recovered before 1982, and 489 blood or wound isolates collected from 40 separate medical centers during 1987-1988 (300 were oxacillin resistant)."( Antistaphylococcal activity of amoxicillin and ticarcillin when combined with clavulanic acid. Evaluation of oxacillin-resistant and oxacillin-susceptible isolates.
Barry, AL,
)
0.13
"We evaluated cefotaxime (CTX) alone and in combination with its metabolite, desacetylcefotaxime (dCTX) against strains of Staphylococcus aureus that produce the four recognized variants of staphylococcal beta-lactamase and a beta-lactamase-producing isolate characterized by the expression of borderline resistance to methicillin."( Evaluation of cefotaxime alone and in combination with desacetylcefotaxime against strains of Staphylococcus aureus that produce variants of staphylococcal beta-lactamase.
Eades, SC; Kernodle, DS; Stratton, CW; Weeks, LS,
)
0.13
"The in vitro synergistic activities of the beta-lactamase inhibitors YTR 830, clavulanate, and sulbactam, combined with ampicillin, ticarcillin, mezlocillin, azlocillin, piperacillin, and apalcillin, were determined against 34 strains of members of the Enterobacteriaceae family, Pseudomonas aeruginosa, Aeromonas hydrophila, and Haemophilus influenzae with characterized plasmid or chromosomal beta-lactamases or both."( Comparative activities of the beta-lactamase inhibitors YTR 830, clavulanate, and sulbactam combined with ampicillin and broad-spectrum penicillins against defined beta-lactamase-producing aerobic gram-negative bacilli.
Aronoff, SC; Jacobs, MR; Johenning, S; Shlaes, DM; Yamabe, S, 1986
)
0.27
"The in-vitro synergistic activity of YTR 830, a new beta-lactamase inhibitor, combined with four extended-spectrum penicillins (ticarcillin, piperacillin, mezlocillin and apalcillin) against ticarcillin-resistant clinical isolates of Gram-negative enteric bacilli was compared with that of clavulanate and sulbactam."( Comparative activities of the beta-lactamase inhibitors YTR 830, clavulanate and sulbactam combined with extended-spectrum penicillins against ticarcillin-resistant Enterobacteriaceae and pseudomonads.
Aronoff, SC; Jacobs, MR; Johenning, S; Yamabe, S, 1986
)
0.27
"The in vitro activities of the beta-lactamase inhibitors YTR 830, clavulanate, and sulbactam combined with six beta-lactams against 88 beta-lactamase-producing anaerobes were determined."( Comparative activity of beta-lactamase inhibitors YTR 830, clavulanate, and sulbactam combined with beta-lactams against beta-lactamase-producing anaerobes.
Appelbaum, PC; Jacobs, MR; Spangler, SK; Yamabe, S, 1986
)
0.27
"The in-vitro activity of a beta-lactamase inhibitor (clavulanic acid, sulbactam, BL-P2013 or BL-P2090) in combination with ampicillin against 13 isolates of Mycobacterium tuberculosis was determined by broth dilution."( Comparison of four beta-lactamase inhibitors in combination with ampicillin against Mycobacterium tuberculosis.
Cynamon, MH; Sorg, TB, 1987
)
0.27
"The antibacterial activity of ampicillin against Enterobacteriaceae strongly increased when combined with 6 beta-bromopenicillanic acid (BPA) or clavulanic acid (CA)."( In vitro activity of ampicillin alone and in combination with different concentrations of 6 beta-bromopenicillanic acid, clavulanic acid and mecillinam.
Houben, AW; Stobberingh, EE; van Boven, CP, 1987
)
0.27
" chelonei) to ticarcillin in combination with calvulanic acid (CA) was studied by the agar dilution method."( In vitro susceptibility of Mycobacterium tuberculosis, Mycobacterium africanum, Mycobacterium bovis, Mycobacterium avium, Mycobacterium fortuitum, and Mycobacterium chelonae to ticarcillin in combination with clavulanic acid.
Benavente, MC; Casal, MJ; Luna, MD; Rodriguez, FC, 1987
)
0.27
" Four different groups of animals with appropriate controls were treated with penicillin or ticarcillin alone or in combination with CA."( Activity of penicillin or ticarcillin in combination with clavulanic acid in the treatment of experimental intra-abdominal abscess.
Bansal, MB; Prabahala, R; Thadepalli, H, 1986
)
0.27
"Twelve strains of Nocardia asteroides were studied for their susceptibility to 21 beta-lactam antibiotics, alone or in combination with clavulanic acid, sulbactam, or BLP 2013, and for their content of beta-lactamase."( In-vitro susceptibility of Nocardia asteroides to 21 beta-lactam antibiotics, in combination with three beta-lactamase inhibitors, and its relationship to the beta-lactamase content.
Acar, JF; Gutmann, L; Kitzis, MD, 1985
)
0.27
"To study the absorption and disposition of clavulanic acid, ten healthy men received one intravenous and one oral dose of 125 mg clavulanic acid in combination with amoxycillin."( Pharmacokinetics of clavulanic acid, given in combination with amoxycillin, in volunteers.
Fellner, H; Hedström, SA; Nilsson-Ehle, I; Nilsson-Ehle, P; Sjövall, J, 1985
)
0.27
" Amoxycillin, clavulanic acid in combination with either amoxycillin or ticarcillin, temocillin and cloxacillin displaced bilirubin at concentrations much higher than those found clinically."( Displacement of bilirubin from cord serum by sulphadimethoxine, amoxycillin, clavulanic acid in combination with either amoxycillin or ticarcillin, temocillin and cloxacillin.
Davies, BE, 1985
)
0.27
" Combined with amoxicillin, YTR 830 is a potentially useful agent for therapy of many bacterial infections."( Comparative activities of the beta-lactamase inhibitors YTR 830, sodium clavulanate, and sulbactam combined with amoxicillin or ampicillin.
Aronoff, SC; Jacobs, MR; Johenning, S; Yamabe, S, 1984
)
0.27
"The in-vitro activity of ticarcillin in combination with clavulanic acid was compared with that of ticarcillin alone, piperacillin, cefotaxime and, where appropriate, other beta-lactams against a total of 301 recent clinical isolates and characterized beta-lactamase producers."( Clavulanic acid in combination with ticarcillin: an in-vitro comparison with other beta-lactams.
Clarke, AM; Zemcov, SJ, 1984
)
0.27
" This study demonstrated the efficacy of penicillin and clavulanic acid in the treatment of infections caused by Bacteroides fragilis alone or in combination with beta-lactamase-producing aerobic bacteria."( Antibiotic and clavulanic acid treatment of subcutaneous abscesses caused by Bacteroides fragilis alone or in combination with aerobic bacteria.
Brook, I; Coolbaugh, JC; Walker, RI, 1983
)
0.27
"The comparative in vitro activity of amoxicillin alone and in combination with clavulanic acid against 15 isolates of Mycobacterium tuberculosis was evaluated by broth dilution susceptibility testing."( In vitro activity of amoxicillin in combination with clavulanic acid against Mycobacterium tuberculosis.
Cynamon, MH; Palmer, GS, 1983
)
0.27
"We compared responses to amoxicillin combined with clavulanic acid (ACA) with a cefaclor regimen in children with skin and soft tissue infections (impetigo and cellulitis) due to Staphylococcus aureus, Streptococcus pyogenes, and Haemophilus species."( Amoxicillin combined with clavulanic acid for the treatment of soft tissue infections in children.
Campos, JM; Fleisher, GR; Wilmott, CM, 1983
)
0.27
"In vitro activity against 100 strains of Bacteroides fragilis of ticarcillin alone and combined with 4 or 8 mg of clavulanic acid was compared with those of cefoxitin, cefotaxime, ceftazidime, lamoxactam , ceftriaxone and metronidazole."( [Comparative bacteriostatic activity of ticarcillin, alone and combined with clavulanic acid, 5 cephalosporins and metronidazole against 100 strains of Bacteroides fragilis].
Bebear, C; de Barbeyrac, B; Quentin, C, 1984
)
0.27
" pneumophila activity was observed for ceftriaxone (32 micrograms/ml), piperacillin (32 micrograms/ml), tazobactam alone (16 micrograms/ml), clavulanate alone (2 micrograms/ml), or tazobactam in combination with ceftriaxone (ceftriaxone/tazobactam at 32/4 and 16/16 micrograms/ml) or piperacillin (32/4 micrograms/ml)."( In vitro extracellular and intracellular activities of clavulanic acid and those of piperacillin and ceftriaxone alone and in combination with tazobactam against clinical isolates of Legionella species.
Edelstein, MA; Edelstein, PH, 1994
)
0.29
" However, strains expressing class A beta-lactamase were susceptible to cefodizime in combination with clavulanic acid."( In vitro activity of cefodizime (HR-221) in combination with beta-lactamase inhibitors.
Amicosante, G; Franceschini, N; Oratore, A; Perilli, M; Segatore, B; Setacci, D, 1993
)
0.29
" The MIC of amoxycillin in combination with clavulanic acid was > or =2 mg/L for 27/30 (90%) isolates."( Susceptibility of multidrug-resistant strains of Mycobacterium tuberculosis to amoxycillin in combination with clavulanic acid and ethambutol.
Abate, G; Miörner, H, 1998
)
0.3
"The antimicrobial efficacies of beta-lactams alone and in combination with beta-lactamase inhibitors were investigated by applying a rabbit tissue cage model against a strain of Pseudomonas aeruginosa with an inducible AmpC (iAmpC) beta-lactamase."( Pharmacodynamic study of beta-lactams alone and in combination with beta-lactamase inhibitors against Pseudomonas aeruginosa possessing an inducible beta-lactamase.
Li, C; Lister, PD; Nicolau, DP; Nightingale, CH; Quintiliani, R, 2004
)
0.32
" We evaluated in a murine model of tuberculosis the activity of carbapenems alone and combined with clavulanate against Mycobacterium tuberculosis."( Activity of carbapenems combined with clavulanate against murine tuberculosis.
Jarlier, V; Mainardi, JL; Truffot, C; Veziris, N, 2011
)
0.37
"2%) of the 121 MDR-TB strains were subjected to a synergistic effect when the drug was combined with sulbactam, tazobactam, or clavulanate, respectively."( In Vitro Activity of β-Lactams in Combination with β-Lactamase Inhibitors against Multidrug-Resistant Mycobacterium tuberculosis Isolates.
Lu, J; Pang, Y; Wang, Y; Zhang, D, 2016
)
0.43

Bioavailability

Clavulanic acid is well absorbed when given by mouth. A formulation with amoxycillin (Augmentin; Beechams) is now available for clinical use.

ExcerptReferenceRelevance
"The pharmacokinetics and bioavailability of ticarcillin and clavulanate were determined after intravenous (i."( Pharmacokinetics and bioavailability of ticarcillin and clavulanate in foals after intravenous and intramuscular administration.
Baggot, JD; Hietala, SK; Pryor, P; Spensley, MS; Wilson, WD, 1991
)
0.28
"9 hours, with bioavailability of 54."( Pharmacokinetics of intravenously and intramuscularly administered ticarcillin and clavulanic acid in foals.
Beech, J; Simmons, RD; Sweeney, RW, 1988
)
0.27
" The bioavailability of ticarcillin was 84."( Pharmacokinetics of ticarcillin and clavulanic acid given in combination to adult horses by intravenous and intramuscular routes.
Beech, J; Simmons, RD; Soma, LR; Sweeney, RW, 1988
)
0.27
" In spite of initial faster absorption, the intramuscular bioavailability of CLA (65."( Serum levels and pharmacokinetics of ticarcillin and clavulanic acid in dog following parenteral administration of Timentin.
Garg, RC; Keefe, TJ; Vig, MM, 1987
)
0.27
" The mean absolute bioavailability was 64%."( The disposition of clavulanic acid in man.
Allen, GD; Bolton, GC; Davies, BE; Filer, CW; Jeffery, DJ, 1986
)
0.27
" 1980] have shown that the bioavailability of Augmentin is not affected by food."( Augmentin bioavailability following cimetidine, aluminum hydroxide and milk.
Clarke, HL; Horton, R; Jackson, D; Lau, D; Staniforth, DH, 1985
)
0.27
" Concentrations of the drugs in blood, tissue fluid and skin showed that both drugs were sufficiently well absorbed and distributed to allow a prediction of efficacy against infections caused by beta-lactamase producing bacteria."( Clavulanate-potentiated amoxycillin: activity in vitro and bioavailability in the dog.
Buswell, JF; Bywater, RJ; Palmer, GH; Stanton, A, 1985
)
0.27
"The bioavailability and pharmacokinetics of clavulanic acid were studied following oral solution and rapid intravenous administration to healthy volunteers."( Bioavailability and pharmacokinetics of clavulanic acid in healthy subjects.
Clarke, JG; Coates, PE; Davies, BE; Sutton, JA; Thawley, AR, 1985
)
0.27
" The bioavailability of the oral dose averaged 60."( Pharmacokinetics of clavulanic acid, given in combination with amoxycillin, in volunteers.
Fellner, H; Hedström, SA; Nilsson-Ehle, I; Nilsson-Ehle, P; Sjövall, J, 1985
)
0.27
" Clavulanic acid is well absorbed when given by mouth and a formulation with amoxycillin (Augmentin; Beechams) is now available for clinical use."( The history and background of Augmentin.
Rolinson, GN, 1982
)
0.26
" Bioavailability was 27% for amoxicillin and 50% for clavulanic acid."( Pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous and oral administration in goats.
Carceles, CM; Carli, S; Escudero, E; Serrano, JM; Vicente, MS, 1995
)
0.29
" The bioavailability after the intramuscular injection was high and similar for both drugs (75."( Pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous and intramuscular administration to pigeons.
Carceles, CM; Escudero, E; Vicente, MS,
)
0.13
" Excellent tissue pharmacokinetics and oral bioavailability suggest usefulness in the treatment of complicated intra-abdominal infections."( Trovafloxacin in the treatment of intra-abdominal infections: results of a double-blind, multicenter comparison with imipenem/cilastatin. Trovafloxacin Surgical Group.
Bur, F; Donahue, PE; Luke, DR; Mintz, SJ; Smith, DL; Yellin, AE, 1998
)
0.3
" administration both drugs were poorly absorbed into the plasma."( Administration of ticarcillin in combination with clavulanic acid intravenously and intrauterinely to clinically normal oestrous mares.
Papich, MG; Van Camp, SD; Whitacre, MD, 2000
)
0.31
" The ozone absorption rate ranged between 53% (ozonation) and 68% (perozonation)."( Combined chemical and biological oxidation of penicillin formulation effluent.
Alaton, IA; Baykal, E; Dogruel, S; Gerone, G, 2004
)
0.32
" Data available in the literature also suggest a possible interaction between amoxicillin and clavulanic acid that might decrease the absolute bioavailability of clavulanic acid."( New formulations of amoxicillin/clavulanic acid: a pharmacokinetic and pharmacodynamic review.
Sánchez Navarro, A, 2005
)
0.33
" Human oral bioavailability is an important pharmacokinetic property, which is directly related to the amount of drug available in the systemic circulation to exert pharmacological and therapeutic effects."( Hologram QSAR model for the prediction of human oral bioavailability.
Andricopulo, AD; Moda, TL; Montanari, CA, 2007
)
0.34
" bioavailability was found to be 22."( Disposition and oral bioavailability of amoxicillin and clavulanic acid in pigs.
Baert, K; Croubels, S; De Backer, P; De Boever, S; Gasthuys, F; Reyns, T; Schauvliege, S, 2007
)
0.34
"Oral bioavailability (F) is a product of fraction absorbed (Fa), fraction escaping gut-wall elimination (Fg), and fraction escaping hepatic elimination (Fh)."( Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
Chang, G; El-Kattan, A; Miller, HR; Obach, RS; Rotter, C; Steyn, SJ; Troutman, MD; Varma, MV, 2010
)
0.36
" Oral bioavailability of amoxicillin was 79."( Population pharmacokinetics and dosing simulations of amoxicillin in obese adults receiving co-amoxiclav.
Burdet, C; Carette, C; Crémieux, AC; Czernichow, S; Duval, X; El-Helali, N; Hammas, K; Massias, L; Mellon, G; Mentré, F, 2020
)
0.56

Dosage Studied

Chronic dosing of clavulanic acid alleviates neuropathic pain in rats and up-regulates glutamate transporters both in vitro and in vivo. The aim of the study was to assess the pharmacokinetic properties of amoxicillin and clavuranic acid in 8:1 with different dosage.

ExcerptRelevanceReference
" The emergence of the newer antibiotic classes, including the second and third-generation cephalosporins and the fluoroquinolones, has provided the clinician with agents that offer a broad spectrum of activity, good patient acceptance, a well-tolerated safety profile, and convenient dosage regimens due to their unique pharmacokinetic profiles."( New considerations in treatment of urinary tract infections in adults.
Faro, S, 1992
)
0.28
" Ticarcillin and clavulanic acid is a safe and effective alternative to gentamicin and clindamycin in the treatment of secondary bacterial peritonitis and offers advantages in dosing simplicity and freedom from ototoxic and nephrotoxic effects."( A randomized trial of ticarcillin and clavulanate versus gentamicin and clindamycin in patients with complicated appendicitis.
Levine, BA; Sirinek, KR, 1991
)
0.28
"Concentrations of amoxycillin/clavulanic acid achievable in the respiratory tract following oral dosage were assessed for in-vitro activity against beta-lactamase-producing strains of Branhamella catarrhalis and Haemophilus influenzae."( Effect of low concentrations of clavulanic acid on the in-vitro activity of amoxycillin against beta-lactamase-producing Branhamella catarrhalis and Haemophilus influenzae.
Cooper, CE; Slocombe, B; White, AR, 1990
)
0.28
" While it is eliminated mainly by the kidney, 10-20% of the drug is eliminated in the bile and ceftriaxone salt precipitates have been described in the gallbladder of animals dosed with ceftriaxone."( Incidence of gallbladder lithiasis after ceftriaxone treatment.
Anderegg, A; Cantoni, L; Cometta, A; Gallot-Lavallée-Villars, S; Glauser, MP; Gonvers, JJ; Iten, A, 1990
)
0.28
" Of the 24 children with urinary tract infection for the first time, combination therapy, dosing twice daily for 5 days (40 mg/kg."( Amoxycillin and clavulanic acid in the treatment of urinary tract infections in children.
D'Eufemia, P; Giardini, O; Martino, F; Ruberto, U,
)
0.13
"5 mg/5 ml (4:1 ratio) at the dosage of about 17 mg/kg in two daily administrations according to the weight of the patients was used."( [Pediatric suspensions of amoxicillin and clavulanic acid in the treatment of bacterial infections of otorhinolaryngologic importance and the upper respiratory tract].
Amendola, F; De Mattia, D; Natuzzi, M; Schettini, F, 1989
)
0.28
" The dosage of amoxycillin was 50 mg/kg/day given together with probenecid and divided in 3 doses."( Comparison of amoxycillin/clavulanate with amoxycillin in children and adults with chronic obstructive pulmonary disease and infection with Haemophilus influenzae.
Bondesson, G; Høiby, N; Jensen, T; Koch, C; Pedersen, SS; Stafanger, G, 1988
)
0.27
" The dosing requirements for the combination of TIC and CLAV in patients with renal failure are considered."( Pharmacokinetics of clavulanic acid-potentiated ticarcillin in renal failure.
Boulton-Jones, M; Henderson, I; Payton, CD; Stewart, MJ; Watson, ID, 1987
)
0.27
" Dosage recommendations are suggested which prevent undue accumulations of amoxicillin while maintaining adequate concentrations of clavulanic acid."( Differential effect of impaired renal function on the kinetics of clavulanic acid and amoxicillin.
Descoeudres, C; Frey, FJ; Horber, FF; Murray, AT; Reubi, FC, 1986
)
0.27
" Clavulanic acid was the major radioactive component present in 0-24 h urine following oral dosing (23% of the dose)."( The disposition of clavulanic acid in man.
Allen, GD; Bolton, GC; Davies, BE; Filer, CW; Jeffery, DJ, 1986
)
0.27
" For general condition, dogs dosed with CVA-K at 100 mg/kg showed reddening of the skin and mucous membranes, shaking of the head, facial oedema, a decrease in food intake and a reduction in body weight."( [Chronic intravenous toxicity studies of potassium clavulanate and BRL28500 in dogs].
Katayama, T; Kobayashi, K; Koshima, Y; Koyanagi, J; Koyu, A; Kurakata, Y; Nagata, R; Nishioka, Y; Onishi, M; Sato, M, 1986
)
0.27
" A formulation containing amoxycillin trihydrate and potassium clavulanate (4:1) was dosed to beagles at 12."( Clavulanate-potentiated amoxycillin: activity in vitro and bioavailability in the dog.
Buswell, JF; Bywater, RJ; Palmer, GH; Stanton, A, 1985
)
0.27
" The bactericidal effects of the antibiotic combination were measured in an in vitro kinetic model in which the drug concentrations were varied to simulate those measured in humans after intravenous dosing with ticarcillin (3."( Antibacterial activity of ticarcillin in the presence of clavulanate potassium.
Beale, AS; Boon, RJ; Griffin, KE; Slocombe, B; Stokes, DH; Sutherland, R; White, AR, 1985
)
0.27
" Due to accumulation, dosage adjustment is required for patients with renal insufficiency."( Pharmacology of ticarcillin combined with clavulanic acid in humans.
Chin, NX; Neu, HC; Scully, BE, 1985
)
0.27
" A higher bacterial kill rate was observed when the antibiotic dosage was increased beyond the minimum concentration where an antibacterial effect was seen; this was not demonstrable by traditional agar dilution tests."( Antibacterial activity and kill kinetics of amoxicillin-clavulanic acid combinations against Escherichia coli and Klebsiella aerogenes.
Bergan, T; Fuglesang, JE,
)
0.13
" These data indicate that dosage adjustments for amoxicillin/clavulanic acid may be required in patients with chronic renal failure who are on hemodialysis."( Effects of hemodialysis on the pharmacokinetics of amoxicillin/clavulanic acid combination.
Brass, C; Kohli, R; Slaughter, RL, 1984
)
0.27
" Mean plasma concentrations 5 min after dosing were 89."( Single-dose pharmacokinetics of intravenous clavulanic acid with amoxicillin in pediatric patients.
Casey, PA; Cooper, DL; Schaad, UB, 1983
)
0.27
" The smaller dosage resulted in suboptimal plasma concentrations."( Pharmacokinetics of potassium clavulanate in combination with amoxicillin in pediatric patients.
Kusmiesz, H; Nelson, JD; Shelton, S, 1982
)
0.26
" Even though the differences in disposition kinetics of both drugs were statistically significant, the same intravenous dosing rate of this antimicrobial combination can generally be used in sheep and goats."( Comparative pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous administration to sheep and goats.
Baggot, JD; Carceles, CM; Escudero, E, 1995
)
0.29
" Our results suggest that the current dosing recommendations of 75 mg/kg every 12 h risk subtherapeutic clavulanic acid concentrations and that 50 mg/kg every 6 h is a more rational dosing strategy."( Ticarcillin-clavulanic acid pharmacokinetics in preterm neonates with presumed sepsis.
Burstein, AH; Carlos, RQ; Diaz, PR; Forrest, A; Gal, P; Ransom, JL; Wyble, LE, 1994
)
0.29
" Serum bactericidal titers were determined and used to calculate the duration of measurable bactericidal activity over the dosing interval of each of the regimens against two clinical isolates of Bacillus fragilis, Escherichia coli, Enterococcus faecalis, and Pseudomonas aeruginosa."( Comparison of the bactericidal activities of piperacillin-tazobactam, ticarcillin-clavulanate, and ampicillin-sulbactam against clinical isolates of Bacteroides fragilis, Enterococcus faecalis, Escherichia coli, and Pseudomonas aeruginosa.
Klepser, ME; Marangos, MN; Nicolau, DP; Nightingale, CH; Quintiliani, R; Zhu, Z, 1997
)
0.3
" These data may have implications for reducing the dosage of amoxicillin-clavulanate."( Postantibiotic and post-beta-lactamase inhibitor effects of amoxicillin plus clavulanate.
Molesworth, SJ; Rittenhouse, S; Sutherland, R; Thorburn, CE, 1996
)
0.29
" From a single administration it is proposed that an intramuscular dosage regimen of 105 mg kg(-1) of the combination (84 mg kg(-1) of amoxicillin and 21 mg kg(-1) of clavulanic acid) every 12 hours will achieve minimum concentrations > or =0."( Pharmacokinetics of amoxicillin/clavulanic acid combination after intravenous and intramuscular administration to pigeons.
Carceles, CM; Escudero, E; Vicente, MS,
)
0.13
"In vivo, serum concentrations of beta-lactamase inhibitors measured during the last part of the dosing interval are below the levels associated with in vitro activity."( [In vitro demonstration of a true post-beta-lactamases inhibitor effect (PLIE) of clavulanic acid on Klebsiella pneumoniae and Haemophilus influenzae].
Dhoyen, N; Jehl, F; Linger, L; Monteil, H; Murbach, V, 1999
)
0.3
" The dosage was 500 mg once or twice a day depending on the studies."( [Levofloxacin in the treatment of community-acquired pneumococcal pneumonia].
Léophonte, P; Veyssier, P, 1999
)
0.3
" Cost saving may be achieved with trovafloxacin due to the lack of any need to monitor creatinine levels and the once-daily dosing regimen that allows a switch to the same orally administered drug."( Treatment of complicated intra-abdominal infections: comparison of the tolerability and safety of intravenous/oral trovafloxacin versus intravenous imipenem/cilastatin switching to oral amoxycillin/clavulanic acid.
Luke, DR; Peterson, J,
)
0.13
" Despite the marked effect of certain antibiotic agents upon spermatogenesis, it appears that clavulanic acid-potentiated amoxycillin can be used in dogs at up to twice the therapeutic dosage recommended by the manufacturer without a deleterious effect upon semen quality."( Effect of clavulanic acid-potentiated amoxycillin on semen quality in dogs.
England, GC, 1999
)
0.3
" Thirteen adverse events were reported post dosing by 7 subjects."( Bioequivalence study of a novel Solutab tablet formulation of amoxicillin/clavulanic acid versus the originator film-coated tablet.
Bertola, MA; Rayer, B; Sourgens, H; Steinbrede, H; Verschoor, JS, 2001
)
0.31
"A simple and sensitive liquid chromatographic method with electrochemical (EC) detection is described for the quantitative determination of amoxycillin and clavulanic acid in pharmaceutical dosage forms."( Simultaneous determination of amoxycillin and clavulanic acid in pharmaceutical dosage forms by LC with amperometric detection.
Aghazadeh, A; Kazemifard, G, 2001
)
0.31
" The new formulation consisted of 1 layer of immediate-release amoxicillin and clavulanate and another of sustained-release amoxicillin in a proportion such that for an amoxicillin minimum inhibitory concentration (MIC) of 4 microg/mL, the time above the MIC (T >MIC) would be approximately > or = 40% over a 12-hour dosing interval."( The clinical pharmacokinetics of a new pharmacokinetically enhanced formulation of amoxicillin/clavulanate.
Allen, A; Bird, N; Davy, M; Dewit, O; Kaye, CM; McDonagh, M; Perry, S; Storm, K, 2001
)
0.31
"4% of a 12-hour dosing interval, a value that cannot be achieved with existing approved doses and formulations of amoxicillin/clavulanate."( The clinical pharmacokinetics of a new pharmacokinetically enhanced formulation of amoxicillin/clavulanate.
Allen, A; Bird, N; Davy, M; Dewit, O; Kaye, CM; McDonagh, M; Perry, S; Storm, K, 2001
)
0.31
"The PLIE could be one of several factors explaining why beta-lactam/beta-lactamase inhibitor combinations remain effective throughout the dosing interval, even if a few hours after in vivo administration, serum concentrations of beta-lactamase inhibitor fall below levels that are active in vitro."( Evidence for a true post-beta-lactamase-inhibitor effect of clavulanic acid against Klebsiella pneumoniae and Haemophilus influenzae.
Dhoyen, N; Jehl, F; Linger, L; Monteil, H; Murbach, V, 2001
)
0.31
" Today, the beta-lactam antibiotics, particularly penicillins and cephalosporins, represent the world's major biotechnology products with worldwide dosage form sales of approximately 15 billion US dollars or approximately 65% of the total world market for antibiotics."( Industrial production of beta-lactam antibiotics.
Elander, RP, 2003
)
0.32
" The dosing regimens were as follows: piperacillin alone, 4 g piperacillin/0."( Pharmacodynamic study of beta-lactams alone and in combination with beta-lactamase inhibitors against Pseudomonas aeruginosa possessing an inducible beta-lactamase.
Li, C; Lister, PD; Nicolau, DP; Nightingale, CH; Quintiliani, R, 2004
)
0.32
" Eradication was achieved with the enhanced formulation for strains with a MIC of < or =2 mg/L, however, regrowth occurred with the other dosing regimens."( Pharmacodynamic studies of amoxicillin against Streptococcus pneumoniae: comparison of a new pharmacokinetically enhanced formulation (2000 mg twice daily) with standard dosage regimens.
Cars, O; Löwdin, E; Odenholt, I, 2004
)
0.32
" This study also investigated whether urinary concentrations obtained after dosing cover E coli strains categorized as intermediately resistant and resistant based on current Clinical and Laboratory Standards Institute (formerly NCCLS) breakpoints in uncomplicated cystitis."( Urinary concentrations and bactericidal activity against amoxicillin-nonsusceptible strains of Escherichia coli with single-dose, oral, sustained-release amoxicillin/clavulanic acid: a phase I, open-label, noncomparative clinical trial in healthy voluntee
Aguilar, L; Carcas, A; Carpintero, Y; del Prado, G; Giménez, MJ; Gracia, M; Huelves, L; Maín, CM; Ponte, C; Soriano, F, 2005
)
0.33
"In this Phase I study in healthy volunteers, urinary concentrations after dosing with amoxicillin/clavulanic acid 2000/125 mg SR showed bactericidal activity against the amoxicillin-susceptible and intermediately resistant strains of E coli."( Urinary concentrations and bactericidal activity against amoxicillin-nonsusceptible strains of Escherichia coli with single-dose, oral, sustained-release amoxicillin/clavulanic acid: a phase I, open-label, noncomparative clinical trial in healthy voluntee
Aguilar, L; Carcas, A; Carpintero, Y; del Prado, G; Giménez, MJ; Gracia, M; Huelves, L; Maín, CM; Ponte, C; Soriano, F, 2005
)
0.33
"We conducted a prospective pharmacokinetic study of oral co-amoxiclav in patients with melioidosis to determine the optimal dosage and dosing interval in this potentially fatal infection."( Pharmacokinetic and pharmacodynamic assessment of co-amoxiclav in the treatment of melioidosis.
Chaowagul, W; Chierakul, W; Dance, DA; Day, NP; Lindegardh, N; Maharjan, B; Peacock, SJ; Pongtavornpinyo, W; Short, JM; Singtoroj, T; Teparrukkul, P; Wangboonskul, J; White, NJ; Wuthiekanun, V, 2006
)
0.33
" The experimental bactericidal activity of cefditoren is maintained over the dosing interval regardless of the presence of a mutation in the ftsI gene or beta-lactamase production."( influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
Aguilar, L; Alou, L; Cafini, F; Coronel, P; Echeverría, O; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2007
)
0.34
") dosage of 20 mg/kg of amoxicillin and 5 mg/kg of clavulanic acid."( Disposition and oral bioavailability of amoxicillin and clavulanic acid in pigs.
Baert, K; Croubels, S; De Backer, P; De Boever, S; Gasthuys, F; Reyns, T; Schauvliege, S, 2007
)
0.34
" We used NONMEM and S-ADAPT for population pharmacokinetic analysis and a target time of the non-protein-bound drug concentration above the MIC for > or = 50% of the dosing interval for near-maximal bactericidal activity in serum."( Bone penetration of amoxicillin and clavulanic acid evaluated by population pharmacokinetics and Monte Carlo simulation.
Bulitta, JB; Gusinde, J; Hennig, FF; Holzgrabe, U; Kinzig, M; Landersdorfer, CB; Sörgel, F, 2009
)
0.35
" The CLA dosage (13 mg/kg of body weight given intraperitoneally) was chosen to reach a maximum concentration of the drug in serum similar to that in humans and a time during which the serum CLA concentration remained above the MIC equivalent to 40% of the interval between doses."( In vitro activity and in vivo efficacy of clavulanic acid against Acinetobacter baumannii.
Beceiro, A; Bou, G; Docobo-Pérez, F; Domínguez-Herrera, J; López-Rojas, R; Pachón, J, 2009
)
0.35
"Two accurate, precise, sensitive and economical procedures for simultaneous estimation of Cefpodoxime proxetil and Potassium clavulanate in tablet dosage form have been developed."( Simultaneous spectrophotometric determination of Cefpodoxime proxetil and Potassium clavulanate.
Gandhi, SV; Patil, NG; Patil, UP, 2009
)
0.35
" The aim of the study was to assess the pharmacokinetic properties of amoxicillin and clavulanic acid in 8:1 with different dosage in healthy volunteers and provide support for this drug to obtain marketing authorization in China."( Pharmacokinetics study of amoxycillin and clavulanic acid (8:1)--a new combination in healthy Chinese adult male volunteers using the LC-MS/MS method.
Jia, Z; Men, X; Wang, R; Wang, Y; Xie, H; Xu, L; Zhang, J; Zhang, Q, 2013
)
0.39
" Based on pharmacokinetic/pharmacodynamic indexes reported for beta-lactams against other bacterial pathogens, a cumulative percentage of a 24-h period that the drug concentration exceeds the MIC under steady-state pharmacokinetic conditions (%TMIC) of 20 to 40% was achieved in mice using a suitable dosing regimen."( In vitro and in vivo efficacy of β-lactams against replicating and slowly growing/nonreplicating Mycobacterium tuberculosis.
Ahuja, V; Balasubramanian, V; Balganesh, M; Bhattacharjee, D; Dinesh, N; Ganguly, S; Kumar, N; Panduga, V; Parab, M; Ramachandran, V; Reddy, J; Shandil, R; Sharma, S; Solapure, S; Vishwas, KG, 2013
)
0.39
" The dosage of amoxicillin was considered to be appropriate when in accord with clinical practice guidelines, that is, 80-90 mg/kg/day."( High-dose amoxicillin with clavulanate for the treatment of acute otitis media in children.
Chu, CH; Ho, CY; Huang, CY; Liao, WH; Lin, LY; Shiao, AS; Tu, TY; Wang, MC, 2013
)
0.39
"The majority of prescriptions were under dosage (89."( High-dose amoxicillin with clavulanate for the treatment of acute otitis media in children.
Chu, CH; Ho, CY; Huang, CY; Liao, WH; Lin, LY; Shiao, AS; Tu, TY; Wang, MC, 2013
)
0.39
"Amoxicillin-clavulanate (A/C) is currently the most effective oral antimicrobial in treating children with acute otitis media (AOM), but the standard dosage of 90 mg amoxicillin/6."( Reduced-Concentration Clavulanate for Young Children with Acute Otitis Media.
Beumer, J; Bhatnagar, S; Haralam, M; Hoberman, A; Jeong, JH; Kearney, DH; Kurs-Lasky, M; Martin, JM; Miah, MK; Muñiz, G; Nagg, JP; Paradise, JL; Pope, MA; Rockette, HE; Shaikh, N; Shope, TR; Venkataramanan, R; Zhao, W, 2017
)
0.46
"Chronic dosing of clavulanic acid alleviates neuropathic pain in rats and up-regulates glutamate transporters both in vitro and in vivo."( The β-lactam clavulanic acid mediates glutamate transport-sensitive pain relief in a rat model of neuropathic pain.
Bjerrum, OJ; Gegelashvili, G; Heegaard, AM; Kristensen, PJ; Munro, G, 2018
)
0.48
" Solid dosage forms containing amoxicillin alone or in combination with clavulanic acid as well as analgesics containing paracetamol alone or in combination with other drugs were sampled in a randomized fashion from the formal market (pharmacies) and by convenient sampling from the informal market."( Drug Quality in South Africa: A Field Test.
Dressman, J; Katerere, DR; Lehmann, A, 2018
)
0.48
" Since the achievement and maintenance of optimum therapeutic levels of β-lactam antibiotics is critical for the resolution of many infectious clinical situations, and to avoid antibiotic resistance generation, the design of new non-aqueous dosage forms is urgent."( A Natural Deep Eutectic Solvent Formulated to Stabilize β-Lactam Antibiotics.
Calderón, C; M Munita, J; Martínez, F; Olivares, B; R Campodonico, P; Rivas, L, 2018
)
0.48
" No dose-response relationship was found between exposure in terms of the defined daily dose and major malformations."( The safety of amoxicillin and clavulanic acid use during the first trimester of pregnancy.
Daniel, S; Doron, M; Fishman, B; Koren, G; Levy, A; Lunenfeld, E, 2019
)
0.51
" Dosing in this case was complicated by the necessity for RRT to treat a drug overdose with carbamazepine, despite normal native renal function."( Amoxicillin-Clavulanate Dosing in the Intensive Care Unit: The Additive Effect of Renal Replacement Therapy in a Patient with Normal Kidney Function.
Lipman, J; Livermore, A; Lonsdale, DO; McWhinney, B; Roberts, JA; Ungerer, JPJ, 2019
)
0.51
" Findings from this study aid in ameliorating current dosing regimens to optimise antibiotic efficacy."( Suitability of Amoxicillin-Clavulanic Acid for Administration via Prolonged Infusion.
Barton, S; Dixon, B; Fawaz, S; Mohamed, A; Nabhani-Gebara, S, 2020
)
0.56
"Pneumonia, skin and soft tissue infections are more frequent in obese patients and are most often treated by co-amoxiclav, using similar dosing regimens to those used for non-obese subjects."( Population pharmacokinetics and dosing simulations of amoxicillin in obese adults receiving co-amoxiclav.
Burdet, C; Carette, C; Crémieux, AC; Czernichow, S; Duval, X; El-Helali, N; Hammas, K; Massias, L; Mellon, G; Mentré, F, 2020
)
0.56
" Its inclusion in the treatment of infectious diseases of broilers requires determination of pharmacokinetic and pharmacodynamic parameters in order to determine the appropriate dosage for broilers and ensure safety of chicken products for human health."( Mass spectrometric identification and quantification of the antibiotic clavulanic acid in broiler chicken plasma and meat as a necessary analytical tool in finding ways to increase the effectiveness of currently used antibiotics in the treatment of broile
Bartejsova, I; Matiaskova, K; Nedbalcova, K; Putecova, K; Stastny, K; Zouharova, M, 2021
)
0.62
" The dosing of clavulanic acid is currently based on that of the partner drug (amoxicillin or ticarcillin)."( Pharmacokinetics of Clavulanic Acid in the Pediatric Population: A Systematic Literature Review.
Allegaert, K; Keij, FM; Koch, BCP; Kornelisse, RF; Muller, AE; Reiss, IKM; Tramper-Stranders, GA, 2022
)
0.72
" Neonates (postmenstrual age ≥35 weeks, postnatal age 0-28 days, bodyweight ≥2 kg) in whom prolonged antibiotic treatment was indicated because of a probable bacterial infection, were randomly assigned (1:1) to switch to an oral suspension of amoxicillin 75 mg/kg plus clavulanic acid 18·75 mg/kg (in a 4:1 dosing ratio, given daily in three doses) or continue on intravenous antibiotics (according to the local protocol)."( Efficacy and safety of switching from intravenous to oral antibiotics (amoxicillin-clavulanic acid) versus a full course of intravenous antibiotics in neonates with probable bacterial infection (RAIN): a multicentre, randomised, open-label, non-inferiorit
Allegaert, K; Baartmans, MGA; den Butter, PCP; Driessen, GJA; Eijkemans, M; Hartwig, NG; Heidema, J; Keij, FM; Kenter, S; Kornelisse, RF; Meijssen, CB; Norbruis, OF; Qi, H; Reiss, IKM; Stam-Stigter, GM; Tramper-Stranders, GA; van Beek, RHT; van Dalen-Vink, I; van den Berg, MM; van der Meer-Kappelle, LH; van der Sluijs-Bens, J; van Driel, A; van Rooij, LGM; van Rossem, MC; von Lindern, JS, 2022
)
0.72
"Selection of an antibiotic and dosing regimen requires consideration of multiple factors including microbiological data, site of infection, pharmacokinetics, and how it relates to the pharmacodynamic target."( Shedding Light on Amoxicillin, Amoxicillin-clavulanate, and Cephalexin Dosing in Children from a Pharmacist's Perspective.
Bio, LL; Yu, D, 2022
)
0.72
" The starting dosage was 2875 g of amoxicillin twice daily and 125 mg of clavulanic acid twice daily."( Breaking Antimicrobial Resistance: High-Dose Amoxicillin with Clavulanic Acid for Urinary Tract Infections Due to Extended-Spectrum Beta-Lactamase (ESBL)-Producing Klebsiella pneumoniae.
Ciszek, M; Hryniewiecka, E; Jasińska, K; Pączek, L; Wilkowski, P, 2023
)
0.91
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Roles (4)

RoleDescription
EC 3.5.2.6 (beta-lactamase) inhibitorAn EC 3.5.2.* (non-peptide cyclic amide C-N hydrolase) inhibitor that interferes with the action of beta-lactamase (EC 3.5.2.6).
antibacterial drugA drug used to treat or prevent bacterial infections.
bacterial metaboliteAny prokaryotic metabolite produced during a metabolic reaction in bacteria.
anxiolytic drugAnxiolytic drugs are agents that alleviate anxiety, tension, and anxiety disorders, promote sedation, and have a calming effect without affecting clarity of consciousness or neurologic conditions.
[role information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Drug Classes (1)

ClassDescription
oxapenamA fused-ring beta-lactam system where the beta-lactam ring is fused to a 1,3-oxazolidine ring.
[compound class information is derived from Chemical Entities of Biological Interest (ChEBI), Hastings J, Owen G, Dekker A, Ennis M, Kale N, Muthukrishnan V, Turner S, Swainston N, Mendes P, Steinbeck C. (2016). ChEBI in 2016: Improved services and an expanding collection of metabolites. Nucleic Acids Res]

Protein Targets (37)

Inhibition Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Beta-lactamase Klebsiella pneumoniaeIC50 (µMol)1.72000.08000.90001.7200AID519751
Beta-lactamase Escherichia coliIC50 (µMol)0.07000.01002.09336.2000AID326273
Beta-lactamase Citrobacter gilleniiIC50 (µMol)0.00900.00900.02450.0400AID285444
Beta-lactamase Escherichia coliIC50 (µMol)500.00000.02600.02900.0320AID394491
Beta-lactamase Shouchella clausiiIC50 (µMol)0.08500.00400.05470.0850AID373218
Beta-lactamase Pseudomonas aeruginosaIC50 (µMol)0.10000.06000.17000.3700AID511293
Beta-lactamase Pseudomonas aeruginosaIC50 (µMol)0.10000.10001.70003.0000AID495659
Bile salt export pumpRattus norvegicus (Norway rat)IC50 (µMol)1,000.00000.40002.75008.6000AID1209456
Bile salt export pumpHomo sapiens (human)IC50 (µMol)1,000.00000.11007.190310.0000AID1209455
Beta-lactamaseStaphylococcus aureusIC50 (µMol)0.08000.08001.95096.5000AID43913
Beta-lactamaseEscherichia coli K-12IC50 (µMol)500.00750.01502.46578.0000AID154308; AID43568
Beta-lactamaseEnterobacter cloacaeIC50 (µMol)118.10000.10001.87457.7000AID297200; AID584977
Neutrophil elastaseHomo sapiens (human)IC50 (µMol)40.00000.00632.073422.3780AID66646
Beta-lactamase SHV-1Escherichia coliIC50 (µMol)0.02800.02800.12500.2220AID297199
Beta-lactamase SHV-1Klebsiella pneumoniaeIC50 (µMol)0.17000.11000.15000.1700AID519750; AID519984
Beta-lactamase SHV-1Klebsiella pneumoniaeKi2.00000.22001.24002.0000AID1801066
Beta-lactamase OXA-1Escherichia coliIC50 (µMol)3.20003.20004.00004.8000AID43565
Cytochrome P450 2B6Homo sapiens (human)IC50 (µMol)0.17000.00113.418610.0000AID519750
Beta-lactamasePseudomonas aeruginosa PAO1IC50 (µMol)50.40000.12801.69164.6000AID43885; AID584978
Beta-lactamase TEMEscherichia coliIC50 (µMol)9.25600.00191.761810.0000AID297198; AID326275; AID372630; AID43566; AID50695
Beta-lactamase TEMEscherichia coliKi0.80000.02701.82347.3000AID43582
Beta-lactamaseMycobacterium tuberculosis CDC1551Ki6.30006.30006.30006.3000AID1801074
Beta-lactamase Acinetobacter pittiiIC50 (µMol)235.52001.12001.12001.1200AID555229
Beta-lactamase Acinetobacter pittiiIC50 (µMol)1,462.48007.75807.75807.7580AID555230
Beta-lactamase Salmonella enterica subsp. enterica serovar WesthamptonIC50 (µMol)0.01000.00220.00610.0100AID556339
Beta-lactamase Pseudomonas aeruginosaIC50 (µMol)0.10000.10001.70003.0000AID495660
Beta-lactamase Klebsiella pneumoniaeIC50 (µMol)0.02000.02000.02000.0200AID519985
Class D beta-lactamaseBrachyspira pilosicoliIC50 (µMol)2.00000.16001.08002.0000AID519637
Beta-lactamase Enterobacter cloacaeIC50 (µMol)100.00003.40003.40003.4000AID50709
Beta-lactamase Pseudomonas luteolaIC50 (µMol)0.03600.03600.03800.0400AID495653
Beta-lactamase Escherichia coliIC50 (µMol)8.60000.24004.42008.6000AID372627
Beta-lactamase Serratia fonticolaIC50 (µMol)72.80006.90006.90006.9000AID374027
Beta-lactamase Escherichia coliIC50 (µMol)0.00900.00200.00550.0090AID368519
Carbapenem-hydrolyzing beta-lactamase KPCKlebsiella pneumoniaeIC50 (µMol)10.50000.37000.37200.3740AID495801
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Other Measurements

ProteinTaxonomyMeasurementAverageMin (ref.)Avg (ref.)Max (ref.)Bioassay(s)
Beta-lactamase TEMEscherichia coliActivity3.00003.00003.00003.0000AID326269
Beta-lactamase class B VIM-2 Pseudomonas aeruginosaKm5,000.00002.00006.65009.4000AID531315
[prepared from compound, protein, and bioassay information from National Library of Medicine (NLM), extracted Dec-2023]

Biological Processes (53)

Processvia Protein(s)Taxonomy
fatty acid metabolic processBile salt export pumpHomo sapiens (human)
bile acid biosynthetic processBile salt export pumpHomo sapiens (human)
xenobiotic metabolic processBile salt export pumpHomo sapiens (human)
xenobiotic transmembrane transportBile salt export pumpHomo sapiens (human)
response to oxidative stressBile salt export pumpHomo sapiens (human)
bile acid metabolic processBile salt export pumpHomo sapiens (human)
response to organic cyclic compoundBile salt export pumpHomo sapiens (human)
bile acid and bile salt transportBile salt export pumpHomo sapiens (human)
canalicular bile acid transportBile salt export pumpHomo sapiens (human)
protein ubiquitinationBile salt export pumpHomo sapiens (human)
regulation of fatty acid beta-oxidationBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transportBile salt export pumpHomo sapiens (human)
bile acid signaling pathwayBile salt export pumpHomo sapiens (human)
cholesterol homeostasisBile salt export pumpHomo sapiens (human)
response to estrogenBile salt export pumpHomo sapiens (human)
response to ethanolBile salt export pumpHomo sapiens (human)
xenobiotic export from cellBile salt export pumpHomo sapiens (human)
lipid homeostasisBile salt export pumpHomo sapiens (human)
phospholipid homeostasisBile salt export pumpHomo sapiens (human)
positive regulation of bile acid secretionBile salt export pumpHomo sapiens (human)
regulation of bile acid metabolic processBile salt export pumpHomo sapiens (human)
transmembrane transportBile salt export pumpHomo sapiens (human)
antibiotic catabolic processBeta-lactamaseEscherichia coli K-12
response to antibioticBeta-lactamaseEscherichia coli K-12
proteolysisNeutrophil elastaseHomo sapiens (human)
negative regulation of transcription by RNA polymerase IINeutrophil elastaseHomo sapiens (human)
response to yeastNeutrophil elastaseHomo sapiens (human)
leukocyte migration involved in inflammatory responseNeutrophil elastaseHomo sapiens (human)
biosynthetic process of antibacterial peptides active against Gram-negative bacteriaNeutrophil elastaseHomo sapiens (human)
proteolysisNeutrophil elastaseHomo sapiens (human)
intracellular calcium ion homeostasisNeutrophil elastaseHomo sapiens (human)
response to UVNeutrophil elastaseHomo sapiens (human)
extracellular matrix disassemblyNeutrophil elastaseHomo sapiens (human)
protein catabolic processNeutrophil elastaseHomo sapiens (human)
response to lipopolysaccharideNeutrophil elastaseHomo sapiens (human)
negative regulation of chemokine productionNeutrophil elastaseHomo sapiens (human)
negative regulation of interleukin-8 productionNeutrophil elastaseHomo sapiens (human)
positive regulation of interleukin-8 productionNeutrophil elastaseHomo sapiens (human)
defense response to bacteriumNeutrophil elastaseHomo sapiens (human)
positive regulation of MAP kinase activityNeutrophil elastaseHomo sapiens (human)
positive regulation of smooth muscle cell proliferationNeutrophil elastaseHomo sapiens (human)
negative regulation of inflammatory responseNeutrophil elastaseHomo sapiens (human)
positive regulation of immune responseNeutrophil elastaseHomo sapiens (human)
negative regulation of chemotaxisNeutrophil elastaseHomo sapiens (human)
pyroptosisNeutrophil elastaseHomo sapiens (human)
neutrophil-mediated killing of gram-negative bacteriumNeutrophil elastaseHomo sapiens (human)
neutrophil-mediated killing of fungusNeutrophil elastaseHomo sapiens (human)
positive regulation of leukocyte tethering or rollingNeutrophil elastaseHomo sapiens (human)
phagocytosisNeutrophil elastaseHomo sapiens (human)
acute inflammatory response to antigenic stimulusNeutrophil elastaseHomo sapiens (human)
xenobiotic metabolic processCytochrome P450 2B6Homo sapiens (human)
steroid metabolic processCytochrome P450 2B6Homo sapiens (human)
xenobiotic catabolic processCytochrome P450 2B6Homo sapiens (human)
cellular ketone metabolic processCytochrome P450 2B6Homo sapiens (human)
epoxygenase P450 pathwayCytochrome P450 2B6Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Molecular Functions (28)

Processvia Protein(s)Taxonomy
protein bindingBile salt export pumpHomo sapiens (human)
ATP bindingBile salt export pumpHomo sapiens (human)
ABC-type xenobiotic transporter activityBile salt export pumpHomo sapiens (human)
bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
canalicular bile acid transmembrane transporter activityBile salt export pumpHomo sapiens (human)
carbohydrate transmembrane transporter activityBile salt export pumpHomo sapiens (human)
ABC-type bile acid transporter activityBile salt export pumpHomo sapiens (human)
ATP hydrolysis activityBile salt export pumpHomo sapiens (human)
beta-lactamase activityBeta-lactamaseEscherichia coli K-12
hydrolase activityBeta-lactamaseEscherichia coli K-12
protease bindingNeutrophil elastaseHomo sapiens (human)
transcription corepressor activityNeutrophil elastaseHomo sapiens (human)
endopeptidase activityNeutrophil elastaseHomo sapiens (human)
serine-type endopeptidase activityNeutrophil elastaseHomo sapiens (human)
protein bindingNeutrophil elastaseHomo sapiens (human)
heparin bindingNeutrophil elastaseHomo sapiens (human)
peptidase activityNeutrophil elastaseHomo sapiens (human)
cytokine bindingNeutrophil elastaseHomo sapiens (human)
monooxygenase activityCytochrome P450 2B6Homo sapiens (human)
iron ion bindingCytochrome P450 2B6Homo sapiens (human)
testosterone 16-alpha-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
heme bindingCytochrome P450 2B6Homo sapiens (human)
testosterone 16-beta-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 8,9 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 11,12 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
anandamide 14,15 epoxidase activityCytochrome P450 2B6Homo sapiens (human)
estrogen 2-hydroxylase activityCytochrome P450 2B6Homo sapiens (human)
oxidoreductase activity, acting on paired donors, with incorporation or reduction of molecular oxygen, reduced flavin or flavoprotein as one donor, and incorporation of one atom of oxygenCytochrome P450 2B6Homo sapiens (human)
arachidonic acid epoxygenase activityCytochrome P450 2B6Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Ceullar Components (26)

Processvia Protein(s)Taxonomy
basolateral plasma membraneBile salt export pumpHomo sapiens (human)
Golgi membraneBile salt export pumpHomo sapiens (human)
endosomeBile salt export pumpHomo sapiens (human)
plasma membraneBile salt export pumpHomo sapiens (human)
cell surfaceBile salt export pumpHomo sapiens (human)
apical plasma membraneBile salt export pumpHomo sapiens (human)
intercellular canaliculusBile salt export pumpHomo sapiens (human)
intracellular canaliculusBile salt export pumpHomo sapiens (human)
recycling endosomeBile salt export pumpHomo sapiens (human)
recycling endosome membraneBile salt export pumpHomo sapiens (human)
extracellular exosomeBile salt export pumpHomo sapiens (human)
membraneBile salt export pumpHomo sapiens (human)
outer membrane-bounded periplasmic spaceBeta-lactamaseEscherichia coli K-12
periplasmic spaceBeta-lactamaseEscherichia coli K-12
extracellular regionNeutrophil elastaseHomo sapiens (human)
extracellular spaceNeutrophil elastaseHomo sapiens (human)
cytoplasmNeutrophil elastaseHomo sapiens (human)
cytosolNeutrophil elastaseHomo sapiens (human)
cell surfaceNeutrophil elastaseHomo sapiens (human)
secretory granuleNeutrophil elastaseHomo sapiens (human)
azurophil granule lumenNeutrophil elastaseHomo sapiens (human)
specific granule lumenNeutrophil elastaseHomo sapiens (human)
phagocytic vesicleNeutrophil elastaseHomo sapiens (human)
collagen-containing extracellular matrixNeutrophil elastaseHomo sapiens (human)
extracellular exosomeNeutrophil elastaseHomo sapiens (human)
transcription repressor complexNeutrophil elastaseHomo sapiens (human)
extracellular spaceNeutrophil elastaseHomo sapiens (human)
endoplasmic reticulum membraneCytochrome P450 2B6Homo sapiens (human)
intracellular membrane-bounded organelleCytochrome P450 2B6Homo sapiens (human)
cytoplasmCytochrome P450 2B6Homo sapiens (human)
[Information is prepared from geneontology information from the June-17-2024 release]

Bioassays (302)

Assay IDTitleYearJournalArticle
AID1801066Steady-State Kinetics Assay from Article 10.1021/bi501197t: \\Detecting a quasi-stable imine species on the reaction pathway of SHV-1 u00DF-lactamase and 6u00DF-(hydroxymethyl)penicillanic acid sulfone.\\2015Biochemistry, Jan-27, Volume: 54, Issue:3
Detecting a quasi-stable imine species on the reaction pathway of SHV-1 β-lactamase and 6β-(hydroxymethyl)penicillanic acid sulfone.
AID1801074Steady State Kinetics from Article 10.1021/acs.biochem.5b00698: \\Kinetic and Structural Characterization of the Interaction of 6-Methylidene Penem 2 with the u00DF-Lactamase from Mycobacterium tuberculosis.\\2015Biochemistry, Sep-15, Volume: 54, Issue:36
Kinetic and Structural Characterization of the Interaction of 6-Methylidene Penem 2 with the β-Lactamase from Mycobacterium tuberculosis.
AID372637Inhibition of Escherichia coli DH5alpha CL1179 clone beta-lactamase TEM-152 after 10 mins2007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID584973Inhibition of beta-lactamase SHV-4 assessed as nitrocefin hydrolysis after 5 mins enzyme-compound preincubation2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID558547Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P305 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID50695The compound was tested for its inhibitory activity towards Class A TEM-1 beta-lactamase from Escherichia coli at 0.3 umol2002Bioorganic & medicinal chemistry letters, Mar-25, Volume: 12, Issue:6
Design, synthesis and bioactivity evaluation of tribactam beta lactamase inhibitors.
AID1559317Inhibition of bacterial CTX-M-15 using cefotaxime as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID558773Antibacterial activity against Campylobacter coli by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID563974Activity of Klebsiella pneumoniae 05-560 beta-lactamase IMP1 by spectrophotometry2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Characterization of a new metallo-beta-lactamase gene, bla(NDM-1), and a novel erythromycin esterase gene carried on a unique genetic structure in Klebsiella pneumoniae sequence type 14 from India.
AID727644Ratio of Kcat to Kinact for Beta-lactamase SHV-1 K234R protein mutant in Escherichia coli DH10B2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID496599Inhibition of Escherichia coli DH10B beta-lactamase KPC-2 assessed as residual activity at 25 to 200 uM after 72 hrs by diode array spectrophotometry2010Antimicrobial agents and chemotherapy, Feb, Volume: 54, Issue:2
Inhibitor resistance in the KPC-2 beta-lactamase, a preeminent property of this class A beta-lactamase.
AID495660Inhibition of Pseudomonas aeruginosa 51170 beta-lactamase BEL-12010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
BEL-2, an extended-spectrum beta-lactamase with increased activity toward expanded-spectrum cephalosporins in Pseudomonas aeruginosa.
AID351648Cmax in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID351640Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1.5 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID558551Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P790 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID558320Antibacterial activity against Campylobacter jejuni by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID43568Inhibitory activity against Escherichia coli TEM-3 Beta-lactamase1998Journal of medicinal chemistry, Oct-08, Volume: 41, Issue:21
Structure-based design of beta-lactamase inhibitors. 1. Synthesis and evaluation of bridged monobactams.
AID351434Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID584975Inhibition of beta-lactamase CTX-M-15 assessed as nitrocefin hydrolysis after 5 mins enzyme-compound preincubation2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID351635Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 6 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID558548Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P316 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID558318Antibacterial activity against Campylobacter jejuni by NCCLS agar doubling dilution method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID517929Antibacterial activity against beta-lactamase-positive ESBL-positive Escherichia coli assessed as decrease in zone of inhibition at 30 ug by disk diffusion method in presence of clavulanic acid2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Mutant prevention concentrations of four carbapenems against gram-negative rods.
AID567284Binding affinity to Acinetobacter baumannii ADC-33 beta-lactamase2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Extended-spectrum cephalosporinase in Acinetobacter baumannii.
AID351619Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 10 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID377032Antimicrobial activity against Enterobacter cloacae ATCC 13047 after 24 hrs by disk diffusion assay2005Journal of natural products, Jan, Volume: 68, Issue:1
Natural and synthetic 2,2-dimethylpyranocoumarins with antibacterial activity.
AID351436Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 2 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID52215Inhibitory activity against cephalosporinase from Proteus morganii TH-64 using cephalothin (40 uM) as a substrate; No inhibition1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(1,2,3-triazol-1-yl)methyl]-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide and related triazolyl derivatives.
AID297199Inhibition of Escherichia coli SHV12007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
4-Substituted trinems as broad spectrum beta-lactamase inhibitors: structure-based design, synthesis, and biological activity.
AID558552Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P1093 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID727651Inhibition of Beta-lactamase SHV-1 K234R protein mutant in Escherichia coli DH10B by Henri-Michaelis-Menten steady state equation analysis2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID351646Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 10 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID540209Volume of distribution at steady state in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID372627Inhibition of Escherichia coli DH5alpha beta-lactamase TEM-1582007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID444054Oral bioavailability in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID525577Inhibition of Beta-lactamase OXA-24/40 expressed in Escherichia coli BL21 (DE3) by nitrocefin hydrolysis assay2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
Penicillin sulfone inhibitors of class D beta-lactamases.
AID324363Inhibition of Acinetobacter johnsonii SCO12007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
Identification of the novel narrow-spectrum beta-lactamase SCO-1 in Acinetobacter spp. from Argentina.
AID543432Inhibition of Shigella sonnei UIH-1 beta-lactamase CTX-M-64 by spectrophotometry in presence of 100 uM nitrocefin2009Antimicrobial agents and chemotherapy, Jan, Volume: 53, Issue:1
Novel chimeric beta-lactamase CTX-M-64, a hybrid of CTX-M-15-like and CTX-M-14 beta-lactamases, found in a Shigella sonnei strain resistant to various oxyimino-cephalosporins, including ceftazidime.
AID43739Beta-lactamase inhibitory activity from Klebsiella pneumoniae A20634(TEM) and minimum protective concentration was reported1981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID351638Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 12 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID556339Inhibition of Salmonella enterica serotype Westhampton beta-lactamase CTX-M-532009Antimicrobial agents and chemotherapy, May, Volume: 53, Issue:5
Novel plasmid-encoded ceftazidime-hydrolyzing CTX-M-53 extended-spectrum beta-lactamase from Salmonella enterica serotypes Westhampton and Senftenberg.
AID1559320Inhibition of bacterial NDM-1 using cefepime as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID727645Ratio of Kcat to Kinact for wild type Beta-lactamase SHV-1 in Escherichia coli DH10B2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID558542Antibacterial activity against bla gene-negative and nitrocefin reaction-negative beta-lactamase harboring Campylobacter jejuni isolate P835 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID351214Cmax in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID558561Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter coli isolate P321 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID351651fAUC (0 to 24 hrs) in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID285275Inhibition of Escherichia coli BL21(DE3) beta-lactamase TEM292007Antimicrobial agents and chemotherapy, Apr, Volume: 51, Issue:4
Evolution of TEM-type enzymes: biochemical and genetic characterization of two new complex mutant TEM enzymes, TEM-151 and TEM-152, from a single patient.
AID572897Inhibition of Klebsiella pneumoniae Beta-lactamase SHV-12009Antimicrobial agents and chemotherapy, Feb, Volume: 53, Issue:2
In vitro activity of LK-157, a novel tricyclic carbapenem as broad-spectrum {beta}-lactamase inhibitor.
AID43117Minimum protective concentration used to protect the compound against Bacteroides fragilis A-22,695 beta-lactamase catalyzed hydrolysis1985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID548270Ratio of Ki for Klebsiella pneumoniae 1534 beta-lactamase KPC-2 T237A mutant to Ki for Klebsiella pneumoniae beta-lactamase KPC-2 T237S mutant by competitive assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Substrate selectivity and a novel role in inhibitor discrimination by residue 237 in the KPC-2 beta-lactamase.
AID351637Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 10 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID517930Antibacterial activity against beta-lactamase-positive ESBL-positive sKlebsiella pneumoniae assessed as decrease in zone of inhibition at 30 ug by disk diffusion method2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Mutant prevention concentrations of four carbapenems against gram-negative rods.
AID154308Inhibition of hydrolysis of nitrocefin after 5 min pre-incubation with P99 beta-lactamases (class C)2004Bioorganic & medicinal chemistry letters, May-17, Volume: 14, Issue:10
Design and synthesis of bridged gamma-lactams as analogues of beta-lactam antibiotics.
AID351221Half life of free unbound fraction in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID351645Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 8 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID519637Inhibition of Brachyspira pilosicoli beta-lactamase OXA-63 expressed in Escherichia coli BL21 (DE3) assessed as reduction in nitrocefin hydrolysis by spectrophotometry relative to oxacillin2008Antimicrobial agents and chemotherapy, Apr, Volume: 52, Issue:4
Genetic and biochemical characterization of OXA-63, a new class D beta-lactamase from Brachyspira pilosicoli BM4442.
AID584987Inhibition of beta-lactamase TEM-1 after 5 seconds incubation with nitrocefin substrate by spectrophotometry2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID372628Inhibition of Escherichia coli DH5alpha beta-lactamase TEM-122007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID374027Inhibition of Serratia fonticola UTAD54 SFC1 beta lactamase expressed in Escherichia coli BL21(DE3) by SDS-PAGE2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Biochemical Characterization of SFC-1, a class A carbapenem-hydrolyzing beta-lactamase.
AID351222Half life in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID444052Hepatic clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID44046Beta-lactamase inhibitory activity from Staphylococcus aureus A9606 and minimum protective concentration was reported1981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID585189Inhibition of Beta-lactamase GES-2 E104, N170 mutant preincubated for 5 mins before substrate addition using cephalothin substrate by spectrophotometry2010Antimicrobial agents and chemotherapy, Nov, Volume: 54, Issue:11
Comparative biochemical and computational study of the role of naturally occurring mutations at Ambler positions 104 and 170 in GES β-lactamases.
AID70245Compound was evaluated for minimum inhibitory concentration in the presence of amoxicillin against Escherichia coli A201111985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID1209456Inhibition of Sprague-Dawley rat Bsep expressed in plasma membrane vesicles of Sf21 cells assessed as inhibition of ATP-dependent [3H]taurocholate uptake2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
In vitro inhibition of the bile salt export pump correlates with risk of cholestatic drug-induced liver injury in humans.
AID351440Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 8 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID678718Metabolic stability in human liver microsomes assessed as high signal/noise ratio (S/N of >100) by measuring GSH adduct formation at 100 uM after 90 mins by HPLC-MS analysis2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID531314Ratio of Kcat to Km for Pseudomonas aeruginosa beta-lactamase VIM-7 by spectrophotometry2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Kinetic characterization of VIM-7, a divergent member of the VIM metallo-beta-lactamase family.
AID525576Inhibition of Beta-lactamase OXA-17 expressed in Escherichia coli BL21 (DE3) by nitrocefin hydrolysis assay2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
Penicillin sulfone inhibitors of class D beta-lactamases.
AID69961Compound alone was evaluated for minimum inhibitory concentration against Escherichia coli A201111985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID422882Antimicrobial activity against Acinetobacter baumannii-Acinetobacter calcoaceticus complex isolated from diabetic patient with calcaneal osteomyelitis by broth microdilution assay2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Development of colistin-dependent Acinetobacter baumannii-Acinetobacter calcoaceticus complex.
AID558558Antibacterial activity against bla gene-positive and nitrocefin reaction-negative beta-lactamase harboring Campylobacter jejuni isolate P1699 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID43582Inhibition constant (Ki) for TEM-1 beta-lactamase1988Journal of medicinal chemistry, Feb, Volume: 31, Issue:2
N-aryl 3-halogenated azetidin-2-ones and benzocarbacephems, inhibitors of beta-lactamases.
AID525580Inhibition of Beta-lactamase OXA-1 expressed in Escherichia coli BL21 (DE3) by nitrocefin hydrolysis assay2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
Penicillin sulfone inhibitors of class D beta-lactamases.
AID496594Ratio of Kcat to Km for Escherichia coli DH10B beta-lactamase KPC-22010Antimicrobial agents and chemotherapy, Feb, Volume: 54, Issue:2
Inhibitor resistance in the KPC-2 beta-lactamase, a preeminent property of this class A beta-lactamase.
AID351438Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 4 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID422500Inhibition of Carnobacterium divergens BM4489 penicillinase Cad-12008Antimicrobial agents and chemotherapy, Feb, Volume: 52, Issue:2
Genetic and biochemical characterization of CAD-1, a chromosomally encoded new class A penicillinase from Carnobacterium divergens.
AID558549Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P338 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID531317Activity of Escherichia coli beta-lactamase VIM-1 by spectrophotometry2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Kinetic characterization of VIM-7, a divergent member of the VIM metallo-beta-lactamase family.
AID558540Antibacterial activity against bla gene-positive and nitrocefin reaction-negative beta-lactamase harboring Campylobacter jejuni isolate NCTC 11168 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID558557Antibacterial activity against bla gene-positive and nitrocefin reaction-negative beta-lactamase harboring Campylobacter jejuni isolate P1698 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID374364Antimicrobial activity against Aeromonas caviae A324R expressing metallo-beta-lactamase IMP-19 by broth dilution method2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
First occurrence of an IMP metallo-beta-lactamase in Aeromonas caviae: IMP-19 in an isolate from France.
AID541855Antimicrobial activity against Escherichia coli ATCC 29522 by microdilution assay2009Antimicrobial agents and chemotherapy, Feb, Volume: 53, Issue:2
IncA/C plasmid-mediated florfenicol resistance in the catfish pathogen Edwardsiella ictaluri.
AID351632Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 2 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID1225760Inhibition of Escherichia coli recombinant CTX-M-15 assessed as substrate nitrocefin degradation preincubated for 10 mins followed by substrate addition measured every 10 secs for 10 mins by spectrophotometric analysis2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Discovery of a Cyclic Boronic Acid β-Lactamase Inhibitor (RPX7009) with Utility vs Class A Serine Carbapenemases.
AID727641Binding affinity to wild type Beta-lactamase SHV-1 in Escherichia coli DH10B assessed as change in secondary structure at 50 uM by circular dichroism analysis2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID1559319Inhibition of bacterial OXA-1 using nitrocefin as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID585188Inhibition of Beta-lactamase GES-7 K104, G170 mutant preincubated for 5 mins before substrate addition using cephalothin substrate by spectrophotometry2010Antimicrobial agents and chemotherapy, Nov, Volume: 54, Issue:11
Comparative biochemical and computational study of the role of naturally occurring mutations at Ambler positions 104 and 170 in GES β-lactamases.
AID444050Fraction unbound in human plasma2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID285272Inhibition of Escherichia coli BL21(DE3) beta-lactamase TEM1512007Antimicrobial agents and chemotherapy, Apr, Volume: 51, Issue:4
Evolution of TEM-type enzymes: biochemical and genetic characterization of two new complex mutant TEM enzymes, TEM-151 and TEM-152, from a single patient.
AID285273Inhibition of Escherichia coli BL21(DE3) beta-lactamase TEM1522007Antimicrobial agents and chemotherapy, Apr, Volume: 51, Issue:4
Evolution of TEM-type enzymes: biochemical and genetic characterization of two new complex mutant TEM enzymes, TEM-151 and TEM-152, from a single patient.
AID444055Fraction absorbed in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID351641Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 2 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID351656Protein binding in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID558543Antibacterial activity against bla gene-negative and nitrocefin reaction-negative beta-lactamase harboring Campylobacter jejuni isolate P850 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID285444Inhibition of Citrobacter gillenii CIP 106783 Beta-lactamase GIL1 expressed in Escherichia coli DH10B2007Antimicrobial agents and chemotherapy, Apr, Volume: 51, Issue:4
Chromosome-encoded narrow-spectrum Ambler class A beta-lactamase GIL-1 from Citrobacter gillenii.
AID44049Minimum protective concentration used to protect the compound against Staphylococcus aureus A9606 beta-lactamase catalyzed hydrolysis1985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID372633Ratio of IC50 for Escherichia coli CF0042 beta-lactamase TEM-35 to IC50 for Escherichia coli DH5alpha beta-lactamase TEM-1582007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID588211Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in humans2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID425653Renal clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID326273Inhibition of Escherichia coli beta-lactamase SCO12007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
SCO-1, a novel plasmid-mediated class A beta-lactamase with carbenicillinase characteristics from Escherichia coli.
AID351636Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 8 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID584974Inhibition of beta-lactamase KPC-2 assessed as nitrocefin hydrolysis after 5 mins enzyme-compound preincubation2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID351623Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 2 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID678722Covalent binding affinity to human liver microsomes assessed per mg of protein at 10 uM after 60 mins presence of NADPH2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID368519Inhibition of Escherichia coli CTX-M-152007Antimicrobial agents and chemotherapy, Sep, Volume: 51, Issue:9
Interactions of ceftobiprole with beta-lactamases from molecular classes A to D.
AID558545Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P285 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID422883Antimicrobial activity against 8 ug/ml colistin-subcultured Acinetobacter baumannii-Acinetobacter calcoaceticus complex isolated from diabetic patient with calcaneal osteomyelitis and bacteremia by broth microdilution assay2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
Development of colistin-dependent Acinetobacter baumannii-Acinetobacter calcoaceticus complex.
AID540211Fraction unbound in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID584991Activity of beta-lactamase TEM-1 by spectrophotometry2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID297198Inhibition of Escherichia coli TEM12007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
4-Substituted trinems as broad spectrum beta-lactamase inhibitors: structure-based design, synthesis, and biological activity.
AID44047Minimum protective concentration against beta-lactamase in Staphylococcus aureus (95 strain)1997Journal of medicinal chemistry, Oct-10, Volume: 40, Issue:21
Cephalosporin 3'-phloroglucide esters and 7-(phloroglucidamido) cephalosporins as novel antibacterial agents.
AID519751Inhibition of Klebsiella pneumoniae Beta-Lactamase SHV-722008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
The Lys234Arg substitution in the enzyme SHV-72 is a determinant for resistance to clavulanic acid inhibition.
AID43565Inhibitory activity against Beta-lactamase type OXA1 (penicillinase) from Escherichia coli OXA1 using ampicillin (40 uM) as a substrate1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(1,2,3-triazol-1-yl)methyl]-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide and related triazolyl derivatives.
AID511293Inhibition of Pseudomonas aeruginosa GES-13 beta lactamase2010Antimicrobial agents and chemotherapy, Mar, Volume: 54, Issue:3
GES-13, a beta-lactamase variant possessing Lys-104 and Asn-170 in Pseudomonas aeruginosa.
AID517928Antibacterial activity against beta-lactamase-positive ESBL-positive Escherichia coli assessed as decrease in zone of inhibition at 30 ug by disk diffusion method2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Mutant prevention concentrations of four carbapenems against gram-negative rods.
AID373218Inhibition of Bacillus clausii NR beta-lactamase BCL1 expressed in Escherichia coli BL21 (DE3)2007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
Molecular and biochemical characterization of the chromosome-encoded class A beta-lactamase BCL-1 from Bacillus clausii.
AID558319Antibacterial activity against Campylobacter coli by NCCLS agar doubling dilution method2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID50536In vitro inhibition of Citrobacter freundii 1982 growth.1998Journal of medicinal chemistry, Oct-08, Volume: 41, Issue:21
Structure-based design of beta-lactamase inhibitors. 1. Synthesis and evaluation of bridged monobactams.
AID351435Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1.5 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID678713Inhibition of human CYP2C9 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-methoxy-4-trifluoromethylcoumarin-3-acetic acid as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID351624Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 3 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID351642Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 3 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID374361Antimicrobial activity against Escherichia coli DH5alpha expressing pJDB2 containing Aeromonas caviae A324R metallo-beta-lactamase gene by broth dilution method2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
First occurrence of an IMP metallo-beta-lactamase in Aeromonas caviae: IMP-19 in an isolate from France.
AID69960Compound alone was evaluated for minimum inhibitory concentration against Escherichia coli A201071985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID584985Ratio of Inactivation rate constant for longer incubation time yield to Km for beta-lactamase TEM-1 by spectrophotometry2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID351627Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 8 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID332500Inhibition of Enterobacter cloacae P99 beta-lactamase assessed as inhibition of nitrocefin hydrolysis pre-incubated for 5 mins by microtiter plate assay1994Journal of natural products, May, Volume: 57, Issue:5
SB-202742, a novel beta-lactamase inhibitor isolated from Spondias mombin.
AID351625Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 4 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID1808873Inhibition beta lactamase PDC-1 in Pseudomonas aeruginosa PAO1 using nitrocefin as substrate measured by 96 well microtitre plate
AID727643Binding affinity to wild type Beta-lactamase SHV-1 in Escherichia coli DH10B assessed as melting temperature at 50 uM by circular dichroism analysis (Rvb = 54.2 degC)2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID377030Antimicrobial activity against Staphylococcus epidermidis ATCC 12228 after 24 hrs by disk diffusion assay2005Journal of natural products, Jan, Volume: 68, Issue:1
Natural and synthetic 2,2-dimethylpyranocoumarins with antibacterial activity.
AID1209457Unbound Cmax in human plasma2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
In vitro inhibition of the bile salt export pump correlates with risk of cholestatic drug-induced liver injury in humans.
AID425652Total body clearance in human2009Journal of medicinal chemistry, Aug-13, Volume: 52, Issue:15
Physicochemical determinants of human renal clearance.
AID332502Inhibition of Staphylococcus aureus Russell beta-lactamase assessed as inhibition of nitrocefin hydrolysis pre-incubated for 5 mins by microtiter plate assay1994Journal of natural products, May, Volume: 57, Issue:5
SB-202742, a novel beta-lactamase inhibitor isolated from Spondias mombin.
AID1625569Potentiation of meropenem-induced bactericidal activity against wild-type replicating Mycobacterium tuberculosis H37Rv assessed as decrease in MIC90 relative to control2016Journal of medicinal chemistry, 07-14, Volume: 59, Issue:13
Novel Cephalosporins Selectively Active on Nonreplicating Mycobacterium tuberculosis.
AID1225759Inhibition of Escherichia coli recombinant KPC-2 assessed as substrate nitrocefin degradation preincubated for 10 mins followed by substrate addition measured every 10 secs for 10 mins by spectrophotometric analysis2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Discovery of a Cyclic Boronic Acid β-Lactamase Inhibitor (RPX7009) with Utility vs Class A Serine Carbapenemases.
AID377031Antimicrobial activity against Pseudomonas aeruginosa ATCC 27853 after 24 hrs by disk diffusion assay2005Journal of natural products, Jan, Volume: 68, Issue:1
Natural and synthetic 2,2-dimethylpyranocoumarins with antibacterial activity.
AID326269Inhibition of Escherichia coli TEM12007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
SCO-1, a novel plasmid-mediated class A beta-lactamase with carbenicillinase characteristics from Escherichia coli.
AID351622Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1.5 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID588212Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID444051Total clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID351639Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID572898Inhibition of Enterobacter cloacae Beta-lactamase AmpC2009Antimicrobial agents and chemotherapy, Feb, Volume: 53, Issue:2
In vitro activity of LK-157, a novel tricyclic carbapenem as broad-spectrum {beta}-lactamase inhibitor.
AID585192Inhibition of Beta-lactamase GES-13 K104, N170 mutant preincubated for 5 mins before substrate addition using cephalothin substrate by spectrophotometry2010Antimicrobial agents and chemotherapy, Nov, Volume: 54, Issue:11
Comparative biochemical and computational study of the role of naturally occurring mutations at Ambler positions 104 and 170 in GES β-lactamases.
AID351643Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 4 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID563972Activity of Klebsiella pneumoniae 05-560 beta-lactamase NDM-1 by spectrophotometry2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Characterization of a new metallo-beta-lactamase gene, bla(NDM-1), and a novel erythromycin esterase gene carried on a unique genetic structure in Klebsiella pneumoniae sequence type 14 from India.
AID588213Literature-mined compound from Fourches et al multi-species drug-induced liver injury (DILI) dataset, effect in non-rodents2010Chemical research in toxicology, Jan, Volume: 23, Issue:1
Cheminformatics analysis of assertions mined from literature that describe drug-induced liver injury in different species.
AID374366Antimicrobial activity against Escherichia coli DH5alpha by broth dilution method2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
First occurrence of an IMP metallo-beta-lactamase in Aeromonas caviae: IMP-19 in an isolate from France.
AID70244Compound was evaluated for minimum inhibitory concentration in the presence of amoxicillin against Escherichia coli A201071985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID727648Antimicrobial activity against Escherichia coli DH10B expressing Beta-lactamase SHV K234R mutant by CLSI agar dilution method in presence of ampicillin2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID584976Inhibition of beta-lactamase TEM- 1 assessed as nitrocefin hydrolysis after 5 mins enzyme-compound preincubation2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID727649Antimicrobial activity against Escherichia coli DH10B expressing wild type Beta-lactamase SHV1 gene by CLSI agar dilution method in presence of ampicillin2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID351630Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID200260Minimum inhibitory activity against Staphylococcus aureus A96061981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID351633Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 3 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID332498Inhibition of Escherichia coli JT4 beta-lactamase TEM1 assessed as inhibition of nitrocefin hydrolysis preincubated for 5 mins by microtiter plate assay1994Journal of natural products, May, Volume: 57, Issue:5
SB-202742, a novel beta-lactamase inhibitor isolated from Spondias mombin.
AID727647Antimicrobial activity against Escherichia coli DH10B expressing Beta-lactamase SHV K234A mutant by CLSI agar dilution method in presence of ampicillin2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID558546Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P286 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID1559308Inhibition of bacterial KPC-2 using imipenem as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID517931Antibacterial activity against beta-lactamase-positive ESBL-positive Klebsiella pneumoniae assessed as decrease in zone of inhibition at 30 ug by disk diffusion method in presence of clavulanic acid2010Antimicrobial agents and chemotherapy, Jun, Volume: 54, Issue:6
Mutant prevention concentrations of four carbapenems against gram-negative rods.
AID377029Antimicrobial activity against Staphylococcus aureus ATCC 25923 after 24 hrs by disk diffusion assay2005Journal of natural products, Jan, Volume: 68, Issue:1
Natural and synthetic 2,2-dimethylpyranocoumarins with antibacterial activity.
AID558550Antibacterial activity against Campylobacter jejuni isolate P338 harboring blaOXA-61::cat gene by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID727640Binding affinity to Beta-lactamase SHV-1 K234R protein mutant in Escherichia coli DH10B assessed as change in secondary structure at 50 uM by circular dichroism analysis2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID351620Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 12 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID572899Inhibition of Beta-lactamase TEM-12009Antimicrobial agents and chemotherapy, Feb, Volume: 53, Issue:2
In vitro activity of LK-157, a novel tricyclic carbapenem as broad-spectrum {beta}-lactamase inhibitor.
AID43098Beta-lactamase inhibitory activity from Bacillus fragilis A-22,695 and minimum protective concentration was reported1981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID351626Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 6 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID555231Inhibition of Acinetobacter genomosp. 3 isolate 195 ADC-182009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Genetic variability among ampC genes from acinetobacter genomic species 3.
AID332497Inhibition of Escherichia coli K-12 beta-lactamase OXA1 assessed as inhibition of nitrocefin hydrolysis pre-incubated for 5 mins by microtiter plate assay1994Journal of natural products, May, Volume: 57, Issue:5
SB-202742, a novel beta-lactamase inhibitor isolated from Spondias mombin.
AID584983Inhibition of beta-lactamase TEM-1 assessed as inactivation rate constant for longer incubation time yield of enzyme by spectrophotometry2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID1225764Inhibition of Escherichia coli recombinant CMY-2 assessed as substrate nitrocefin degradation preincubated for 10 mins followed by substrate addition measured every 10 secs for 10 mins by spectrophotometric analysis2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Discovery of a Cyclic Boronic Acid β-Lactamase Inhibitor (RPX7009) with Utility vs Class A Serine Carbapenemases.
AID207623Compound alone was evaluated for minimum inhibitory concentration against Staphylococcus aureus A150331985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID377035Antimicrobial activity against Klebsiella pneumoniae ATCC 13883 after 24 hrs by disk diffusion assay2005Journal of natural products, Jan, Volume: 68, Issue:1
Natural and synthetic 2,2-dimethylpyranocoumarins with antibacterial activity.
AID374365Antimicrobial activity against Escherichia coli DH5alpha expressing pIP19 containing Aeromonas caviae A324R metallo-beta-lactamase blaIMP-19 gene by broth dilution method2007Antimicrobial agents and chemotherapy, Dec, Volume: 51, Issue:12
First occurrence of an IMP metallo-beta-lactamase in Aeromonas caviae: IMP-19 in an isolate from France.
AID351634Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 4 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID678712Inhibition of human CYP1A2 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using ethoxyresorufin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID1559318Inhibition of bacterial CMY-2 using nitrocefin as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID43913Inhibitory activity against Penicillinase from Staphylococcus aureus TH-14 using piperacillin (40 uM) as a substrate1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(1,2,3-triazol-1-yl)methyl]-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide and related triazolyl derivatives.
AID560135Inhibition of recombinant beta-lactamase RTG4 expressed in Escherichia coli TOP10 by nitrocefin hydrolysis assay2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Genetic and biochemical characterization of the first extended-spectrum CARB-type beta-lactamase, RTG-4, from Acinetobacter baumannii.
AID285276Inhibition of Escherichia coli BL21(DE3) beta-lactamase TEM362007Antimicrobial agents and chemotherapy, Apr, Volume: 51, Issue:4
Evolution of TEM-type enzymes: biochemical and genetic characterization of two new complex mutant TEM enzymes, TEM-151 and TEM-152, from a single patient.
AID495800Inhibition of Pseudomonas fluorescens PF-1 beta-lactamase BIC-1 expressed in Escherichia coli DH10B carrying pSau12010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
Novel ambler class A carbapenem-hydrolyzing beta-lactamase from a Pseudomonas fluorescens isolate from the Seine River, Paris, France.
AID558556Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P1730 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID372638Inhibition of Escherichia coli DH10B beta-lactamase TEM-121 after 10 mins2007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID351631Unbound drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1.5 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID444058Volume of distribution at steady state in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID1559310Inhibition of bacterial OXA-48 using nitrocefin as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID548269Ratio of Ki for Klebsiella pneumoniae 1534 beta-lactamase KPC-2 T237S mutant to Ki for Klebsiella pneumoniae wild type beta-lactamase KPC-2 by competitive assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Substrate selectivity and a novel role in inhibitor discrimination by residue 237 in the KPC-2 beta-lactamase.
AID200259Minimum inhibitory activity against Staphylococcus aureus A203091981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID372632Ratio of IC50 for Escherichia coli DH5alpha beta-lactamase TEM-158 to IC50 for Escherichia coli DH5alpha beta-lactamase TEM-12007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID66646Inhibitory concentration which is required to cause 50% inhibition of human leukocyte elastase (HLE) enzyme1990Journal of medicinal chemistry, Sep, Volume: 33, Issue:9
Inhibition of human leukocyte elastase. 1. Inhibition by C-7-substituted cephalosporin tert-butyl esters.
AID540213Half life in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID351209fTmax in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID372629Inhibition of Escherichia coli CF0042 beta-lactamase TEM-352007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID727652Inhibition of wild type Beta-lactamase SHV-1 in Escherichia coli DH10B by Henri-Michaelis-Menten steady state equation analysis2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID558555Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P1650 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID727650Antimicrobial activity against Escherichia coli DH10B by CLSI agar dilution method in presence of ampicillin2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID326275Inhibition of Escherichia coli K12 TEM12007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
SCO-1, a novel plasmid-mediated class A beta-lactamase with carbenicillinase characteristics from Escherichia coli.
AID285274Inhibition of Escherichia coli BL21(DE3) beta-lactamase TEM282007Antimicrobial agents and chemotherapy, Apr, Volume: 51, Issue:4
Evolution of TEM-type enzymes: biochemical and genetic characterization of two new complex mutant TEM enzymes, TEM-151 and TEM-152, from a single patient.
AID555229Inhibition of Acinetobacter genomosp. 3 isolate 65 ADC-142009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Genetic variability among ampC genes from acinetobacter genomic species 3.
AID560136Inhibition of recombinant beta-lactamase RTG3 expressed in Escherichia coli TOP10 by nitrocefin hydrolysis assay2009Antimicrobial agents and chemotherapy, Jul, Volume: 53, Issue:7
Genetic and biochemical characterization of the first extended-spectrum CARB-type beta-lactamase, RTG-4, from Acinetobacter baumannii.
AID351649fCmax in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID558560Antibacterial activity against bla gene-negative and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P854 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID394491Inhibition of Escherichia coli beta-lactamase ACC42007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
Plasmid-encoded ACC-4, an extended-spectrum cephalosporinase variant from Escherichia coli.
AID584977Inhibition of Enterobacter cloacae beta-lactamase P99 assessed as nitrocefin hydrolysis after 5 mins enzyme-compound preincubation2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID207800Compound was evaluated for minimum inhibitory concentration in the presence of amoxicillin against Staphylococcus aureus A150331985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID540210Clearance in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID548267Inhibition of Klebsiella pneumoniae 1534 beta-lactamase KPC-2 T237S mutant by competitive assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Substrate selectivity and a novel role in inhibitor discrimination by residue 237 in the KPC-2 beta-lactamase.
AID1559321Inhibition of bacterial IMP-1 using nitrocefin as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID311524Oral bioavailability in human2007Bioorganic & medicinal chemistry, Dec-15, Volume: 15, Issue:24
Hologram QSAR model for the prediction of human oral bioavailability.
AID678714Inhibition of human CYP2C19 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 3-butyryl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID558554Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P1618 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID69324In vitro inhibition of Escherichia coli TEM-3 growth.1998Journal of medicinal chemistry, Oct-08, Volume: 41, Issue:21
Structure-based design of beta-lactamase inhibitors. 1. Synthesis and evaluation of bridged monobactams.
AID541857Antimicrobial activity against Escherichia coli ATCC 29522 carrying Edwardsiella ictaluri pM07-1 by microdilution assay2009Antimicrobial agents and chemotherapy, Feb, Volume: 53, Issue:2
IncA/C plasmid-mediated florfenicol resistance in the catfish pathogen Edwardsiella ictaluri.
AID297200Inhibition of Enterobacter cloacae AmpC2007Journal of medicinal chemistry, Aug-23, Volume: 50, Issue:17
4-Substituted trinems as broad spectrum beta-lactamase inhibitors: structure-based design, synthesis, and biological activity.
AID444053Renal clearance in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID531315Activity of Pseudomonas aeruginosa beta-lactamase VIM-2 by spectrophotometry2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Kinetic characterization of VIM-7, a divergent member of the VIM metallo-beta-lactamase family.
AID43566Inhibitory activity against Beta-lactamase type TEM2 (penicillinase) from Escherichia coli TEM2 using penicillin G (40 uM) as a substrate1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(1,2,3-triazol-1-yl)methyl]-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide and related triazolyl derivatives.
AID555230Inhibition of Acinetobacter genomosp. 3 isolate 103 ADC-162009Antimicrobial agents and chemotherapy, Mar, Volume: 53, Issue:3
Genetic variability among ampC genes from acinetobacter genomic species 3.
AID351644Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 6 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID548268Inhibition of Klebsiella pneumoniae 1534 beta-lactamase KPC-2 T237A mutant by competitive assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Substrate selectivity and a novel role in inhibitor discrimination by residue 237 in the KPC-2 beta-lactamase.
AID540212Mean residence time in human after iv administration2008Drug metabolism and disposition: the biological fate of chemicals, Jul, Volume: 36, Issue:7
Trend analysis of a database of intravenous pharmacokinetic parameters in humans for 670 drug compounds.
AID351216Tmax in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID43885Inhibitory concentration was evaluated as concentration required for 50% inhibition of Pseudomonas aeruginosa 18SH Beta-lactamase1998Journal of medicinal chemistry, Oct-08, Volume: 41, Issue:21
Structure-based design of beta-lactamase inhibitors. 1. Synthesis and evaluation of bridged monobactams.
AID52216Inhibitory activity against cephalosporinase from Proteus vulgaris TH-147 using cephalexin (40 uM) as a substrate1987Journal of medicinal chemistry, Aug, Volume: 30, Issue:8
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(1,2,3-triazol-1-yl)methyl]-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide and related triazolyl derivatives.
AID351437Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 3 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID584978Inhibition of Pseudomonas aeruginosa beta-lactamase AmpC assessed as nitrocefin hydrolysis after 5 mins enzyme-compound preincubation2010Antimicrobial agents and chemotherapy, Dec, Volume: 54, Issue:12
Mechanistic studies of the inactivation of TEM-1 and P99 by NXL104, a novel non-beta-lactam beta-lactamase inhibitor.
AID1225762Inhibition of Escherichia coli recombinant TEM-10 assessed as substrate nitrocefin degradation preincubated for 10 mins followed by substrate addition measured every 10 secs for 10 mins by spectrophotometric analysis2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Discovery of a Cyclic Boronic Acid β-Lactamase Inhibitor (RPX7009) with Utility vs Class A Serine Carbapenemases.
AID332499Inhibition of Pseudomonas aeruginosa A beta-lactamase assessed as inhibition of nitrocefin hydrolysis preincubated for 5 mins by microtiter plate assay1994Journal of natural products, May, Volume: 57, Issue:5
SB-202742, a novel beta-lactamase inhibitor isolated from Spondias mombin.
AID519750Inhibition of Klebsiella pneumoniae Beta-Lactamase SHV-12008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
The Lys234Arg substitution in the enzyme SHV-72 is a determinant for resistance to clavulanic acid inhibition.
AID351628Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 10 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID585187Inhibition of Beta-lactamase GES-1 E104, G170 mutant preincubated for 5 mins before substrate addition using cephalothin substrate by spectrophotometry2010Antimicrobial agents and chemotherapy, Nov, Volume: 54, Issue:11
Comparative biochemical and computational study of the role of naturally occurring mutations at Ambler positions 104 and 170 in GES β-lactamases.
AID727642Binding affinity to Beta-lactamase SHV-1 K234R protein mutant in Escherichia coli DH10B assessed as melting temperature at 50 uM by circular dichroism analysis (Rvb = 48.2 degC)2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID209010Time dependent inhibition of hydrolysis of nitrocefin after 5 min pre-incubation with TEM-1 beta-lactamase (class 1)2004Bioorganic & medicinal chemistry letters, May-17, Volume: 14, Issue:10
Design and synthesis of bridged gamma-lactams as analogues of beta-lactam antibiotics.
AID531316Ratio of Kcat to Km for Pseudomonas aeruginosa beta-lactamase VIM-2 by spectrophotometry2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Kinetic characterization of VIM-7, a divergent member of the VIM metallo-beta-lactamase family.
AID43893Minimum protective concentration against beta-lactamase Pseudomonas aeruginosa (18S-H strain)1997Journal of medicinal chemistry, Oct-10, Volume: 40, Issue:21
Cephalosporin 3'-phloroglucide esters and 7-(phloroglucidamido) cephalosporins as novel antibacterial agents.
AID678717Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 7-benzyloxyquinoline as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID558562Antibacterial activity against bla-positive and beta-lactamase-weakly positive Campylobacter coli isolate P1627 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID558553Antibacterial activity against Campylobacter jejuni isolate P1093 harboring blaOXA-61::cat gene by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID351219fAUC (0 to 24 hrs) in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID1559316Inhibition of bacterial SHV-5 using cefotaxime as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID50709The compound was tested for its inhibitory activity towards Class C beta-lactamase from Enterobacter cloacae 908R at 0.8 umol concentration2002Bioorganic & medicinal chemistry letters, Mar-25, Volume: 12, Issue:6
Design, synthesis and bioactivity evaluation of tribactam beta lactamase inhibitors.
AID525578Inhibition of Beta-lactamase OXA-14 expressed in Escherichia coli BL21 (DE3) by nitrocefin hydrolysis assay2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
Penicillin sulfone inhibitors of class D beta-lactamases.
AID372639Inhibition of Escherichia coli TO799 beta-lactamase TEM-125 after 10 mins2007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID351629Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 12 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID44219Inhibitory activity at beta-lactamase I from Bacillus cereus expressed as percent inhibition of beta-lactam hydrolysis at a concentration of 10.0 umol/L2002Bioorganic & medicinal chemistry letters, Mar-25, Volume: 12, Issue:6
Design, synthesis and bioactivity evaluation of tribactam beta lactamase inhibitors.
AID519985Inhibition of Klebsiella pneumoniae Beta-Lactamase SHV-552008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Biochemical characterization of SHV-55, an extended-spectrum class A beta-lactamase from Klebsiella pneumoniae.
AID64067Minimum inhibitory activity against Escherichia coli A96751981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID326274Inhibition of Escherichia coli K12 CARB12007Antimicrobial agents and chemotherapy, Jun, Volume: 51, Issue:6
SCO-1, a novel plasmid-mediated class A beta-lactamase with carbenicillinase characteristics from Escherichia coli.
AID588220Literature-mined public compounds from Kruhlak et al phospholipidosis modelling dataset2008Toxicology mechanisms and methods, , Volume: 18, Issue:2-3
Development of a phospholipidosis database and predictive quantitative structure-activity relationship (QSAR) models.
AID1225761Inhibition of Escherichia coli recombinant SHV-12 assessed as substrate nitrocefin degradation preincubated for 10 mins followed by substrate addition measured every 10 secs for 10 mins by spectrophotometric analysis2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Discovery of a Cyclic Boronic Acid β-Lactamase Inhibitor (RPX7009) with Utility vs Class A Serine Carbapenemases.
AID558559Antibacterial activity against bla gene-negative and nitrocefin reaction-positive beta-lactamase harboring Campylobacter jejuni isolate P843 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID585191Inhibition of Beta-lactamase GES-6 K104, S170 mutant preincubated for 5 mins before substrate addition using cephalothin substrate by spectrophotometry2010Antimicrobial agents and chemotherapy, Nov, Volume: 54, Issue:11
Comparative biochemical and computational study of the role of naturally occurring mutations at Ambler positions 104 and 170 in GES β-lactamases.
AID531313Activity of Pseudomonas aeruginosa beta-lactamase VIM-7 by spectrophotometry2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Kinetic characterization of VIM-7, a divergent member of the VIM metallo-beta-lactamase family.
AID43741Minimum protective concentration used to protect the compound against Klebsiella pneumoniae A20634 beta-lactamase catalyzed hydrolysis1985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID44220Inhibitory activity at beta-lactamase I from Bacillus cereus expressed as percent inhibition of beta-lactam hydrolysis at a concentration of 100.0 umol/L2002Bioorganic & medicinal chemistry letters, Mar-25, Volume: 12, Issue:6
Design, synthesis and bioactivity evaluation of tribactam beta lactamase inhibitors.
AID558544Antibacterial activity against bla gene-negative and nitrocefin reaction-negative beta-lactamase harboring Campylobacter jejuni isolate P1962 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID495801Inhibition of carbapenem-resistant Klebsiella pneumoniae carbepenem-hydrolyzing beta-lactamase KPC-12010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
Novel ambler class A carbapenem-hydrolyzing beta-lactamase from a Pseudomonas fluorescens isolate from the Seine River, Paris, France.
AID1559311Inhibition of bacterial VIM-2 using nitrocefin as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID1209455Inhibition of human BSEP expressed in plasma membrane vesicles of Sf21 cells assessed as inhibition of ATP-dependent [3H]taurocholate uptake2012Drug metabolism and disposition: the biological fate of chemicals, Jan, Volume: 40, Issue:1
In vitro inhibition of the bile salt export pump correlates with risk of cholestatic drug-induced liver injury in humans.
AID285277Inhibition of Escherichia coli BL21(DE3) beta-lactamase TEM12007Antimicrobial agents and chemotherapy, Apr, Volume: 51, Issue:4
Evolution of TEM-type enzymes: biochemical and genetic characterization of two new complex mutant TEM enzymes, TEM-151 and TEM-152, from a single patient.
AID377033Antimicrobial activity against Escherichia coli ATCC 25922 after 24 hrs by disk diffusion assay2005Journal of natural products, Jan, Volume: 68, Issue:1
Natural and synthetic 2,2-dimethylpyranocoumarins with antibacterial activity.
AID496597Ratio of Kinact to Km for Escherichia coli DH10B beta-lactamase KPC-22010Antimicrobial agents and chemotherapy, Feb, Volume: 54, Issue:2
Inhibitor resistance in the KPC-2 beta-lactamase, a preeminent property of this class A beta-lactamase.
AID548266Inhibition of Klebsiella pneumoniae 1534 beta-lactamase KPC-2 by competitive assay2010Antimicrobial agents and chemotherapy, Jul, Volume: 54, Issue:7
Substrate selectivity and a novel role in inhibitor discrimination by residue 237 in the KPC-2 beta-lactamase.
AID525579Inhibition of Beta-lactamase OXA-10 expressed in Escherichia coli BL21 (DE3) by nitrocefin hydrolysis assay2010Antimicrobial agents and chemotherapy, Apr, Volume: 54, Issue:4
Penicillin sulfone inhibitors of class D beta-lactamases.
AID496596Ratio of Kcat to Kinact for Escherichia coli DH10B beta-lactamase KPC-22010Antimicrobial agents and chemotherapy, Feb, Volume: 54, Issue:2
Inhibitor resistance in the KPC-2 beta-lactamase, a preeminent property of this class A beta-lactamase.
AID332501Inhibition of Proteus mirabilis C889 beta-lactamase assessed as inhibition of nitrocefin hydrolysis preincubated for 5 mins by microtiter plate assay1994Journal of natural products, May, Volume: 57, Issue:5
SB-202742, a novel beta-lactamase inhibitor isolated from Spondias mombin.
AID351647Unbound drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 12 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID495659Inhibition of Pseudomonas aeruginosa 531 beta-lactamase BEL-22010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
BEL-2, an extended-spectrum beta-lactamase with increased activity toward expanded-spectrum cephalosporins in Pseudomonas aeruginosa.
AID558563Antibacterial activity against bla gene-positive and nitrocefin reaction-positive beta-lactamase harboring Campylobacter coli isolate P1826 by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID372631Ratio of IC50 for Escherichia coli DH5alpha beta-lactamase TEM-158 to IC50 for Escherichia coli DH5alpha beta-lactamase TEM-122007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID567285Binding affinity to Acinetobacter baumannii ADC-11 beta-lactamase2010Antimicrobial agents and chemotherapy, Aug, Volume: 54, Issue:8
Extended-spectrum cephalosporinase in Acinetobacter baumannii.
AID585190Inhibition of Beta-lactamase GES-5 E104, S170 mutant preincubated for 5 mins before substrate addition using cephalothin substrate by spectrophotometry2010Antimicrobial agents and chemotherapy, Nov, Volume: 54, Issue:11
Comparative biochemical and computational study of the role of naturally occurring mutations at Ambler positions 104 and 170 in GES β-lactamases.
AID444057Fraction escaping hepatic elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID678716Inhibition of human CYP3A4 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using diethoxyfluorescein as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID19101Half life at a pH of 9 and temperature 37 degree2004Bioorganic & medicinal chemistry letters, May-17, Volume: 14, Issue:10
Design and synthesis of bridged gamma-lactams as analogues of beta-lactam antibiotics.
AID351220AUC (0 to 24 hrs) in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID162939In vitro inhibition of Pseudomonas aeruginosa 18SH growth.1998Journal of medicinal chemistry, Oct-08, Volume: 41, Issue:21
Structure-based design of beta-lactamase inhibitors. 1. Synthesis and evaluation of bridged monobactams.
AID531318Ratio of Kcat to Km for Escherichia coli beta-lactamase VIM-1 by spectrophotometry2008Antimicrobial agents and chemotherapy, Aug, Volume: 52, Issue:8
Kinetic characterization of VIM-7, a divergent member of the VIM metallo-beta-lactamase family.
AID351215fCmax in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID207624Compound alone was evaluated for minimum inhibitory concentration against Staphylococcus aureus A96061985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID519984Inhibition of Klebsiella pneumoniae Beta-Lactamase SHV-12008Antimicrobial agents and chemotherapy, May, Volume: 52, Issue:5
Biochemical characterization of SHV-55, an extended-spectrum class A beta-lactamase from Klebsiella pneumoniae.
AID200258Minimum inhibitory activity against Staphylococcus aureus A150911981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID372630Inhibition of Escherichia coli DH5alpha beta-lactamase TEM-12007Antimicrobial agents and chemotherapy, Nov, Volume: 51, Issue:11
TEM-158 (CMT-9), a new member of the CMT-type extended-spectrum beta-lactamases.
AID558541Antibacterial activity against Campylobacter jejuni isolate P270 harboring blaOXA-61::cat gene by NCCLS agar doubling dilution method in presence of clavulanic acid2009Antimicrobial agents and chemotherapy, Aug, Volume: 53, Issue:8
Beta-lactamase-mediated beta-lactam resistance in Campylobacter species: prevalence of Cj0299 (bla OXA-61) and evidence for a novel beta-Lactamase in C. jejuni.
AID727646Antimicrobial activity against Escherichia coli DH10B expressing Beta-lactamase SHV K234X mutant by CLSI agar dilution method in presence of ampicillin2013Journal of medicinal chemistry, Feb-14, Volume: 56, Issue:3
Design and exploration of novel boronic acid inhibitors reveals important interactions with a clavulanic acid-resistant sulfhydryl-variable (SHV) β-lactamase.
AID678715Inhibition of human CYP2D6 assessed as ratio of IC50 in absence of NADPH to IC50 for presence of NADPH using 4-methylaminoethyl-7-methoxycoumarin as substrate after 30 mins2012Chemical research in toxicology, Oct-15, Volume: 25, Issue:10
Preclinical strategy to reduce clinical hepatotoxicity using in vitro bioactivation data for >200 compounds.
AID332496Inhibition of Escherichia coli K-12 beta-lactamase PSE-4 assessed as inhibition of nitrocefin hydrolysis preincubated for 5 mins by microtiter plate assay1994Journal of natural products, May, Volume: 57, Issue:5
SB-202742, a novel beta-lactamase inhibitor isolated from Spondias mombin.
AID563976Activity of Klebsiella pneumoniae 05-560 beta-lactamase VIM2 by spectrophotometry2009Antimicrobial agents and chemotherapy, Dec, Volume: 53, Issue:12
Characterization of a new metallo-beta-lactamase gene, bla(NDM-1), and a novel erythromycin esterase gene carried on a unique genetic structure in Klebsiella pneumoniae sequence type 14 from India.
AID444056Fraction escaping gut-wall elimination in human2010Journal of medicinal chemistry, Feb-11, Volume: 53, Issue:3
Physicochemical space for optimum oral bioavailability: contribution of human intestinal absorption and first-pass elimination.
AID495653Inhibition of Pseudomonas luteola LAM Beta-lactamase LUT-12010Antimicrobial agents and chemotherapy, Jan, Volume: 54, Issue:1
Molecular and biochemical characterization of the natural chromosome-encoded class A beta-lactamase from Pseudomonas luteola.
AID1559309Inhibition of bacterial AmpC using nitrocefin as substrate preincubated for 15 mins followed by susbtrate addition and measured after 10 mins by spectrophotometric method2020Journal of medicinal chemistry, 03-26, Volume: 63, Issue:6
Discovery of Taniborbactam (VNRX-5133): A Broad-Spectrum Serine- and Metallo-β-lactamase Inhibitor for Carbapenem-Resistant Bacterial Infections.
AID351439Drug concentration in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 6 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID1225763Inhibition of Escherichia coli recombinant P99 assessed as substrate nitrocefin degradation preincubated for 10 mins followed by substrate addition measured every 10 secs for 10 mins by spectrophotometric analysis2015Journal of medicinal chemistry, May-14, Volume: 58, Issue:9
Discovery of a Cyclic Boronic Acid β-Lactamase Inhibitor (RPX7009) with Utility vs Class A Serine Carbapenemases.
AID541856Antimicrobial activity against florfenicol-resistant Edwardsiella ictaluri M07-1 by microdilution assay2009Antimicrobial agents and chemotherapy, Feb, Volume: 53, Issue:2
IncA/C plasmid-mediated florfenicol resistance in the catfish pathogen Edwardsiella ictaluri.
AID64066Minimum inhibitory activity against Escherichia coli A212231981Journal of medicinal chemistry, Dec, Volume: 24, Issue:12
Synthesis and beta-lactamase inhibitory properties of 2 beta-(chloromethyl)-2 alpha-methylpenam-3 alpha-carboxylic acid 1,1-dioxide.
AID422501Ratio of IC50 for beta-lactamase TEM-1 over IC50 for Carnobacterium divergens BM4489 penicillinase Cad-12008Antimicrobial agents and chemotherapy, Feb, Volume: 52, Issue:2
Genetic and biochemical characterization of CAD-1, a chromosomally encoded new class A penicillinase from Carnobacterium divergens.
AID351650AUC (0 to 24 hrs) in beta lactamase-positive Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 48 hrs2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
AID207801Compound was evaluated for minimum inhibitory concentration in the presence of amoxicillin against Staphylococcus aureus A96061985Journal of medicinal chemistry, Apr, Volume: 28, Issue:4
Synthesis and beta-lactamase inhibitory properties of 2 beta-[(acyloxy)methyl]-2-methylpenam-3 alpha-carboxylic acid 1,1-dioxides.
AID44218Inhibitory activity at beta-lactamase I from Bacillus cereus expressed as percent inhibition of beta-lactam hydrolysis at a concentration of 1.0 umol/L2002Bioorganic & medicinal chemistry letters, Mar-25, Volume: 12, Issue:6
Design, synthesis and bioactivity evaluation of tribactam beta lactamase inhibitors.
AID351621Drug concentration in beta lactamase-negative Haemophilus influenzae pharmacokinetic simulation model dosed as amoxicillin-clavulanic acid at simulated human serum concentration of 2000/125 mg, po bid after 1 hr2007Antimicrobial agents and chemotherapy, Oct, Volume: 51, Issue:10
influence of TEM-1 beta-lactamase on the pharmacodynamic activity of simulated total versus free-drug serum concentrations of cefditoren (400 milligrams) versus amoxicillin-clavulanic acid (2,000/125 milligrams) against Haemophilus influenzae strains exhi
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (1,689)

TimeframeStudies, This Drug (%)All Drugs %
pre-1990366 (21.67)18.7374
1990's445 (26.35)18.2507
2000's412 (24.39)29.6817
2010's354 (20.96)24.3611
2020's112 (6.63)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials212 (11.77%)5.53%
Reviews112 (6.22%)6.00%
Case Studies200 (11.10%)4.05%
Observational10 (0.56%)0.25%
Other1,267 (70.35%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (172)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
Pharmacokinetics and Safety of Ticarcillin-clavulanate in Infants [NCT01229046]Phase 10 participants (Actual)Interventional2010-09-30Withdrawn(stopped due to No enrollment occured. Subjects will be enrolled under a new protocol.)
A Randomized, Double-Blind, Placebo-Controlled Phase 2a Pilot Study to Assess the Efficacy and Safety of Clavulanic Acid vs. Placebo for the Treatment of Cocaine Use Disorder [NCT05562349]Phase 265 participants (Anticipated)Interventional2023-05-03Recruiting
The Comparison of Outcomes of Antibiotic Drugs and Appendectomy (CODA) Trial [NCT02800785]1,552 participants (Actual)Interventional2016-05-31Completed
Oral Antibiotics to Prevent Infection and Wound Dehiscence After Obstetric Perineal Tear - a Double-blinded Placebo Controlled Randomized Trail [NCT05830162]Phase 4442 participants (Anticipated)Interventional2023-03-21Recruiting
A Randomized, Double-blind, Multicenter Trial to Evaluate the Safety and Efficacy of Sequential (Intravenous, Oral) Moxifloxacin Versus Comparator in Pediatric Subjects With Complicated Intra-abdominal Infection [NCT01069900]Phase 3458 participants (Actual)Interventional2010-07-21Completed
Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers [NCT01137903]88 participants (Anticipated)Interventional2010-04-30Recruiting
Trial of Faropenem and Cefadroxil (in Combination With Amoxicillin/Clavulanic Acid and Standard TB Drugs) in Patients With Pulmonary Tuberculosis: Measurement of Early Bactericidal Activity and Effects on Novel Biomarkers [NCT02381470]Phase 258 participants (Actual)Interventional2019-02-11Completed
A Phase 2 Trial to Evaluate the Early Bactericidal Activity and Safety of Meropenem With Amoxicillin/Clavulanate Plus Either Pyrazinamde or Bedaquiline in Adults With Newly Diagnosed Rifampicin-susceptible Pulmonary Tuberculosis [NCT04629378]Phase 222 participants (Actual)Interventional2020-08-17Completed
A Phase IV Double-Blind, Placebo-Controlled, Randomized Trial to Evaluate Short Course vs.Standard Course Outpatient Therapy of Community Acquired Pneumonia in Children (SCOUT-CAP) [NCT02891915]Phase 4385 participants (Actual)Interventional2016-12-02Completed
Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics [NCT02099240]Early Phase 111 participants (Actual)Interventional2014-03-06Terminated(stopped due to Not enough patient enrollment and lack of staffing)
A New Antibiotic Prophylaxis Regimen to Prevent Bacteremia Following Dental Procedures [NCT02115776]266 participants (Actual)Interventional2014-01-31Completed
COMPARISON OF CLINICAL EFFICACY OF COMBINATION Amoxycillin Plus Clavulanic Acid and Oxacillin Plus Ceftriaxone for HOSPITAL TREATMENT OF COMMUNITY Acquired PNEUMONIA IN CHILDREN : A Randomized Clinical Study [NCT01166932]Phase 4104 participants (Actual)Interventional2005-04-30Completed
The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines [NCT01089218]Phase 4241 participants (Actual)Interventional2008-04-30Completed
Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections [NCT04350502]11 participants (Actual)Interventional2020-04-04Completed
Prospective Randomized Clinical Study: Role of Platelet Rich Fibrin (PRF) in the Tooth Extraction Site in the Prevention of Jaw Osteonecrosis on Patients Under Bisphosphonates Therapy [NCT02198001]100 participants (Anticipated)Interventional2014-01-31Recruiting
Pneumonia in Children: Aetiology, Ideal Antibiotic Duration, Quality of Life [NCT02258763]Phase 419 participants (Actual)Interventional2014-11-30Completed
An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects Under Fasting Conditions [NCT00840099]Phase 148 participants (Actual)Interventional2002-08-31Completed
Randomized, 2-Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets and AUGMENTIN® 400 mg-57 mg Chewable Tablets Administered as 1 x 400 mg-57 mg Chewable Tablet in Healthy Subjects Under Fed Conditions [NCT00836901]Phase 152 participants (Actual)Interventional2003-09-30Completed
Evaluation of the Efficacy of an Antibiotic Combined With Standard Treatment in Severe Alcoholic Hepatitis [NCT02281929]Phase 3297 participants (Actual)Interventional2015-06-13Completed
Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis [NCT03625739]800 participants (Anticipated)Observational [Patient Registry]2018-07-01Recruiting
Study Of The Antibiotic Role In Post Tonsillectomy Complications [NCT03491085]Phase 1/Phase 2200 participants (Anticipated)Interventional2018-05-15Not yet recruiting
Oral Versus Intravenous Antibiotics for the Management of the Osteomyelitis of the Jaws: An Open-Label Non-Inferiority Single-Arm Clinical Trial [NCT05867654]100 participants (Anticipated)Observational2023-11-01Not yet recruiting
An Oral Amoxicillin-Clavulanate Regimen to Prevent Bacteremia Following [NCT02783404]Phase 440 participants (Actual)Interventional2017-02-27Terminated(stopped due to Significant results (no control neither amoxicillin new arms needed))
Antibiotic PRophylAxis Based on infeCTIve Risk in Cardiac Implantable Electronic Device - PRACTICE Study [NCT04736979]1,044 participants (Actual)Observational2017-01-01Completed
Is Combination Antibiotic Therapy Superior to Monotherapy in the Treatment of Acute Exacerbations of Chronic Obstructive Pulmonary Disease [NCT04879030]Phase 2/Phase 3170 participants (Actual)Interventional2020-01-01Completed
Рrospective Multicenter Randomized 3 Phase Study Evaluating the Role of Prolonged Antibiotic Prophylaxis as a Measure to Reduce the Incidence of Postoperative Complications After Radical Cystectomy With ERAS Protocol [NCT05392634]Phase 398 participants (Anticipated)Interventional2022-02-02Recruiting
An Open-Label, Single-Dose, Two-Way Crossover Bioequivalence Study of Two Oral Suspension Formulations of Amoxicillin/Clavulanate Potassium, 600/42.9 mg/5 mL in Healthy Subjects, Under Fed Conditions [NCT00840840]Phase 148 participants (Actual)Interventional2002-08-31Completed
Shortened Antibiotic Therapy for Febrile Urinary Tract Infection (UTI) in Childhood: a Multicenter Randomized Controlled Trial [NCT04400110]Phase 4154 participants (Actual)Interventional2020-06-08Completed
A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Sanfetrinem Cilexetil Administered Orally to Adults With Newly Diagnosed, Smear-Positive, Rifampicin-Susceptible Pulmonary Tuberculosis [NCT05388448]Phase 2105 participants (Anticipated)Interventional2022-04-21Recruiting
DIABOLO Trial: A Multicenter Randomized Clinical Trial Investigating the Cost-effectiveness of Treatment Strategies With or Without Antibiotics for Uncomplicated Acute Diverticulitis. [NCT01111253]Phase 4533 participants (Anticipated)Interventional2010-05-31Active, not recruiting
Antibiotic-associated Gastrointestinal Side Effects and the Role of the Gut Microbiome [NCT04156555]Phase 430 participants (Actual)Interventional2019-08-01Completed
Effects of Phenoximethylpenicillin, Amoxicillin and Amoxicillin-clavulanic Acid on the Gut Microbiota of Healthy Volunteers: a Randomized Clinical Trail [NCT04084106]Phase 4104 participants (Actual)Interventional2019-09-10Completed
Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial [NCT05977868]Phase 4135 participants (Anticipated)Interventional2023-08-04Enrolling by invitation
Randomized, 2-Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 400 mg-57 mg Chewable Tablets and AUGMENTIN® 400 mg-57 mg Chewable Tablets Administered as 1 x 400 mg-57 mg Chewable Tablet in Healthy Subjects Under Fasting Conditions [NCT00835705]Phase 152 participants (Actual)Interventional2003-09-30Completed
Prevention of Early Ventilator-associated Pneumonia With Antibiotic Therapy in Patients Treated With Mild Therapeutic Hypothermia After Cardiac Arrest. [NCT02186951]Phase 3197 participants (Actual)Interventional2014-08-18Completed
An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics of LP-001 Oral Suspension in Children With a Bacterial Infection [NCT05584683]Phase 124 participants (Anticipated)Interventional2022-12-12Not yet recruiting
Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients [NCT03120663]120 participants (Anticipated)Observational2016-11-30Recruiting
Home Intravenous Versus Oral Antibiotics Following Appendectomy for Perforated Appendicitis in Children, a Randomized Controlled Trial [NCT02724410]82 participants (Actual)Interventional2011-01-31Completed
Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure [NCT04980170]Early Phase 1100 participants (Anticipated)Interventional2021-11-01Not yet recruiting
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery [NCT03369717]Phase 4400 participants (Anticipated)Interventional2018-08-01Suspended(stopped due to Expired IRB approval since 05/07/2020)
Antibiotic Dosing in Pediatric Intensive Care [NCT02456974]640 participants (Anticipated)Observational [Patient Registry]2012-05-31Recruiting
Phase 2/3 Evaluation of Three Lactobacilli Strains Isolated From Human Milk for the Treatment of Infectious Mastitis During the Lactation Period [NCT00716183]Phase 2/Phase 3300 participants (Actual)Interventional2008-07-31Completed
Pharmacokinetic Study of the Amoxicillin / Clavulanic Acid Association to Optimize Dosage Among Obese Adults (PHACO) [NCT02571959]Phase 1/Phase 236 participants (Actual)Interventional2015-07-24Completed
Early Bactericidal Activity of Cephalexin and Amoxicillin-clavulanate for Susceptible Tuberculosis - BLAST 1 Trial [NCT05664568]Phase 230 participants (Anticipated)Interventional2023-03-15Recruiting
Non Operative Treatment for Acute Appendicitis: Study on Efficacy and Safety of Antibiotic Treatment (Amoxicillin and Clavulanic Acid) in Patients With Right Sided Lower Abdominal Pain [NCT01096927]Phase 4160 participants (Actual)Interventional2010-01-31Completed
Efficacy of Antimicrobials in Young Children With Acute Otitis Media (AOM) [NCT00377260]Phase 4291 participants (Actual)Interventional2006-11-30Completed
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia [NCT02735707]Phase 310,000 participants (Anticipated)Interventional2016-04-11Recruiting
Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact [NCT00801099]276 participants (Actual)Interventional2004-12-31Completed
Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery [NCT02764710]Phase 3250 participants (Anticipated)Interventional2016-05-31Not yet recruiting
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid [NCT00603317]Phase 413 participants (Actual)Interventional2008-03-31Completed
A Phase IIIB/IV Comparative Study of the Safety and Efficacy of Clarithromycin Extended-Release Tablets vs. Amoxicillin-Clavulanate for the Treatment of Subjects With Acute Bacterial Sinusitis [NCT00644553]Phase 3437 participants (Actual)Interventional2003-05-31Completed
Initial Non-operative Treatment Strategy Versus Appendectomy Treatment Strategy for Simple Appendicitis in Children Aged 7-17 Years Old - Antibiotics Versus Primary Appendectomy in Children With Simple Appendicitis: APAC Study [NCT02848820]Phase 4302 participants (Actual)Interventional2016-12-31Active, not recruiting
A Multicenter, Randomized, Double-Blind, Double-Dummy Comparative Trial of Azithromycin SR Versus Amoxicillin/Clavulanate Potassium (Augmentin ES-600 Trademark) for the Treatment of Acute Otitis Media in Children Undergoing Diagnostic Tympanocentesis [NCT00643292]Phase 3902 participants (Actual)Interventional2003-01-31Completed
Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR) [NCT05508152]Phase 3260 participants (Actual)Interventional2021-02-01Completed
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis [NCT06076304]Phase 4144 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media [NCT02567825]250 participants (Actual)Interventional2015-11-30Completed
Prospective, Multicenter, Randomized, Double Blind, Parallel Arm Study to Evaluate the Efficacy and Safety of Moxifloxacin 400 mg OD for 7 Days Versus a Standard Antibiotic Therapy for 10 Days in the Treatment of Acute Bacterial Rhino Sinusitis [NCT00493038]Phase 4293 participants (Actual)Interventional2006-02-28Terminated(stopped due to The study was prematurely terminated due to slow enrollment beyond the planned study timelines.)
Antibiotic Therapy is Not Necessary to Implant Totally Implantable Venous Access Devices: Randomized Prospective Study [NCT00665873]Phase 4100 participants (Actual)Interventional2004-01-31Completed
MAESTRAL - A Prospective, Multinational, Multicenter, Randomized, Double Blind, Double Dummy, Controlled Study Comparing the Efficacy and Safety of Moxifloxacin to That of Amoxicillin Clavulanic Acid for the Treatment of Subjects With Acute Exacerbations [NCT00656747]Phase 41,372 participants (Actual)Interventional2008-03-31Completed
A Phase 2 Randomized, Double-blind, Double-dummy Efficacy, Safety And Tolerability Study Of Iv Sulopenem With Switch To Oral Pf-03709270 Compared To Ceftriaxone With Step Down To Amoxicillin/Clavulanate Potassium (Augmentin) In Subjects With Community Acq [NCT00797108]Phase 235 participants (Actual)Interventional2009-01-31Completed
Supportive Care and Antibiotics for Severe Pneumonia Among Hospitalized Children [NCT04041791]Phase 34,392 participants (Anticipated)Interventional2019-08-19Recruiting
Randomized, Open - Label, 2 - Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 600mg - 42.9 mg/ 5 mL Oral Suspension and Augmentin ES - 600 (Reference) Following a 600 mg - 42.9 mg Dose in Healthy Subjects Under Fasting Conditions [NCT00778414]48 participants (Actual)Interventional2006-06-30Completed
[NCT04082598]Phase 4165 participants (Actual)Interventional2016-10-01Completed
A National, Prospective, Randomized, Open Label Study to Assess the Efficacy and Safety of IV/PO Moxifloxacin vs IV Ceftriaxone + IV Azithromycin Followed by PO Amoxicilline/Clavulanate and PO Clarithromycin in Subjects With Community-acquired Pneumonia [NCT00717561]Phase 360 participants (Actual)Interventional2008-02-29Completed
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales (PACUTI) [NCT05224401]Phase 3330 participants (Anticipated)Interventional2023-05-29Recruiting
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children [NCT01166945]98 participants (Actual)Interventional2010-11-30Completed
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Complicated Urinary Tract Infections [NCT01110408]Phase 341 participants (Actual)Interventional2010-12-31Terminated(stopped due to Trial terminated early per business decision)
A Prospective, Randomized, Double Dummy, Double Blind, Multinational, Multicenter Trial Comparing the Safety and Efficacy of Sequential (Intravenous/Oral) Moxifloxacin 400 mg OD to Intravenous Piperacillin/Tazobactam 4.0/0.5 g Every 8 Hours Followed by Or [NCT00402727]Phase 3813 participants (Actual)Interventional2006-09-30Completed
A Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of the Efficacy, Tolerability, and Safety of Oral Sulopenem Etzadroxil/Probenecid Versus Oral Amoxicillin/Clavulanate for Treatment of Uncomplicated Urinary Tract Infections (uUTI) in Ad [NCT05584657]Phase 32,229 participants (Actual)Interventional2022-10-18Active, not recruiting
Situations That do Not Require Antibiotics for Acute Exacerbations of Mild-to-moderate Chronic Obstructive Pulmonary Disease [NCT00495586]Phase 4318 participants (Actual)Interventional2007-10-31Completed
Randomized, Multicenter, Phase III, Controlled Clinical Trial, to Demonstrate the no Inferiority of Reduced Antibiotic Treatment vs a Broad Spectrum Betalactam Antipseudomonal Treatment in Patients With Bacteremia by Enterobacteriaceae [NCT02795949]Phase 3344 participants (Actual)Interventional2016-10-31Completed
Effect of Lactobacillus Reuteri DSM 17938 to Prevent Antibiotic-associated Diarrhea in Children: Prospective, Multi-center, Randomize, Parallel Group Placebo Controlled Clinical Trial [NCT02765217]Phase 41,325 participants (Actual)Interventional2017-06-01Completed
Randomized, Open-Label, 2 - Way Crossover, Bioequivalence Study of Amoxicillin-Clavulanic Acid 600 mg- 42.9 mg/ 5 mL Oral Suspension and Augmentin ES-600 (Reference) Following a 600 mg- 42.9 mg Dose in Healthy Subjects Under Fed Conditions. [NCT00778544]48 participants (Actual)Interventional2006-06-30Completed
Multiple-dose Pharmacokinetics of Ampicillin / Sulbactam and Amoxicillin / Clavulanic Acid During Haemodialysis in Longterm Haemodialysis Patients [NCT02007603]Phase 316 participants (Actual)Interventional2013-08-31Completed
A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL) [NCT00147914]Phase 4100 participants (Actual)Interventional2005-02-28Completed
A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess [NCT03795194]Phase 412 participants (Actual)Interventional2019-05-01Terminated(stopped due to Due to low enrollment.)
Exploratory Pilot Studies to Demonstrate Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics [NCT03755765]Early Phase 166 participants (Actual)Interventional2019-07-23Completed
A Phase IA Open Label Pharmaco- Magnetic Resonance Spectrography (MRS) Study of Clavulanic Acid Daily Repeated Administration in Remitted Cocaine Use Disorder Subjects [NCT03986762]Phase 19 participants (Actual)Interventional2019-03-12Completed
Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial - (PARFAIT) A Vanguard Randomized Controlled Trial [NCT04549311]Phase 315 participants (Actual)Interventional2021-11-18Active, not recruiting
A Phase 2a Study of the Early Bactericidal Activity of Rifampin (RIF) in Combination With Meropenem Plus Amoxicillin/Clavulanate Among Adults With Rifampin-resistant or Rifampin-susceptible Pulmonary Tuberculosis [NCT03174184]Phase 2112 participants (Actual)Interventional2017-08-23Completed
Beta-Lactam Containing Regimen for the Shortening of Buruli Ulcer Disease Therapy: Comparison of 8 Weeks Standard Therapy (Rifampicin Plus Clarithromycin) vs. 4 Weeks Standard Plus Amoxicillin/Clavulanate Therapy [RC8 vs. RCA4] [NCT05169554]Phase 2140 participants (Anticipated)Interventional2021-12-01Recruiting
CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial [NCT05846399]Phase 472 participants (Anticipated)Interventional2023-09-07Recruiting
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Meropenem in Hospitalized Children With Complicated Intra-Abdominal Infections [NCT01110382]Phase 341 participants (Actual)Interventional2010-12-31Terminated(stopped due to Trial terminated early per business decision)
Does Adjuvant Antibiotic Treatment After Drainage of Anorectal Abscess Prevent the Development of Anal Fistulae? A Prospective Randomized, Placebo Controlled, Double Blind, Multi-Center Clinical Study [NCT01012843]151 participants (Actual)Interventional2005-09-30Completed
Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe [NCT01015417]Phase 3414 participants (Actual)Interventional2010-05-31Completed
Open-label Comparative Safety and Efficacy Study of Levofloxacin and Amoxicillin Clavulanic Acid in Patients With Acute ,Bacterial Rhinosinusitis [NCT02712502]100 participants (Actual)Observational2014-09-30Completed
Multicentre Controlled, Randomized Clinical Trial to Compare the Efficacy and Safety of Ambulatory Treatment of Mild Acute Diverticulitis Without Antibiotics With the Standard Treatment With Antibiotics [NCT02785549]Phase 4480 participants (Actual)Interventional2016-11-30Completed
Special Drug Use Investigation for CLAVAMOX® (Amoxicillin/Clavulanate) Pediatrics Dry Syrup (Every Indication Excluded Otitis Media) [NCT01406275]363 participants (Actual)Observational2008-01-31Completed
A Multicenter Randomized Controlled Trial of Antibiotic Treatment in Children With Urinary Tract Infections: Oral Amoxicillin/Clavulanic Acid vs Initial iv Ceftriaxone. [NCT00161330]Phase 3440 participants Interventional2000-06-30Terminated
Fast-track Absolute Neutrophil Count in Suspected Neutropenic Fever (The FRANCiS-NF Trial): A Single-centre, Pragmatic, Open-label, Randomised, Controlled Trial [NCT05393505]Phase 4344 participants (Anticipated)Interventional2022-10-24Recruiting
Exploratory Pilot Studies to Demonstrate Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics [NCT04414722]Early Phase 1138 participants (Actual)Interventional2021-01-01Completed
A Prospective, Multicenter, Randomized, Open-Label, Comparative Study to Evaluate the Safety, Tolerability, and Efficacy of Ertapenem Sodium ( MK0826) Versus Ticarcillin/Clavulanate in the Treatment of Hospital-Acquired Pneumonia, Complicated Intra-Abdomi [NCT00092170]Phase 2100 participants Interventional2002-03-31Completed
Prophylactic Versus Clinically-driven Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest [NCT02899507]Phase 460 participants (Actual)Interventional2013-09-30Completed
The Efficiency of Postoperative Antibiotics in Orthognathic Surgery: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT02740647]25 participants (Anticipated)Interventional2016-04-30Not yet recruiting
Phase 1, Double-Blind, Placebo-Controlled Assessment of Potential Interactions Between Intravenous Cocaine and Clavulanic Acid [NCT02563769]Phase 110 participants (Actual)Interventional2016-10-24Completed
Multicentre, Randomised, Double-blinded, Placebo-controlled Trial of Efficacy of Amoxicilline/Clavulanic Acid in Patients Affected by Tic Disorder Colonized by Group A Streptococcus [NCT01860300]46 participants (Anticipated)Interventional2013-03-31Recruiting
A Prospective Randomised Phase III Trial of Early Hospital Discharge Versus Standard Inpatient Management of Cancer Patients With Low-Risk Febrile Neutropenia Receiving Oral Antibiotics. Oral Antibiotics for Neutropenic Sepsis Giving Early Hospital Discha [NCT00445497]Phase 3400 participants (Anticipated)Interventional2007-07-31Recruiting
The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children [NCT00456339]Phase 44 participants (Actual)Interventional2006-07-31Terminated(stopped due to Problems recruiting; patient relapse following treatment)
Efficacy and Cost Efficacy of Prophylactic Treatment With Antibiotics During Concomitant Chemoradiotherapy in Patients With Locally Advanced Head and Neck Cancer to Prevent Aspiration Pneumonia. A Randomized Phase II-III Study [NCT01598402]Phase 2/Phase 3106 participants (Anticipated)Interventional2011-12-31Recruiting
Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study [NCT00545961]Phase 4120 participants (Anticipated)Interventional2007-11-30Not yet recruiting
A Phase 4 Double Blinded Study With Two Different Interventions, Each With Two Arms, to Evaluate the Clinical Efficacy of Antibiotics and the Role of Microbiology, Immunology and Genetics in Children Aged 9-36 Months With Chronic Wet Cough. [NCT06020716]Phase 4350 participants (Anticipated)Interventional2023-08-16Recruiting
Effect of Preoperative, Single-dose Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Double-Blind Randomized Controlled Trial. [NCT03033147]72 participants (Actual)Interventional2019-10-18Completed
Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children [NCT00299455]Phase 4320 participants (Anticipated)Interventional2006-03-31Active, not recruiting
An Open, Non-comparative Study to Evaluate the Efficacy and Safety of AUGMENTIN 1gm (875mg Amoxicillin/125mg Clavulanic Acid) po q 12 Hours in the Treatment of Uncomplicated Skin and Soft Tissue Infections in Pakistan [NCT00343135]Phase 4195 participants (Actual)Interventional2004-12-31Completed
A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis [NCT00135603]243 participants (Actual)Interventional2004-02-29Completed
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry [NCT01244581]Phase 384 participants (Actual)Interventional1999-09-30Completed
Evaluation of National Guidelines for Acute Sinusitis [NCT00132275]240 participants (Anticipated)Interventional2003-11-30Completed
eXtended Antibiotic Prophylaxis for Intermediate- and High-risk Glands After Pancreatoduodenectomy to Reduce Clinically Relevant PostOperative Pancreatic Fistula: A Phase 2 Randomized Control Trial (X-POPF) [NCT05753735]Phase 296 participants (Anticipated)Interventional2023-12-20Recruiting
Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital [NCT04321733]66 participants (Anticipated)Observational2020-04-30Not yet recruiting
Effectiveness of Maxillary Sinus Saline Irrigation in Conjunction With Systemic Antibiotic Therapy Versus Systemic Antibiotic Therapy Alone in the Management of Chronic Rhinosinusitis, a Prospective Randomized Controlled Trial [NCT00335309]50 participants (Actual)Interventional2005-10-31Completed
Phase 3 Study of Antibiotic Prophylaxis Use Prior Emergent Surgery, Because of Acute Appendicitis [NCT01524081]Phase 3187 participants (Actual)Interventional2008-07-31Completed
A Multicenter, Randomized, Observer-Blinded, Active-Controlled Study Evaluating the Safety, Tolerability, Pharmacokinetics, and Efficacy of Ceftaroline Versus Ceftriaxone in Pediatric Subjects With Community-acquired Bacterial Pneumonia Requiring Hospital [NCT01530763]Phase 2/Phase 3161 participants (Actual)Interventional2012-09-30Completed
[NCT00042718]Phase 3659 participants (Actual)Interventional2001-11-30Completed
A Multicenter, Randomized, Comparative Study to Evaluate the Efficacy and Safety of Levofloxacin in the Treatment of Children Who Have Recurrent and/or Persistent Acute Otitis Media [NCT00051753]Phase 31,643 participants (Actual)Interventional2002-11-30Completed
A Phase 2b, Multicenter, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Evaluate the Efficacy of Short-Course Antimicrobial Therapy for Young Children With Acute Otitis Media (AOM) and Impact on Antimicrobial Resistance [NCT01511107]Phase 2520 participants (Actual)Interventional2012-01-31Terminated(stopped due to The primary objective of the study was met.)
Standard vs. Biofilm Susceptibility Testing in CF [NCT00153634]75 participants (Actual)Interventional2004-03-31Completed
Oral Empirical Therapy of Fever in Low-Risk Neutropenic Cancer Patients: A Prospective, Double-Blind, Randomized, Multicenter Trial Comparing Monotherapy (Single Daily Dose Moxifloxacin) With Combination Therapy (Ciprofloxacin Plus Amoxicillin/Clavulanic [NCT00062231]351 participants (Actual)Interventional2002-04-30Terminated(stopped due to low accrual)
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media [NCT02630992]Phase 3112 participants (Actual)Interventional2015-12-31Completed
Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric Protracted Bacterial Bronchitis: a Randomized Controlled Study. [NCT04378231]100 participants (Anticipated)Interventional2020-05-31Not yet recruiting
The Efficacy of Preventive Antibiotic Treatment During the Puerperium Among Pregnant Women With Recurrent Urinary Tract Infections [NCT01507974]220 participants (Actual)Interventional2012-01-16Completed
Continuous-infusion Anti-pseudomonal β-lactams for the Treatment of Acute, Infective Pulmonary Exacerbations in Cystic Fibrosis [NCT01667094]Phase 450 participants (Actual)Interventional2012-09-30Active, not recruiting
The Use of Prophylactic Antibiotics in Endoscopy Sinus Surgery for Chronic Rhinosinusitis With or Without Polyp: A Randomized, Double-blind Clinical Trial [NCT03809312]Phase 4134 participants (Anticipated)Interventional2019-08-14Recruiting
A Third Phase, Multicentre, Randomized as a Double Blind Study, Triple Placebo, Comparative of the Efficacy and Safety of an Association Secnidazol-Ciprofloxacin Compared With Amoxicillin-Clavulanic Acid for the Treatment of Uncomplicated Episode of Diver [NCT01733966]Phase 3100 participants (Actual)Interventional2010-05-31Terminated(stopped due to difficulties to recruit patients who suffer from this pathology)
Bacteriology and Sputum and Systemic Inflammation in Steady-state, Acute Exacerbation and Recovery of Bronchiectasis [NCT01761214]80 participants (Anticipated)Interventional2012-09-30Recruiting
Bioequivalence Study of an Amoxicillin-Clavulanic Acid Suspension Preparation. Cross-over, Randomized, Single Dose, Two Treatments, Two Periods and Two Sequences Trial in Fasting Conditions [NCT01772238]Phase 135 participants (Actual)Interventional2011-03-22Completed
Comparison of a Serum Procalcitonin (PRO-CT) Guided Treatment Plan With the Standard Guideline Recommended Antibiotic Treatment Plan for Patients Hospitalized With a Diagnosis of Exacerbation of COPD [NCT01125098]183 participants (Actual)Observational2006-10-31Completed
Per Oral Versus Intravenous Postoperative Antibiotics After Surgery for Complicated Appendicitis: A Cluster Randomized Cluster Crossover Non-Inferiority Study. [NCT04803422]2,631 participants (Anticipated)Interventional2021-05-01Recruiting
Open Label, Randomized Pilot Study to Examine The Effects of the Probiotic Saccharomyces Boulardii, the Antibiotic Amoxicillin/Clavulanate and the Combination on the Gut Microbiota of Healthy Volunteers [NCT01473368]53 participants (Actual)Interventional2012-04-30Completed
A Multicenter, Open-Label Study To Assess The Efficacy And Safety Of Potassium Clavulanate/Amoxicillin (CVA/AMPC 1:14 Combination) In The Treatment Of Children With Acute Bacterial Rhinosinusitis [NCT01934231]Phase 327 participants (Actual)Interventional2013-08-30Completed
A Study to Determine PK Profiles of AUGMENTIN XR in Adolescents Weight at Least 40 kg Receiving Augmentin XR BID for 10 Days [NCT00354965]Phase 152 participants (Actual)Interventional2006-01-19Completed
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate [NCT02340000]Phase 4315 participants (Actual)Interventional2014-11-18Completed
Risk of Acute Liver Injury in Users of Antimicrobials in the HealthCore Integrated Research Database Population [NCT01434173]1,299,056 participants (Actual)Observational2001-07-31Completed
Pharmacokinetics of Antistaphylococcal Antibiotics in Infants [NCT01728363]Phase 163 participants (Actual)Interventional2013-01-31Completed
Prospective, Phase 3, Randomized, Multi-center, Double-blind Study of Efiicacy, Tolerability & Safety of Sulopenem & Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro-metronidazole for Treatment of cIAI in Adults [NCT03358576]Phase 3674 participants (Actual)Interventional2018-09-18Completed
A Prospective, Randomized, Double-Blind, Multicenter Study to Establish the Safety and Tolerability of Doripenem Compared With Cefepime in Hospitalized Children With Bacterial Pneumonia [NCT01110421]Phase 37 participants (Actual)Interventional2010-12-31Terminated(stopped due to Trial terminated early per business decision)
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics [NCT05761080]Phase 4158 participants (Anticipated)Interventional2021-04-22Recruiting
A Phase 2/3, Randomized, Open-Label, Multi-center Study to Determine the Safety and Efficacy of Solithromycin in Adolescents and Children With Suspected or Confirmed Community-Acquired Bacterial Pneumonia [NCT02605122]Phase 2/Phase 397 participants (Actual)Interventional2016-04-30Terminated(stopped due to Development not proceeding)
Early Stoppage Versus Continuation of Antimicrobial Therapy in Low Risk Pediatric Cancer Patients With Febrile Neutropenia, Before Recovery of Counts: a Randomized Controlled Study -DALFEN Study [NCT03003273]Phase 3142 participants (Anticipated)Interventional2017-01-31Terminated(stopped due to poor accrual)
A Multi-centre Double-blind Randomised Controlled Trial to Determine if a Longer Duration of Amoxicillin-clavulanic Acid (Compared to Shorter Duration) Improves Clinical Outcomes of Children Hospitalised With Community-acquired Pneumonia [NCT02783859]Phase 4314 participants (Anticipated)Interventional2016-06-30Active, not recruiting
A Randomised Controlled Trial of Continuing Immunoglobulin Therapy, or Stopping With or Without Prophylactic Antibiotics, on Infection Rate in Patients With Acquired Hypogammaglobulinemia Secondary to Haematological Malignancies. [NCT05678621]Phase 2/Phase 3300 participants (Anticipated)Interventional2023-01-31Not yet recruiting
Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia [NCT01559753]Phase 4225 participants (Actual)Interventional1998-01-31Completed
Duration of Postoperative Antibiotic Prophylaxis in Facial Fractures (Mandibular Fractures, Zygomaticoorbital Fractures, Isolated Orbital Blow-out Fractures and LeFort I/II/III Fractures): 1 Day vs. 5 Days: a Prospective, Randomized, Double Blind and Plac [NCT01583062]Phase 4217 participants (Actual)Interventional2006-01-31Terminated(stopped due to Limited number of patients)
Effect of Antimicrobial Treatment of Acute Otitis Media on the Intestinal Microbiome in Children: A Randomized Controlled Trial [NCT02935374]Phase 473 participants (Actual)Interventional2016-11-30Completed
A Study to Assess the Safety, Tolerability and Efficacy of OP0201 as an Adjunct Treatment for Acute Otitis Media in Infants and Children Aged 6 to 24 Months [NCT03818815]Phase 2103 participants (Actual)Interventional2019-02-21Completed
Acupuncture and Herbal Treatment of Chronic HIV Sinusitis [NCT00002149]40 participants InterventionalCompleted
Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration [NCT05079620]Phase 4100 participants (Anticipated)Interventional2021-11-30Recruiting
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit? [NCT02554383]Phase 3515 participants (Actual)Interventional2016-02-29Completed
Prospective, Phase 3, Randomized, Multi-center, Double-blind, Double-dummy Study of Efficacy, Tolerability & Safety of Sulopenem Followed by Sulopenem-etzadroxil/Probenecid vs Ertapenem Followed by Cipro for Treatment of cUTI in Adults [NCT03357614]Phase 31,395 participants (Actual)Interventional2018-09-18Completed
2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy [NCT04268407]60 participants (Actual)Interventional2020-02-26Completed
Delineation of Therapeutic Potential and the Causal Relationship Between Vitamin D and Helicobacter Pylori (HP) Infection and Gastritis [NCT03142620]Phase 396 participants (Anticipated)Interventional2015-03-31Recruiting
Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study [NCT03295955]50 participants (Anticipated)Interventional2017-09-04Recruiting
Antibiotic Profile of Pathogenic Bacteria Isolated From Postsurgical Site Infections in Public Hospitals in Northern Jordan [NCT05106803]24 participants (Actual)Observational2019-08-01Completed
A Phase 2 Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of Meropenem, Administered Intravenously, Plus Amoxycillin/CA and Faropenem, Administered Orally, Plus Amoxycillin/CA in Adult Patients With Newly Diagnosed, Smear-positi [NCT02349841]Phase 246 participants (Actual)Interventional2014-09-30Completed
A Phase 1B Double Blind, Placebo (PBO) Controlled, Pharmaco- Magnetic Resonance Spectroscopy (MRS) Inpatient Study of Clavulanic Acid (CLAV) 500, 750, 1000 mg Daily Repeated Administration in Early Remitted Cocaine Use Disorder Subjects [NCT04411914]Phase 113 participants (Actual)Interventional2020-09-01Completed
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori. [NCT01575899]Phase 4208 participants (Actual)Interventional2007-12-31Terminated(stopped due to Early termination due to efficacy)
Postoperative Healthcare Utilization in Adenotonsillectomy Patients With Postoperative Antibiotic Administration Compared to Patients Without Antibiotic Administration [NCT01561703]58 participants (Actual)Interventional2012-03-31Completed
Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract [NCT02021006]Phase 3292 participants (Actual)Interventional2013-12-31Active, not recruiting
Prospective Randomized Clinical Trial Assessing the Efficacy of a Short Course of Intravenous Amoxicillin Plus Clavulanic Acid Followed by Oral Antibiotic in Patients With Uncomplicated Acute Diverticulitis [NCT00917592]Phase 450 participants (Actual)Interventional2005-12-31Completed
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial [NCT01919411]Phase 4134 participants (Actual)Interventional2013-02-28Completed
Phase 1 Study to Evaluate the Effect of Oral Administration of Tebipenem Pivoxil Hydrobromide on Normal Human Intestinal Microbiota in Healthy Volunteers [NCT04376554]Phase 130 participants (Actual)Interventional2020-02-10Completed
Azithromycin With Amoxicillin/Clavulanate Versus Amoxicillin/Clavulanate Alone in COVID-19 Patients With Pneumonia and Hospitalized in a Non-intensive Care Unit Ward (AziA): a Superiority Open-label Randomized Controlled Trial [NCT04363060]Phase 3104 participants (Anticipated)Interventional2020-04-30Not yet recruiting
PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery [NCT03574090]Phase 4268 participants (Actual)Interventional2020-10-20Completed
Intravenous Versus Intravenous/Oral Antibiotics for Perforated Appendicitis [NCT00462020]102 participants (Actual)Interventional2007-03-31Completed
Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial [NCT03007342]78 participants (Anticipated)Interventional2017-01-31Not yet recruiting
Amoxicillin-clavulanate Alone or in Combination With Ciprofloxacin in Low-Risk Febrile Neutropenic Adult Patients: A Prospective, Double-blind, Randomized, Non-Inferiority Multicenter, Phase III Clinical Trial. [NCT04698057]Phase 30 participants (Actual)Interventional2022-03-01Withdrawn(stopped due to No enrolment due to Covid-19)
Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers [NCT02393586]Phase 143 participants (Actual)Interventional2015-02-28Completed
An fMRI Study of the Effects of Clavulanic Acid on Drug Addiction [NCT03713424]Phase 230 participants (Anticipated)Interventional2019-03-26Recruiting
Intravenous to Oral Antibiotic Switch Therapy for Probable Neonatal Bacterial Infections: Clinical Efficacy, Safety and Cost-effectiveness [NCT03247920]Phase 4510 participants (Actual)Interventional2017-11-04Completed
The Effect of Rectal Swab Culture-guided Antimicrobial Prophylaxis in Men Undergoing Prostate Biopsy on Infectious Complications and Cost of Care: A Randomized Controlled Trial in the Netherlands. [NCT03228108]Phase 41,538 participants (Actual)Interventional2018-04-03Completed
A Multicenter, Randomized, Open Label Comparative Study Of Azithromycin Extended Release (ZMAX) Versus Amoxicillin/Clavulanate Potassium In Subjects With Acute Bacterial Sinusitis (ABS) In A Physician Practice Environment [NCT00367120]Phase 4762 participants (Actual)Interventional2006-06-30Completed
Efficacy, Safety and Tolerability of Amoxicillin + Clavulanic Acid (875mg/125mg) Two Times a Day Compared to Clindamycin (150mg) Four Times a Day for 5-7 Days in Treatment of Acute Odontogenic Infection With or Without Abscess [NCT02141217]Phase 4472 participants (Actual)Interventional2013-03-21Completed
Randomized Study Comparing Clinical and Microbiological Efficacy of Timentin Delivered Via Percutaneous Isolated Limb Perfusion (PILP) or Intravenous Infusion in Diabetic Subjects With Moderate to Severe Lower Limb Infection [NCT02158442]Phase 215 participants (Actual)Interventional2013-10-31Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00377260 (24) [back to overview]The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment
NCT00377260 (24) [back to overview]The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment
NCT00377260 (24) [back to overview]The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment
NCT00377260 (24) [back to overview]The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment
NCT00377260 (24) [back to overview]The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment
NCT00377260 (24) [back to overview]The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment
NCT00377260 (24) [back to overview]The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit
NCT00377260 (24) [back to overview]The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment
NCT00377260 (24) [back to overview]The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Mean Number of Emergency Room Visits According to Treatment Assignment
NCT00377260 (24) [back to overview]The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment
NCT00377260 (24) [back to overview]The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment
NCT00377260 (24) [back to overview]The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment
NCT00377260 (24) [back to overview]The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment
NCT00377260 (24) [back to overview]The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment
NCT00377260 (24) [back to overview]The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment
NCT00402727 (12) [back to overview]Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population
NCT00402727 (12) [back to overview]Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms
NCT00402727 (12) [back to overview]Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population
NCT00402727 (12) [back to overview]Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms
NCT00402727 (12) [back to overview]Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population
NCT00402727 (12) [back to overview]Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population
NCT00402727 (12) [back to overview]Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population
NCT00402727 (12) [back to overview]Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population
NCT00402727 (12) [back to overview]Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population
NCT00402727 (12) [back to overview]Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population
NCT00402727 (12) [back to overview]Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms
NCT00402727 (12) [back to overview]Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population
NCT00462020 (5) [back to overview]Total Healthcare Visits
NCT00462020 (5) [back to overview]Length of Stay After Operation
NCT00462020 (5) [back to overview]Abscess After Appendectomy
NCT00462020 (5) [back to overview]Operative Time
NCT00462020 (5) [back to overview]Time to Regular Diet
NCT00493038 (5) [back to overview]Number of Participants With Response (Microbiologically Valid Patients)
NCT00493038 (5) [back to overview]Number of Participants With Response (Per-protocol Population)
NCT00493038 (5) [back to overview]Number of Participants With Response (Microbiologically Valid Patients)
NCT00493038 (5) [back to overview]Number of Participants With Response (Per-protocol Population)
NCT00493038 (5) [back to overview]Number of Participants With Response (Intent-to-treat Population)
NCT00495586 (2) [back to overview]Number of Patients Who Were Cured
NCT00495586 (2) [back to overview]Number of Days Till the Next Exacerbation
NCT00797108 (8) [back to overview]Number of Participants With Microbiological Response at Test of Cure (TOC) Visit
NCT00797108 (8) [back to overview]Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit
NCT00797108 (8) [back to overview]Number of Participants With Abnormal Physical Examination Findings
NCT00797108 (8) [back to overview]Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit
NCT00797108 (8) [back to overview]Number of Participants Who Died
NCT00797108 (8) [back to overview]Number of Participants With Abnormal Laboratory Test Findings
NCT00797108 (8) [back to overview]Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit
NCT00797108 (8) [back to overview]Number of Participants With Categorical Change From Baseline in Vital Signs
NCT00801099 (1) [back to overview]Number of Participants With Surgical Site Infections
NCT00835705 (6) [back to overview]AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
NCT00835705 (6) [back to overview]AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid
NCT00835705 (6) [back to overview]AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
NCT00835705 (6) [back to overview]AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid
NCT00835705 (6) [back to overview]Cmax (Maximum Observed Concentration) - Clavulanic Acid
NCT00835705 (6) [back to overview]Cmax (Maximum Observed Concentration) - Amoxicillin
NCT00836901 (6) [back to overview]AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid
NCT00836901 (6) [back to overview]AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin
NCT00836901 (6) [back to overview]AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid
NCT00836901 (6) [back to overview]AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin
NCT00836901 (6) [back to overview]Cmax (Maximum Observed Concentration) - Clavulanic Acid
NCT00836901 (6) [back to overview]Cmax (Maximum Observed Concentration) - Amoxicillin
NCT00840099 (6) [back to overview]Bioequivalence Based on Cmax for Amoxicillin
NCT00840099 (6) [back to overview]Bioequivalence Based on AUC0-inf for Amoxicillin
NCT00840099 (6) [back to overview]Bioequivalence Based on AUC0-inf for Clavulanic Acid
NCT00840099 (6) [back to overview]Bioequivalence Based on AUC0-t for Amoxicillin
NCT00840099 (6) [back to overview]Bioequivalence Based on AUC0-t for Clavulanic Acid
NCT00840099 (6) [back to overview]Bioequivalence Based on Cmax for Clavulanic Acid
NCT00840840 (6) [back to overview]Bioequivalence Based on Cmax for Clavulanic Acid
NCT00840840 (6) [back to overview]Bioequivalence Based on AUC0-inf for Amoxicillin
NCT00840840 (6) [back to overview]Bioequivalence Based on AUC0-inf for Clavulanic Acid
NCT00840840 (6) [back to overview]Bioequivalence Based on Cmax for Amoxicillin
NCT00840840 (6) [back to overview]Bioequivalence Based on AUC0-t for Clavulanic Acid
NCT00840840 (6) [back to overview]Bioequivalence Based on AUC0-t for Amoxicillin
NCT01069900 (20) [back to overview]Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
NCT01069900 (20) [back to overview]Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
NCT01069900 (20) [back to overview]Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
NCT01069900 (20) [back to overview]Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term
NCT01069900 (20) [back to overview]Number of Subjects With Clinical Cardiac Adverse Events
NCT01069900 (20) [back to overview]Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)
NCT01069900 (20) [back to overview]Bacteriological Response at a 'During Therapy' Visit
NCT01069900 (20) [back to overview]Bacteriological Response at Test-of-Cure (TOC) Visit
NCT01069900 (20) [back to overview]Bacteriological Response at the End of Treatment (EOT) Visit
NCT01069900 (20) [back to overview]Clinical Response at a 'During Therapy' Visit
NCT01069900 (20) [back to overview]Clinical Response at Test-of-Cure (TOC) Visit
NCT01069900 (20) [back to overview]Number of Subjects With Adverse Events
NCT01069900 (20) [back to overview]Number of Subjects With Musculoskeletal Adverse Events
NCT01069900 (20) [back to overview]Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3
NCT01069900 (20) [back to overview]Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3
NCT01069900 (20) [back to overview]PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
NCT01069900 (20) [back to overview]Clinical Response at the End-of-Treatment (EOT) Visit
NCT01069900 (20) [back to overview]QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3
NCT01069900 (20) [back to overview]QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
NCT01069900 (20) [back to overview]RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3
NCT01110382 (7) [back to overview]The Number of Participants With Favorable Per-participant Microbiological Response
NCT01110382 (7) [back to overview]Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
NCT01110382 (7) [back to overview]Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
NCT01110382 (7) [back to overview]The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit
NCT01110382 (7) [back to overview]The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
NCT01110382 (7) [back to overview]The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit
NCT01110382 (7) [back to overview]Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
NCT01110408 (7) [back to overview]The Number of Participants With Favorable Per-participant Microbiological Response
NCT01110408 (7) [back to overview]The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
NCT01110408 (7) [back to overview]The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit
NCT01110408 (7) [back to overview]Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
NCT01110408 (7) [back to overview]Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
NCT01110408 (7) [back to overview]Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
NCT01110408 (7) [back to overview]The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit
NCT01110421 (7) [back to overview]The Number of Participants With Favorable Per-participant Microbiological Response Rate
NCT01110421 (7) [back to overview]The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit
NCT01110421 (7) [back to overview]The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit
NCT01110421 (7) [back to overview]The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit
NCT01110421 (7) [back to overview]Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit
NCT01110421 (7) [back to overview]Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
NCT01110421 (7) [back to overview]Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit
NCT01125098 (1) [back to overview]To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy.
NCT01166945 (2) [back to overview]Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline
NCT01166945 (2) [back to overview]Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)
NCT01473368 (6) [back to overview]Gastrointestinal Symptom Rating Scale
NCT01473368 (6) [back to overview]Gastrointestinal Symptoms Response Scale
NCT01473368 (6) [back to overview]Gastrointestinal Symptoms Response Score
NCT01473368 (6) [back to overview]Operational Taxonomic Units
NCT01473368 (6) [back to overview]Prevalence of Escherichia in Stool
NCT01473368 (6) [back to overview]Gastrointestinal Symptom Rating Scale
NCT01511107 (22) [back to overview]The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen
NCT01511107 (22) [back to overview]The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment
NCT01511107 (22) [back to overview]The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen
NCT01511107 (22) [back to overview]The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen
NCT01511107 (22) [back to overview]The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up
NCT01511107 (22) [back to overview]The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product
NCT01511107 (22) [back to overview]The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate
NCT01511107 (22) [back to overview]The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate
NCT01511107 (22) [back to overview]The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product
NCT01511107 (22) [back to overview]The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit
NCT01511107 (22) [back to overview]The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen
NCT01511107 (22) [back to overview]The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM
NCT01511107 (22) [back to overview]The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen
NCT01511107 (22) [back to overview]The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment
NCT01511107 (22) [back to overview]The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season
NCT01511107 (22) [back to overview]The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14
NCT01511107 (22) [back to overview]The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season
NCT01511107 (22) [back to overview]The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate
NCT01511107 (22) [back to overview]The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate
NCT01511107 (22) [back to overview]The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered
NCT01511107 (22) [back to overview]The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season
NCT01511107 (22) [back to overview]The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen
NCT01561703 (1) [back to overview]Healthcare Utilization
NCT01575899 (3) [back to overview]Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
NCT01575899 (3) [back to overview]Eradication Rate of Participants Living in Rural Area.
NCT01575899 (3) [back to overview]Re-eradication Rate
NCT01919411 (6) [back to overview]Lund Kennedy Endoscopic Score
NCT01919411 (6) [back to overview]Number of Participants With Post Operative Infection
NCT01919411 (6) [back to overview]Number of Participants With Post Operative Infection
NCT01919411 (6) [back to overview]Sinonasal Outcome Test - 22
NCT01919411 (6) [back to overview]Lund Kennedy Endoscopic Score
NCT01919411 (6) [back to overview]Sinonasal Outcome Test - 22
NCT01934231 (6) [back to overview]"Number of Participants With a Clinical Outcome of Cure at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)"
NCT01934231 (6) [back to overview]"Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC: Day 15)"
NCT01934231 (6) [back to overview]"Number of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT: Day 8)"
NCT01934231 (6) [back to overview]Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)
NCT01934231 (6) [back to overview]Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8
NCT01934231 (6) [back to overview]Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15
NCT02141217 (5) [back to overview]Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5
NCT02141217 (5) [back to overview]Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5
NCT02141217 (5) [back to overview]Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)
NCT02141217 (5) [back to overview]Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7
NCT02141217 (5) [back to overview]Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7
NCT02158442 (1) [back to overview]Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.
NCT02340000 (6) [back to overview]Willingness to Take the Study Antibiotic in the Future
NCT02340000 (6) [back to overview]Nasal Colonization With Resistant Bacteria
NCT02340000 (6) [back to overview]SNOT-16 - Day 10
NCT02340000 (6) [back to overview]SNOT-16 - Day 3
NCT02340000 (6) [back to overview]Subjective Improvement - Day 10
NCT02340000 (6) [back to overview]"Subjective Improvement - Day 3 (Rating of a Lot Better or no Symptoms)"
NCT02554383 (8) [back to overview]The Distribution of Children Experiencing Treatment Failure (TF)
NCT02554383 (8) [back to overview]The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment
NCT02554383 (8) [back to overview]The Distribution of Children Compliant With Study Medication
NCT02554383 (8) [back to overview]The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment
NCT02554383 (8) [back to overview]The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit
NCT02554383 (8) [back to overview]The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up
NCT02554383 (8) [back to overview]The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported
NCT02554383 (8) [back to overview]The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up
NCT02563769 (8) [back to overview]Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing
NCT02563769 (8) [back to overview]Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing
NCT02563769 (8) [back to overview]Pharmacokinetic (PK) Parameter of Cocaine-concentration
NCT02563769 (8) [back to overview]Number of Participants With Severe Adverse Events (AEs)
NCT02563769 (8) [back to overview]Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing
NCT02563769 (8) [back to overview]Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses
NCT02563769 (8) [back to overview]Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses
NCT02563769 (8) [back to overview]Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid
NCT02567825 (12) [back to overview]The Distribution of Children With a Penicillin-Nonsusceptible Nasopharyngeal or Throat Isolate At Any Follow-up Visit According to the Colonization Status at Enrollment
NCT02567825 (12) [back to overview]The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment
NCT02567825 (12) [back to overview]The Mean Scores on the 6 Item Quality of Life Survey Questionnaire (OM-6)
NCT02567825 (12) [back to overview]The Mean Scores on the 6 Item Caregiver Impact Questionnaire (CIQ)
NCT02567825 (12) [back to overview]The Mean Days Per Year Children Experience AOM Symptoms With an Intact Tympanic Membrane (TM)
NCT02567825 (12) [back to overview]The Mean Days Per Year Children Experience Tube Otorrhea
NCT02567825 (12) [back to overview]The Mean Days Per Year Children Receive Systemic Antimicrobials for AOM
NCT02567825 (12) [back to overview]The Mean Score Representing Parental Satisfaction With Clinical Management
NCT02567825 (12) [back to overview]The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year
NCT02567825 (12) [back to overview]The Total Cost of Management of Recurrent Acute Otitis Media Per Quality Adjusted Life Days (QALDs) as a Measure of Cost-Effectiveness
NCT02567825 (12) [back to overview]The Time to the First Episode of AOM
NCT02567825 (12) [back to overview]The Total Cost of Management of Recurrent Acute Otitis Media Per Quality Adjusted Life Days (QALDs) as a Measure of Cost-Effectiveness According to the Estimated Risk of Acute Otitis Media Recurrences at Enrollment
NCT02605122 (4) [back to overview]Summary of Clinical Cure
NCT02605122 (4) [back to overview]Overview of Adverse Events By Treatment Arm
NCT02605122 (4) [back to overview]Summary of Early Clinical Response
NCT02605122 (4) [back to overview]Summary of Clinical Improvement
NCT02630992 (11) [back to overview]Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2
NCT02630992 (11) [back to overview]Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1
NCT02630992 (11) [back to overview]Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2
NCT02630992 (11) [back to overview]The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product
NCT02630992 (11) [back to overview]The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product
NCT02630992 (11) [back to overview]The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit
NCT02630992 (11) [back to overview]The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product
NCT02630992 (11) [back to overview]The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product
NCT02630992 (11) [back to overview]The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1
NCT02630992 (11) [back to overview]The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2
NCT02630992 (11) [back to overview]Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
NCT02724410 (4) [back to overview]Number of Participants With Wound Infections
NCT02724410 (4) [back to overview]Number Participants With Readmission Within 30 Days
NCT02724410 (4) [back to overview]Number of Participants With Postoperative Abscess
NCT02724410 (4) [back to overview]Hospital Charge
NCT02800785 (8) [back to overview]Days in Hospital After Index Treatment Within 90 Days
NCT02800785 (8) [back to overview]Rates of Participants With Appendiceal Cancer
NCT02800785 (8) [back to overview]Eventual Appendectomy Incidence Proportion
NCT02800785 (8) [back to overview]Number of Clinic Visits or Emergency Room Visits
NCT02800785 (8) [back to overview]Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days
NCT02800785 (8) [back to overview]Rate of Participants With Perforated Appendicitis
NCT02800785 (8) [back to overview]Patient-reported Quality of Life as Measured by EuroQol (EQ-5D)
NCT02800785 (8) [back to overview]Number of Participants With at Least One Complications From Treatment
NCT02891915 (10) [back to overview]Resolution of Symptoms (a Component of DOOR)
NCT02891915 (10) [back to overview]Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits
NCT02891915 (10) [back to overview]Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits
NCT02891915 (10) [back to overview]Adequate Clinical Response Rates (a Component of DOOR)
NCT02891915 (10) [back to overview]Adequate Clinical Response Rates (a Component of DOOR)
NCT02891915 (10) [back to overview]Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits
NCT02891915 (10) [back to overview]Resolution of Symptoms (a Component of DOOR)
NCT02891915 (10) [back to overview]Number of Participants Reporting Solicited Symptoms
NCT02891915 (10) [back to overview]Number of Participants Reporting Solicited Symptoms
NCT02891915 (10) [back to overview]Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits
NCT03174184 (5) [back to overview]Estimate the Antimycobacterial Activity Based on Liquid Culture Time-to-positivity
NCT03174184 (5) [back to overview]Estimate of the 14-day Early Bactericidal Activity (EBA), Based on Colony Forming Unit Counts, of the Combination of Meropenem and Amoxicillin/Clavulanate, Without Versus With Rifampin
NCT03174184 (5) [back to overview]Distribution of Minimum Inhibitory Concentration (MIC) of Rifampin
NCT03174184 (5) [back to overview]AUC for Rifampin
NCT03174184 (5) [back to overview]Frequency of Grade 2 or Higher Adverse Events
NCT03357614 (2) [back to overview]Percentage of Participants With Microbiologic Success
NCT03357614 (2) [back to overview]Percentage of Participants With Overall Success
NCT03358576 (2) [back to overview]Percentage of Participants With Clinical Success
NCT03358576 (2) [back to overview]Percentage of Participants With Clinical Success
NCT03755765 (5) [back to overview]Level of Fecal SCFA Butyrate
NCT03755765 (5) [back to overview]Level of Fecal SCFA Propionate
NCT03755765 (5) [back to overview]Level of Fecal Short-chain Fatty Acid (SCFA) Acetate
NCT03755765 (5) [back to overview]Change in Community Diversity (Shannon Diversity Index) From Post run-in Baseline
NCT03755765 (5) [back to overview]Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline
NCT03818815 (3) [back to overview]Evaluation of Efficacy (Otoscopy)
NCT03818815 (3) [back to overview]Number of Participants With Adverse Events
NCT03818815 (3) [back to overview]Evaluation of Efficacy (Otoscopy)
NCT04411914 (5) [back to overview]Changes in Resting State Network Connectivity From Baseline
NCT04411914 (5) [back to overview]Change in Brain Glutamine From Baseline
NCT04411914 (5) [back to overview]Brain Glutamate Concentration in the Anterior Cingulate Cortex (ACC) in Subjects With Cocaine Use Disorder (CUD) Treated With Escalating Doses of Clavulanate (CLAV)
NCT04411914 (5) [back to overview]Number of Participants With Treatment-related Adverse Events (AEs)
NCT04411914 (5) [back to overview]Craving

The Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment

This is the number of times, in the course of the study, a child required treatment with an antibiotic other than the blinded study medication. (NCT00377260)
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.

Interventionantibiotic prescriptions (Mean)
Amoxicillin-Clavulanate.35
Placebo.75

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The Mean Number of Visits to a Primary Care Provider (PCP) According to Treatment Assignment

At each visit parents were asked if they had taken their child to his/her primary care physician since the last contact. Medical records were also reviewed. (NCT00377260)
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.

Interventionvisits to PCP (Mean)
Amoxicillin-Clavulanate.15
Placebo.23

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The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the End-of-therapy Visit According to Treatment Assignment

Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5. (NCT00377260)
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.

Interventionparental satisfaction score (Mean)
Amoxicillin-Clavulanate4.40
Placebo4.12

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The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the Follow-up Visit According to Treatment Assignment

Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5. (NCT00377260)
Timeframe: Follow-up visit. The mean day for this visit was 22.8.

Interventionparental satisfaction score (Mean)
Amoxicillin-Clavulanate4.53
Placebo4.17

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The Mean Score Representing Parental Satisfaction With the Study Medication As Recorded at the On-therapy Visit According to Treatment Assignment

Parents were asked to circle the expression that best represented their satisfaction with the study medication. These expressions have an assigned value: Very dissatisfied = 1, Somewhat dissatisfied = 2, Neither satisfied nor dissatisfied = 3, Somewhat satisfied = 4 and Very satisfied = 5. (NCT00377260)
Timeframe: On-therapy visit. The mean day for this visit was 5.0.

Interventionparental satisfaction score (Mean)
Amoxicillin-Clavulanate4.19
Placebo4.13

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The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Having Missed Work According to Treatment Assignment

At each visit, parent or parents were asked if their child's illness had caused either parent to miss a day or partial day of work. The total number of visits is summed across all participants in the respective treatment arms. (NCT00377260)
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.

Interventionvisits (Number)
Amoxicillin-Clavulanate33
Placebo33

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The Total Number of Visits, Summed Across All Participants, at Which a Family Member Reported Making Special Daycare Arrangements According to Treatment Assignment

At each visit, parent or parents were asked if their child's illness had caused them to make alternative daycare arrangements. The total number of visits is summed across all participants in the respective treatment arms. (NCT00377260)
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.

Interventionvisits (Number)
Amoxicillin-Clavulanate22
Placebo24

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The Weighted Average Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, According to Treatment Assignment

The AOM-SOS score is derived from parent scoring each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) associated with AOM as 0, 1 or 2 (none, a little, a lot). The AOM-SOS was administered twice daily the first 3 days of follow-up, then daily for 4 additional days. Symptom burden for each child is determined by calculating the weighted average of symptom scores post-enrollment over the first 7 days of therapy. Scores are weighted by 1/k, where k is the number of post-enrollment assessments taken on that day. (NCT00377260)
Timeframe: During the first 7 days of therapy

InterventionAOM-SOS score (Mean)
Amoxicillin-Clavulanate2.79
Placebo3.42

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The Distribution of Children Developing Worsening Symptoms Prior to Receiving 72 Hours of Study Medication According to Treatment Assignment

The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1 and twice daily Days 2 and 3. Each set of ratings was summed to obtain an Acute Otitis Media-Severity of Symptoms (AOM-SOS) score. We compared a child's AOM-SOS scores in the first 72 hours to his/her score at enrollment to determine if a child's symptoms got worse (score increased) or remained unchanged or improved (score remained same or decreased). (NCT00377260)
Timeframe: Before receiving 72 hours of study medication

,
InterventionParticipants (Number)
Number of children with worsening symptomsNumber of children unchanged or improved
Amoxicillin-Clavulanate31112
Placebo39104

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The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the End-of-therapy Visit According to Treatment Assignment

AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the end of therapy visit. (NCT00377260)
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.

,
Interventionparticipants (Number)
Presence of at least one AOM pathogenAbsence of any AOM pathogenPresence of Streptococcus pneumoniaeAbsence of Streptococcus pneumoniaePresence of Haemophilus influenzaeAbsence of Haemophilus influenzaePresence of Moraxella catarrhalisAbsence of Moraxella catarrhalisPresence of Streptococcus pyogenesAbsence of Streptococcus pyogenes
Amoxicillin-Clavulanate636718112458591210130
Placebo88434685448738933128

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The Distribution of Children With Nasopharyngeal (NP) Colonization With AOM Pathogens at the Follow-up Visit According to Treatment Assignment

AOM pathogens are defined as Streptococcus Pneumoniae or Haemophilus Influenzae or Moraxella Catarrhalis or Streptococcus Pyogenes. Nasopharyngeal cultures were obtained at the follow-up visit. (NCT00377260)
Timeframe: Follow-up visit. The mean day for this visit was 22.8.

,
Interventionparticipant (Number)
Presence of at least one AOM pathogenAbsence of any AOM pathogenPresence of Streptococcus pneumoniaeAbsence of Streptococcus pneumoniaePresence of Haemophilus influenzaeAbsence of Haemophilus influenzaePresence of Moraxella catarrhalisAbsence of Moraxella catarrhalisPresence of Streptococcus pyogenesAbsence of Streptococcus pyogenes
Amoxicillin-Clavulanate765226102389029991127
Placebo89414288389231990130

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The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the End-of-therapy Visit According to Treatment Assignment

(NCT00377260)
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.

,
Interventionparticipants (Number)
Colonization with penicillin-susceptible S. pnNo colonization with penicillin-susceptible S. pn
Amoxicillin-Clavulanate1129
Placebo28102

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The Distribution of Children With Nasopharyngeal (NP) Colonization With Penicillin-susceptible Streptococcus Pneumoniae (S. pn) at the Follow-up Visit

(NCT00377260)
Timeframe: Follow-up visit. The mean day for this visit was 22.8.

,
Interventionparticipants (Number)
Colonization with penicillin-susceptible S. pnNo colonization with penicillin-susceptible S. pn
Amoxicillin-Clavulanate7121
Placebo17112

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The Distribution of Children With Observed or Parent Reported Adverse Events or Complications According to Treatment Assignment

Analysis was limited to those adverse events identified as being associated with either the study medication or the antimicrobials administered to children who were treatment failures or as being a complication of acute otitis media. (NCT00377260)
Timeframe: We monitored children and queried parents regarding adverse events at each study visit, i.e. Day 4-5, Day 10-12, and Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this visit was 22.8.

,
Interventionparticipants (Number)
MastoiditisPerforation of tympanic membraneProtocol-defined diarrheaDiaper dermatitisOral thrushVomitingRash
Amoxicillin-Clavulanate0136737121
Placebo1722511122

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The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the Follow-up Visit According to Treatment Assignment

For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE. (NCT00377260)
Timeframe: Follow-up visit. The mean day for this visit was 22.8.

,
Interventionprobability of effusion (Mean)
Right earLeft ear
Amoxicillin-Clavulanate.28.27
Placebo.32.37

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The Mean Number of Emergency Room Visits According to Treatment Assignment

At each visit we asked parents if they had to take their child to the emergency department. We also reviewed medical records to assure even more accurate reporting. (NCT00377260)
Timeframe: This was assessed at each study visit, i.e. Day 4-5, Day 10-12, Day 21-25, and at interim visits. The last assessment was made at the Day 21-25 visit. The mean day for this latter visit was 22.8.

Interventionvisits to ER (Mean)
Amoxicillin-Clavulanate.07
Placebo.07

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The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the On-therapy Visit According to Treatment Assignment

For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE. (NCT00377260)
Timeframe: On-therapy visit. The mean day for this visit was 5.0.

,
Interventionprobability of effusion (Mean)
Right earLeft ear
Amoxicillin-Clavulanate.36.39
Placebo.42.48

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The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1 on Two Consecutive Occasions, According to Treatment Assignment

Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches <= 1 on two consecutive occasions. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) & recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 & 3, & once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible was 14 and the minimum 0. A score >=3 was required to be enrolled in the study. (NCT00377260)
Timeframe: The first 7 days on therapy

,
Interventionparticipants (Number)
Resolved by Day 1 - PMCensored by Day 1 - PMResolved by Day 2 - AMCensored by Day 2 - AMResolved by Day 2 - PMCensored by Day 2 - PMResolved by Day 3 - AMCensored by Day 3 - AMResolved by Day 3 - PMCensored by Day 3 - PMResolved by Day 4Censored by Day 4Resolved by Day 5Censored by Day 5Resolved by Day 6Censored by Day 6Resolved by Day 7Censored by Day 7
Amoxicillin-Clavulanate011712913415015817018019648
Placebo02822032934245156356957671

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The Time to Resolution of Symptoms, Defined as Acute Otitis Media-Severity of Symptoms (AOM-SOS) Score of 0 or 1, According to Treatment Assignment

Time to resolution of symptoms is defined as the time from randomization until a child's AOM-SOS score reaches 0 or 1. The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score. The maximum possible score was 14 and the minimum was 0. A score >=3 was required to be enrolled in the study. (NCT00377260)
Timeframe: The first 7 days on therapy

,
Interventionparticipants (Number)
Resolved by Day 1 - PMCensored by Day 1 - PMResolved by Day 2 - AMCensored by Day 2 - AMResolved by Day 2 - PMCensored by Day 2 - PMResolved by Day 3 - AMCensored by Day 3 - AMResolved by Day 3 - PMCensored by Day 3 - PMResolved by Day 4Censored by Day 4Resolved by Day 5Censored by Day 5Resolved by Day 6Censored by Day 6Resolved by Day 7Censored by Day 7
Amoxicillin-Clavulanate201381501701771871961110111430
Placebo9228241358366478492498410641

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The Probability of Middle Ear Effusion, Based on an Algorithm That Estimates the Probability of Middle Ear Effusion From an Interpretable Tympanographic Configuration, at the End-of-therapy Visit According to Treatment Assignment

For tympanograms with values for height, middle-ear air pressure, and gradient width, the probability of Middle Ear Effusion (MEE) was estimated by applying an algorithm developed by Smith et al. If the tympanogram was flat and had no printed values for the 3 fields, the probability of MEE was estimated to be .802 based on the proportion of ears with flat graphs that were found otoscopically, by Smith et al, to have MEE. (NCT00377260)
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.

,
Interventionprobability of effusion (Mean)
Right earLeft ear
Amoxicillin-Clavulanate.32.33
Placebo.41.41

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The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Score, Post-enrollment, Over the First 7 Days of Therapy According to Treatment Assignment

The parent rated each of 7 symptoms (ear tugging, crying, irritability, difficulty sleeping, diminished activity, diminished appetite & fever) as 0, 1 or 2 (none, a little, a lot) and recorded the ratings in a diary following enrollment on Day 1, twice daily Days 2 and 3, then once daily Days 4-7. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. The maximum possible score was 14 and the minimum was 0. (NCT00377260)
Timeframe: During the first 7 days of therapy

,
InterventionAOM-SOS score (Mean)
Day 1 PMDay 2 AMDay 2 PMDay 3 AMDay 3 PMDay 4Day 5Day 6Day 7
Amoxicillin-Clavulanate5.804.123.782.862.822.401.931.401.28
Placebo6.204.854.333.373.252.682.412.311.94

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The Mean Number of Times Analgesic Medication Was Administered to the Child According to Treatment Assignment

The parents were asked to complete a memory aid for the first 10 days of the study. One item asked them to record medications administered to the child in addition to the study medication. The data presented shows the mean number of times analgesic, i.e. ibuprofen or acetaminophen, was administered. (NCT00377260)
Timeframe: The first 10 days of follow-up

Interventiontimes analgesic was administered (Mean)
Amoxicillin-Clavulanate.37
Placebo.43

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The Distribution of Clinical Failures by the On-therapy Visit According to Treatment Assignment

Clinical failure by the on-therapy visit is defined as either failure to achieve substantial improvement in symptoms, or worsening of otoscopic signs, or both. (NCT00377260)
Timeframe: On-therapy visit. The mean day for this visit was 5.0.

,
Interventionparticipants (Number)
Clinical failures by the on therapy visitSubjects not classified as clinical failures
Amoxicillin-Clavulanate5138
Placebo34111

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The Distribution of Clinical Failures by the End-of-therapy Visit According to Treatment Assignment

Clinical failure by the end of therapy visit is defined as failure to achieve complete or virtually complete resolution of symptoms and of otoscopic signs, but without regard to the persistence of middle ear effusion. (NCT00377260)
Timeframe: End-of-therapy visit. The mean day for this visit was 11.6.

,
Interventionparticipants (Number)
Clinical failures by the end of therapy visitSubjects not classified as clinical failures
Amoxicillin-Clavulanate23119
Placebo7370

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Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the Microbiological Valid (MBV) Population

Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism. (NCT00402727)
Timeframe: 3 - 5 days after start of treatment

Interventionpercentage of participants (Number)
Moxifloxacin55.2
PIP/TAZ-AMC63.8

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Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the ITT Population With Causative Organisms

Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism. (NCT00402727)
Timeframe: after 7 - 21 days of treatment

Interventionpercentage of participants (Number)
Moxifloxacin84.0
PIP/TAZ-AMC87.9

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Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the Microbiological Valid (MBV) Population

BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment. (NCT00402727)
Timeframe: 14 - 28 days after last dose of study medication

Interventionpercentage of participants (Number)
Moxifloxacin84.3
PIP/TAZ-AMC87.2

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Percentage of Participants With Bacteriological Success (BS) After 14 - 28 Days After Last Dose of Study Medication in the ITT Population With Causative Organisms

BS is presumed eradication or eradication without recurrence, super- or reinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study; super-, reinfection as appearance of a new organism during/after treatment. (NCT00402727)
Timeframe: 14 - 28 days after last dose of study medication

Interventionpercentage of participants (Number)
Moxifloxacin78.9
PIP/TAZ-AMC79.0

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Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Per Protocol (PP) Population

"Clinical response was evaluated by the investigator and graded as resolution, or failure to respond, or indeterminate at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs." (NCT00402727)
Timeframe: after 7 - 21 days of treatment

Interventionpercentage of participants (Number)
Moxifloxacin95.3
PIP/TAZ-AMC95.1

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Percentage of Participants Assessed as Resolution by the Data Review Committee (DRC) at End of Therapy in the Intent to Treat (ITT) Population

"Clinical response was evaluated by the investigator and graded as resolution, or failure to respond, or indeterminate at the end of therapy based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs." (NCT00402727)
Timeframe: after 7 - 21 days of treatment

Interventionpercentage of participants (Number)
Moxifloxacin92.3
PIP/TAZ-AMC90.7

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Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Per Protocol (PP) Population

"Clinical response was evaluated by the investigator and graded as improvement in signs and symptoms, or failure to respond, or indeterminate at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs." (NCT00402727)
Timeframe: 3 - 5 days after start of treatment

Interventionpercentage of participants (Number)
Moxifloxacin98.3
PIP/TAZ-AMC99.0

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Percentage of Participants Assessed as Improvements by the Data Review Committee (DRC) at the During Treatment Day 3-5 in the Intent to Treat (ITT) Population

"Clinical response was evaluated by the investigator and graded as improvement in signs and symptoms, or failure to respond, or indeterminate at Day 3 to 5 after treatment start based on subject data for clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs" (NCT00402727)
Timeframe: 3 - 5 days after start of treatment

Interventionpercentage of participants (Number)
Moxifloxacin97.2
PIP/TAZ-AMC95.8

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Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Per Protocol (PP) Population

"Clinical response was evaluated by the DRC and graded as cure, failure or indeterminate at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs." (NCT00402727)
Timeframe: 14 - 28 days after last dose of study medication

Interventionpercentage of participants (Number)
Moxifloxacin88.6
PIP/TAZ-AMC89.6

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Percentage of Cured Participants as Determined by the Data Review Committee (DRC) at Test of Cure Visit in the Intent to Treat (ITT) Population

"Clinical response was evaluated by the DRC and graded as cure, failure or indeterminate at the TOC visit. Members of the DRC were provided with subject data from the study database that included clinical signs and symptoms at each visit, concomitant medication, microbiology results, laboratory tests and interpretation of photographs." (NCT00402727)
Timeframe: 14 - 28 days after last dose of study medication

Interventionpercentage of participants (Number)
Moxifloxacin82.2
PIP/TAZ-AMC80.9

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Percentage of Participants With Bacteriological Success (BS) at 3 to 5 Days After Start of Treatment in the ITT Population With Causative Organisms

Bacteriological success was defined as presumed eradication or eradication without superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, superinfection as appearance of a new organism. (NCT00402727)
Timeframe: 3 - 5 days after start of treatment

Interventionpercentage of participants (Number)
Moxifloxacin54.6
PIP/TAZ-AMC63.1

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Percentage of Participants With Bacteriological Success (BS) After 7 - 21 Days of Treatment in the Microbiological Valid (MBV) Population

Bacteriological success is presumed eradication or eradication without recurrence or superinfection. Presumed eradication was defined as clinical cure in absence of a culture, eradication as a negative culture, recurrence as reappearance of organism present at start of study, superinfection as appearance of a new organism. (NCT00402727)
Timeframe: after 7 - 21 days of treatment

Interventionpercentage of participants (Number)
Moxifloxacin85.8
PIP/TAZ-AMC91.4

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Total Healthcare Visits

(NCT00462020)
Timeframe: 1 month

InterventionVisits (Mean)
IV Only3.1
IV and Oral Abx3.1

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Length of Stay After Operation

(NCT00462020)
Timeframe: 1 month

InterventionDays (Mean)
IV Only6.06
IV and Oral Abx4.48

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Abscess After Appendectomy

(NCT00462020)
Timeframe: 1 month

Interventionnumber of patients (Number)
IV Only10
IV and Oral Abx10

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Operative Time

(NCT00462020)
Timeframe: 1 month

InterventionMinutes (Mean)
IV Only41.06
IV and Oral Abx46.30

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Time to Regular Diet

(NCT00462020)
Timeframe: 1 month

InterventionHours (Mean)
IV Only68.00
IV and Oral Abx61.42

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Number of Participants With Response (Microbiologically Valid Patients)

Bacteriological Efficacy Rate at the 'Test-of-Cure' visit, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication. (NCT00493038)
Timeframe: At 'Test-of-Cure', Day 1-3 after treatment

,
InterventionParticipants (Number)
Bacteriological successFailure
Amoxicillin/Clavulanate251
Moxifloxacin (Avelox, BAY12-8039)210

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Number of Participants With Response (Per-protocol Population)

"Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 24-30 days after treatment was assessed by the investigator as continued clinical cure" (NCT00493038)
Timeframe: End of Follow-up, Day 24-30 after treatment

Interventionparticipants (Number)
Moxifloxacin (Avelox, BAY12-8039)108
Amoxicillin/Clavulanate117

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Number of Participants With Response (Microbiologically Valid Patients)

Bacteriological Efficacy Rate at the End of Follow-up period, measured in patients defined as 'microbiologically valid'. A bacteriological success is an eradication without super- or reinfection or presumed eradication. (NCT00493038)
Timeframe: End of Follow-up, Day 24-30 after treatment

,
InterventionParticipants (Number)
Bacteriological successFailureMissing / Indeterminate
Amoxicillin/Clavulanate2303
Moxifloxacin (Avelox, BAY12-8039)1902

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Number of Participants With Response (Per-protocol Population)

"Number of patients in the population who met criteria pre-specified in the protocol whose clinical response 1-3 days after treatment was assessed by the investigator as clinical cure" (NCT00493038)
Timeframe: At 'Test-of-Cure', Day 1-3 after treatment

Interventionparticipants (Number)
Moxifloxacin (Avelox, BAY12-8039)119
Amoxicillin/Clavulanate125

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Number of Participants With Response (Intent-to-treat Population)

"Number of patients in the population who received at least one dose of study medication whose clinical response 1-3 days after treatment was assessed by the investigator as clinical cure" (NCT00493038)
Timeframe: At 'Test-of-Cure', Day 1-3 after treatment

Interventionparticipants (Number)
Moxifloxacin (Avelox, BAY12-8039)128
Amoxicillin/Clavulanate127

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Number of Patients Who Were Cured

Cure defined as the disappearance of the acute signs and symptoms related to the infection, with complete return to the previous situation of stability (NCT00495586)
Timeframe: Day 9-11

InterventionParticipants (Number)
Placebo91
Amoxycillin and Clavulanic Acid117

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Number of Participants With Microbiological Response at Test of Cure (TOC) Visit

Microbiological response assessed at participant level. Eradication=the absence of the original pathogens from the post-treatment TOC culture of specimen from the original site of infection. Presumed eradication=the complete resolution of signs and symptoms associated with cessation of culturable specimen (for example, sputum). Persistence=the presence of the original pathogen in the post-treatment TOC culture specimen from the original site of infection. Presumed persistence=in a participant who was judged to be a clinical failure and a culture of specimen was not possible or was not done, it was presumed that there was persistence of the pathogen. Not applicable microbiologic response included participants that did not have post-treatment microbiologic cultures due to early discontinuation. Data reported for eradication is combination of eradication and presumed eradication data and data reported for persistence is combination of persistence and presumed persistence data. (NCT00797108)
Timeframe: 7 to 14 days after EOT

,,
Interventionparticipants (Number)
EradicationPersistenceNot Applicable
Ceftriaxone and Amoxicillin/Clavulanate301
Sulopenem (Multi Intravenous Dose) and PF-03709270401
Sulopenem (Single Intravenous Dose) and PF-03709270400

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Percentage of Participants With Clinical Response at End of Treatment (EOT) and Follow-up Visit

"CR was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At EOT (Day 7 to 10) and follow-up (15 to 28 days after EOT), CR was evaluated as cure=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; failure=persistence or progression of baseline signs and symptoms of pneumonia, development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; with additional CR evaluated as improvement= of few not all signs and symptoms of pneumonia when compared to baseline and no additional antibacterial treatment required at EOT and indeterminate=extenuating circumstances precluded classification to 1 of the above at follow-up." (NCT00797108)
Timeframe: EOT (Day 7 to 10) , Follow-up (15 to 28 days after EOT)

,,
Interventionpercentage of participants (Number)
EOT: CureEOT: ImprovementEOT: FailureFollow-up: CureFollow-up: FailureFollow-up: Indeterminate
Ceftriaxone and Amoxicillin/Clavulanate75.012.512.562.512.525.0
Sulopenem (Multi Intravenous Dose) and PF-0370927075.025.00.087.50.012.5
Sulopenem (Single Intravenous Dose) and PF-0370927060.030.010.090.00.010.0

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Number of Participants With Abnormal Physical Examination Findings

A physical examination included an examination of the general appearance, skin, heart, head, eyes, ears, nose, throat, breasts, abdomen, musculoskeletal, neck, neurological, extremities, and others. Criteria for abnormal physical findings were based on investigator's discretion. (NCT00797108)
Timeframe: Last observation (up to 15-28 days after EOT, approximately 38 days)

Interventionparticipants (Number)
Sulopenem (Single Intravenous Dose) and PF-037092700
Sulopenem (Multi Intravenous Dose) and PF-037092701
Ceftriaxone and Amoxicillin/Clavulanate0

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Percentage of Participants With Clinical Response at Test of Cure (TOC) Visit

"Clinical response (CR) was based primarily on global assessment of clinical presentation of participant made by investigator at evaluation time point. At TOC (7 to 14 days after end of treatment [EOT]) CR was evaluated as cure=resolution of clinical signs and symptoms related to the acute infection, or clinical improvement in which no additional antibiotics were deemed necessary when compared to baseline; failure=persistence or progression of baseline signs and symptoms of pneumonia (for example: body temperature, white blood cell [WBC] count, respiratory rate, auscultatory findings, cough, sputum production), development of new pulmonary or extrapulmonary clinical findings consistent with active infection and those participants that were not assessed for clinical response due to early discontinuation; indeterminate=extenuating circumstances precluded classification to 1 of the above." (NCT00797108)
Timeframe: 7 to 14 days after end of treatment

,,
Interventionpercentage of participants (Number)
CureFailureIndeterminate
Ceftriaxone and Amoxicillin/Clavulanate62.525.012.5
Sulopenem (Multi Intravenous Dose) and PF-0370927087.512.50
Sulopenem (Single Intravenous Dose) and PF-0370927090.010.00

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Number of Participants Who Died

(NCT00797108)
Timeframe: Baseline up to 15 to 28 days after EOT

Interventionparticipants (Number)
Sulopenem (Single Intravenous Dose) and PF-037092700
Sulopenem (Multi Intravenous Dose) and PF-037092700
Ceftriaxone and Amoxicillin/Clavulanate0

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Number of Participants With Abnormal Laboratory Test Findings

Criteria for laboratory abnormalities: hemoglobin (Hb), hematocrit, red blood cell (RBC) (less than [<] 0.8*lower limit of normal [LLN]); reticulocyte (absolute and percentage) (<0.5*LLN or greater than [>] 1.5*upper LN [ULN]); platelet (<0.5*LLN or >1.75*ULN); white blood cell (WBC) (<0.6*LLN or >1.5*ULN); lymphocyte, neutrophil (<0.8*LLN or >1.2*ULN); eosinophil, monocyte, basophil (>1.2*ULN); bilirubin (BR) (>1.5*ULN); aspartate and alanine aminotransferase, gamma-glutamyl transpeptidase, alkaline phosphatase, lactate dehydrogenase (>3.0*ULN); total protein, albumin (<0.8*LLN or >1.2*ULN);blood urea nitrogen, creatinine (>1.3*ULN); sodium (<0.95*LLN or >1.05*ULN); potassium, chloride, calcium, magnesium, bicarbonate (<0.9*LLN or >1.1*ULN); glucose (<0.6*LLN or >1.5*ULN); urine (pH [<4.5 or >8], glucose, protein, blood, ketone [>=1]). Total number of participants with abnormal laboratory values were reported. (NCT00797108)
Timeframe: Baseline up to 15 to 28 days after EOT

Interventionparticipants (Number)
Sulopenem (Single Intravenous Dose) and PF-037092707
Sulopenem (Multi Intravenous Dose) and PF-037092708
Ceftriaxone and Amoxicillin/Clavulanate9

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Change From Baseline in Community Acquired Pneumonia (CAP) Symptom Questionnaire at Test of Cure (TOC) and Follow-up Visit

The CAP Symptom Questionnaire was a participant reported questionnaire administered by interview. It consisted of 12 items (coughing, chest pains, shortness of breath, sweating, chills, headache, nausea, muscle pain, lack of appetite, trouble concentrating, trouble sleeping, and fatigue). Depending on if the participant had or not had symptoms/problems, they were asked how much they had been bothered by the symptoms/problems over the previous 24 hours. CAP items were rated on the 6-point response scale (0 = participant did not have symptom/problem: 1 = not at all, 2 = a little, 3 = moderately, 4 = quite a bit, 5 = extremely; if the participant had the symptom/problem and were bothered). All 12 items score were summed and averaged to produce a CAP symptom score (range, 0 to 6). High values indicated poorer outcomes (higher symptom bothersomeness). (NCT00797108)
Timeframe: Baseline, TOC (7 to 14 days after end of treatment), Follow-up (15 to 28 days after EOT)

,,
Interventionunits on a scale (Mean)
Baseline (n=10, 8, 8)Change at TOC (n=9, 7, 6)Change at Follow-up Visit (n=10, 8, 8)
Ceftriaxone and Amoxicillin/Clavulanate2.57-1.74-1.52
Sulopenem (Multi Intravenous Dose) and PF-037092702.75-2.02-1.89
Sulopenem (Single Intravenous Dose) and PF-037092702.17-1.43-1.39

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Number of Participants With Categorical Change From Baseline in Vital Signs

Participants who met the categorical criteria for increase in vital signs data were reported. Categorical criteria for increase from baseline vital signs data: supine and sitting systolic blood pressure (BP) of greater than or equal to (>=) 30 millimeter of mercury (mmHg); supine and sitting diastolic BP of >=20 mmHg. (NCT00797108)
Timeframe: Baseline up to 15 to 28 days after EOT

,,
Interventionparticipants (Number)
Supine Systolic BP >=30 mmHg (n=3, 5, 4)Sitting Systolic BP >=30 mmHg (n=7, 6, 6)Supine Diastolic BP >=20 mmHg (n=3, 5, 4)Sitting Diastolic BP >=20 mmHg (n=7, 6, 6)
Ceftriaxone and Amoxicillin/Clavulanate1120
Sulopenem (Multi Intravenous Dose) and PF-037092702121
Sulopenem (Single Intravenous Dose) and PF-037092700204

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Number of Participants With Surgical Site Infections

(NCT00801099)
Timeframe: within 30 days postoperative

Interventionparticipants (Number)
Amoxicillin/Clavulanic Acid11

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AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin

Bioequivalence based on AUC0-inf (NCT00835705)
Timeframe: Blood samples were collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid19089.36
Augmentin®19395.97

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AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavulanic Acid

Bioequivalence based on AUC0-inf (NCT00835705)
Timeframe: Blood samples collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid2876.99
Augmentin®2833.74

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AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin

Bioequivalence based on AUC0-t (NCT00835705)
Timeframe: Blood samples were collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid18939.13
Augmentin®19263.26

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AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Clavulanic Acid

Bioequivalence based on AUC0-t (NCT00835705)
Timeframe: Blood samples collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid2798.69
Augmentin®2749.12

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Cmax (Maximum Observed Concentration) - Clavulanic Acid

Bioequivalence based on Cmax (NCT00835705)
Timeframe: Blood samples collected over 10 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanic Acid1483.32
Augmentin®1449.68

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Cmax (Maximum Observed Concentration) - Amoxicillin

Bioequivalence based on Cmax (NCT00835705)
Timeframe: Blood samples were collected over 10 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanic Acid7800.48
Augmentin®7599.29

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AUC0-t [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant) - Clavulanic Acid

Bioequivalence based on AUC0-t (NCT00836901)
Timeframe: Blood samples collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid1693.67
Augmentin®1785.27

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AUC0-t - [Area Under the Concentration-time Curve From Time Zero to Time of Last Non-zero Concentration (Per Participant)] - Amoxicillin

Bioequivalence based on AUC0-t (NCT00836901)
Timeframe: Blood samples collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid18299.44
Augmentin®18746.55

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AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic Acid

Bioequivalence based on AUC0-inf (NCT00836901)
Timeframe: Blood samples collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid1772.85
Augmentin®1864.33

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AUC0-inf - [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Amoxicillin

Bioequivalence based on AUC0-inf (NCT00836901)
Timeframe: Blood samples collected over 10 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanic Acid19403.12
Augmentin®19518.22

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Cmax (Maximum Observed Concentration) - Clavulanic Acid

Bioequivalence based on Cmax (NCT00836901)
Timeframe: Blood samples were collected over 10 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanic Acid734.20
Augmentin®766.38

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Cmax (Maximum Observed Concentration) - Amoxicillin

Bioequivalence based on Cmax (NCT00836901)
Timeframe: Blood samples collected over 10 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanic Acid4482.26
Augmentin®4549.67

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Bioequivalence Based on Cmax for Amoxicillin

Cmax - Maximum Observed Concentration (NCT00840099)
Timeframe: Blood samples collected over 14 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanate10970.75
AugmentinES-600™10867.32

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Bioequivalence Based on AUC0-inf for Amoxicillin

AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00840099)
Timeframe: Blood samples collected over 14 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanate27965.57
AugmentinES-600™27147.08

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Bioequivalence Based on AUC0-inf for Clavulanic Acid

AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00840099)
Timeframe: Blood samples collected over 14 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanate2396.58
AugmentinES-600™2260.40

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Bioequivalence Based on AUC0-t for Amoxicillin

AUC0-t - Area under the concentration-time curve from time zero to the time of last non-zero concentration (NCT00840099)
Timeframe: Blood samples collected over 14 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanate27464.27
AugmentinES-600™26666.90

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Bioequivalence Based on AUC0-t for Clavulanic Acid

AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (NCT00840099)
Timeframe: Blood samples collected over 14 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanate2293.69
AugmentinES-600™2157.07

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Bioequivalence Based on Cmax for Clavulanic Acid

Cmax - Maximum Observed Concentration (NCT00840099)
Timeframe: Blood samples collected over 14 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanate1127.59
AugmentinES-600™1106.84

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Bioequivalence Based on Cmax for Clavulanic Acid

Cmax - Maximum Observed Concentration (NCT00840840)
Timeframe: Blood samples collected over 14 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanate516.42
AugmentinES-600™507.38

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Bioequivalence Based on AUC0-inf for Amoxicillin

AUC0-inf - Area under the concentration-time curve from time zero to infinity (extrapolated) (NCT00840840)
Timeframe: Blood samples collected over 14 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanate27318.54
AugmentinES-600™26515.59

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Bioequivalence Based on AUC0-inf for Clavulanic Acid

AUC0-inf - Area under the concentration-time curve from zero to infinity (extrapolated) (NCT00840840)
Timeframe: Blood samples collected over 14 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanate1335.73
AugmentinES-600™1283.73

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Bioequivalence Based on Cmax for Amoxicillin

Cmax - Maximum Observed Concentration (NCT00840840)
Timeframe: Blood samples collected over 14 hour period

Interventionng/mL (Mean)
Amoxicillin Clavulanate7331.46
AugmentinES-600™7235.76

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Bioequivalence Based on AUC0-t for Clavulanic Acid

AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (NCT00840840)
Timeframe: Blood samples collected over 14 hour period

Interventionng/h/mL (Mean)
Amoxicillin Clavulanate1241.09
AugmentinES-600™1195.82

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Bioequivalence Based on AUC0-t for Amoxicillin

AUC0-t - Area under the concentration-time curve from time zero to time of last non-zero concentration (NCT00840840)
Timeframe: Blood samples collected over 14 hour period

Interventionng*h/mL (Mean)
Amoxicillin Clavulanate26662.17
AugmentinES-600™25906.24

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Corrected QT (QTc) Interval Calculated (Calc) Bazett Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

"QTc interval Calc Bazett represent the interval corrected for heart rate (QTc) milliseconds (msec) which was calculated by Bazett's method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
Interventionmilliseconds (Mean)
Day 1: Pre-dose (N= 298, 150)Change at Day 1 (N= 290, 148)Day 3: Pre-dose (N= 292, 146)Change at Day 3 (N= 287, 146)
Comparator Ertapenem417.342.2905412.79451
Moxifloxacin (Avelox, BAY12-8039)419.58729.731419.20559.2509

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Corrected QT (QTc) Interval Calculated (Calc) Fridericia Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

"QTc interval Calc Fridericia represent the interval corrected for heart rate (QTc) msec which was calculated by Fridericia's method. N signifies subjects who were evaluable for the specified parameter for each arm, respectively." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
Interventionmilliseconds (Mean)
Day 1: Pre-dose (N= 298, 150)Change at Day 1 (N= 290, 148)Day 3: Pre-dose (N= 292, 146)Change at Day 3 (N= 287, 146)
Comparator Ertapenem390.94671.9122392.69181.774
Moxifloxacin (Avelox, BAY12-8039)391.18467.0724397.37678.115

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Heart Rate Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

"N signifies subjects who were evaluable for the specified parameter for each arm, respectively." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
InterventionBeats per minute (bpm) (Mean)
Day 1: Pre-dose (N= 300, 150)Change at Day 1 ((N= 294, 148)Day 3: Pre-dose (N= 293, 146)Change at Day 3 (N= 290, 146)
Comparator Ertapenem90.40.382.6-0.9
Moxifloxacin (Avelox, BAY12-8039)93.42.884.31

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Incidence Rates of Musculoskeletal Adverse Events by Primary System Organ Class (SOC) and Preferred Term

"Musculoskeletal adverse events were classified as following SOCs (preferred terms): injury, poisoning and procedural complications (forearm fracture, joint injury, ligament sprain, muscle strain) musculoskeletal and connective tissue disorders (arthralgia, joint swelling, musculoskeletal pain, myalgia). Incidence rates were reported as percentage of subjects categorized under preferred terms." (NCT01069900)
Timeframe: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

,
InterventionPercentage of subjects (Number)
Forearm fractureJoint injuryLigament sprainMuscle strainArthralgiaJoint swellingMusculoskeletal painMyalgia
Comparator Ertapenem00.70.70.71.30.700
Moxifloxacin (Avelox, BAY12-8039)0.300.303010.3

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Number of Subjects With Clinical Cardiac Adverse Events

(NCT01069900)
Timeframe: Clinical cardiac event related to QT interval were recorded from treatment start until day 3 of treatment. All other clinical cardiac events were recorded from treatment start to test of cure visit, up to day 56.

,
InterventionSubjects (Number)
Any AEAny SAE
Comparator Ertapenem70
Moxifloxacin (Avelox, BAY12-8039)380

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Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)

Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported (NCT01069900)
Timeframe: 28 to 42 days

,
InterventionPercentage of subjects (Number)
Clinical CureClinical FailureIndeterminate
Comparator Ertapenem95.322.7
Moxifloxacin (Avelox, BAY12-8039)86.25.78.1

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Bacteriological Response at a 'During Therapy' Visit

Bacteriological response during therapy were graded as presumed persistence, presumed eradication, or indeterminate'Presumed persistence' is applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation;'presumed eradication' is defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate is applicable when the bacteriological response to the study drug is not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject is not judged a clinical failure). Percentage of subjects with bacteriological response during therapy visit were reported (NCT01069900)
Timeframe: Day 3 to Day 5

,
InterventionPercentage of subjects (Number)
Presumed PersistencePresumed EradicationIndeterminate
Comparator Ertapenem0.797.81.5
Moxifloxacin (Avelox, BAY12-8039)1.295.63.2

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Bacteriological Response at Test-of-Cure (TOC) Visit

"Bacteriological responses were graded as presumed persistence, presumed eradication or indeterminate.~'Presumed persistence' was applicable for subjects judged to be clinical failures, and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded and invasive procedures are not warranted; índeterminate' was applicable when the bacteriological response to the study drug was not valid for any reason (eg, pre-treatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at TOC were reported." (NCT01069900)
Timeframe: 28 to 42 days

,
InterventionPercentage of subjects (Number)
Presumed PersistencePresumed EradicationIndeterminate
Comparator Ertapenem2.294.92.9
Moxifloxacin (Avelox, BAY12-8039)6.884.78.4

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Bacteriological Response at the End of Treatment (EOT) Visit

Bacteriological response at EOT were grades as presumed persistence, presumed eradication or indeterminate. 'presumed persistence' was applicable for subjects judged to be clinical failures and appropriate culture material is not available for evaluation; 'presumed eradication' defined as the absence of appropriate culture material for evaluation because the subject has clinically responded (with a response as a resolution or cure) and invasive procedures are not warranted; 'indeterminate' is applicable when the bacteriological response to the study drug was not valid for any reason (eg, pretreatment culture was negative or culture was not obtained when material was available and the subject was not judged a clinical failure). Percentage of subjects with bacteriological response at EOT were reported. (NCT01069900)
Timeframe: Day 5 to Day 14

,
InterventionPercentage of subjects (Number)
Presumed PersistencePresumed EradicationIndeterminate
Comparator Ertapenem0.797.81.5
Moxifloxacin (Avelox, BAY12-8039)5.591.13.4

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Clinical Response at a 'During Therapy' Visit

"Clinical responses during therapy visit were graded as clinical improvement, clinical failure, or indeterminate. Clinical improvement defined as a reduction in the severity and/or the number of signs and symptoms of infection; 'clinical failure' defined as a failure to respond or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy.~'Indeterminate' defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent, receipt of an effective concomitant antibacterial for an indication other than the study indication and receipt of less than 3 full days of study drug, etc). Percentage of subjects with clinical response during therapy visit were reported." (NCT01069900)
Timeframe: Day 3 to Day 5

,
InterventionPercentage of subjects (Number)
Clinical ImprovementClinical FailureIndeterminate
Comparator Ertapenem980.71.4
Moxifloxacin (Avelox, BAY12-8039)94.314.7

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Clinical Response at Test-of-Cure (TOC) Visit

Clinical responses were graded as clinical cure, failure or indeterminate. 'Clinical cure' defined as a resolution or sufficient improvement of clinical signs and symptoms related to the infection; 'failure' defined as a reappearance of the signs and symptoms of the original infection, or wound infection requiring further systemic antimicrobial therapy; 'indeterminate' defined as those subjects in whom a clinical assessment was not possible to determine (due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent). Percentage of subjects with clinical response at TOC were reported. (NCT01069900)
Timeframe: 28 to 42 days

,
InterventionPercentage of subjects (Number)
Clinical CureClinical FailureIndeterminate
Comparator Ertapenem95.322.7
Moxifloxacin (Avelox, BAY12-8039)86.25.78.1

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Number of Subjects With Adverse Events

An adverse event (AE) was any untoward medical occurrence in a subject who received study drug without regard to possibility of causal relationship. An serious adverse event (SAE) was an AE resulting in any of the following outcomes or deemed significant for any other reason: death; initial or prolonged inpatient hospitalization; life-threatening experience (immediate risk of dying); persistent or significant disability/incapacity; congenital anomaly. (NCT01069900)
Timeframe: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

,
InterventionSubjects (Number)
Any AEAny SAE
Comparator Ertapenem826
Moxifloxacin (Avelox, BAY12-8039)17520

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Number of Subjects With Musculoskeletal Adverse Events

(NCT01069900)
Timeframe: All AEs and SAE were recorded from treatment start to test of cure visit; musculoskeletal AEs were recorded up to 1 year post-end of treatment (EOT) visit; subjects with musculoskeletal AEs 1 year after EOT were followed up to 5 years or until resolution.

,
InterventionSubjects (Number)
Any AEAny SAE
Comparator Ertapenem50
Moxifloxacin (Avelox, BAY12-8039)131

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Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Calc Bazett Correction on Treatment Day 1 and During Therapy Day 3

"A significant QTc prolongation was considered when the QTc value was more than ULN range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
InterventionPercentage of subjects (Number)
Day1: Pre-dose QTc Calc Bazett > ULN (N= 300, 150)Day1: Post-dose QTc Calc Bazett > ULN (N= 297,148)Day1: Post-dose >30 ms from pre-dose (N= 297,148)Day1: Post-dose >60 ms from pre-dose (N= 297,148)Day3: Pre-dose QTc Calc Bazett > ULN (N= 293, 146)Day3: Post-dose QTc Calc Bazett > ULN (N= 291,148)Day3: Post-dose >30 ms from pre-dose (N= 291,148)Day3: Post-dose >60 ms from pre-dose (N= 291,148)
Comparator Ertapenem2.74.1001.43.420.7
Moxifloxacin (Avelox, BAY12-8039)7.716.25.403.815.59.60.7

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Potentially Clinically Significant Electrocardiogram (ECG) QTc Interval Prolongation - by QTc Interval Calc Fridericia Correction on Treatment Day 1 and During Therapy Day 3

"A significant QTc prolongation was considered when the QTc value was more than (>) upper limit of normal (ULN) range or was prolonged for 30 msec or 60msec in comparison with the pre-treatment value measured on Day 1. N signifies subjects who were evaluable for the specified parameter for each arm, respectively. Percentage of subjects with potentially clinically significant ECG data was reported." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
InterventionPercentage of subjects (Number)
Day1: Pre-dose QTcCalcFridericia>ULN (N= 300, 150)Day1: Post-dose QTcCalcFridericia>ULN (N= 297,148)Day1: Post-dose >30 ms from pre-dose (N= 297,148)Day1: Post-dose >60 ms from pre-dose (N= 297,148)Day3: Pre-dose QTcCalcFridericia>ULN (N= 293, 146)Day3: Post-dose QTcCalcFridericia>ULN (N= 291,148)Day3: Post-dose >30 ms from pre-dose (N= 291,148)Day3: Post-dose >60 ms from pre-dose (N= 291,148)
Comparator Ertapenem1.32001.41.43.40.7
Moxifloxacin (Avelox, BAY12-8039)0.7320.31.49.617.91.7

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PR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

"The PR interval is defined as the period that extends from the onset of atrial depolarization (beginning of the P wave) until the onset of ventricular depolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
Interventionmilliseconds (Mean)
Day 1: Pre-dose (N= 299, 150)Change at Day 1 ( N= 292, 148)Day 3: Pre-dose (N= 293, 146)Change at Day 3 (N= 289, 146)
Comparator Ertapenem140.5933-0.0203139.56851.5616
Moxifloxacin (Avelox, BAY12-8039)136.82940.7123139.49151.5813

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Clinical Response at the End-of-Treatment (EOT) Visit

Clinical responses at EOT were graded as resolution, failure, or indeterminate. 'Resolution' defined as a disappearance of signs and symptoms related to the infection or sufficient improvement of clinical signs and symptoms related to the infection and the subject does not require any further antibiotic therapy or surgical intervention; 'failure' defined as worsening or insufficient lessening of the signs and symptoms of infection requiring a modification or addition of antibacterial therapy; 'indeterminate' is defined as those subjects in whom a clinical assessment is not possible to determine (eg, due to early withdrawal from the study because of adverse events, protocol violation, withdrawn consent; receipt of less than 3 full days of study drug; receipt of an effective concomitant antibacterial for an indication other than study indication; etc). Percentage of subjects with clinical response at EOT were reported. (NCT01069900)
Timeframe: Day 5 to Day 14

,
InterventionPercentage of subjects (Number)
ResolutionClinical FailureIndeterminate
Comparator Ertapenem980.71.4
Moxifloxacin (Avelox, BAY12-8039)92.24.63.2

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QRS Interval Changes in Electrocardiogram (ECG) Profiles From Predose to Post-dose on Treatment Day 1 and Treatment Day 3

"The QRS interval represents the time it takes for ventricular depolarization to occur. N signifies subjects who were evaluable for the specified parameter for each arm, respectively." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
Interventionmilliseconds (Mean)
Day 1: Pre-dose (N= 300, 150)Change at Day 1 (N= 294, 148)Day 3: Pre-dose (N= 293, 146)Change at Day 3 (N= 289, 146)
Comparator Ertapenem88.80671.22389.39040.2877
Moxifloxacin (Avelox, BAY12-8039)89.03330.11989.24230.2768

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QT Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

"The QT interval is the period that extends from the beginning of ventricular depolarization until the end of ventricular repolarization. N signifies subjects who were evaluable for the specified parameter for each arm, respectively." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
Interventionmilliseconds (Mean)
Day 1: Pre-dose (N= 298, 150)Change at Day 1 (N= 290, 148)Day 3: Pre-dose (N= 292, 146)Change at Day 3 (N= 287, 146)
Comparator Ertapenem344.23331.1149356.58223.1644
Moxifloxacin (Avelox, BAY12-8039)341.18122.5828358.30826.0906

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RR Interval Changes in Electrocardiogram (ECG) Profiles From Pre-dose to Post-dose on Treatment Day 1 and Treatment Day 3

"The RR interval refers to the respective time interval in the Electrocardiogram. N signifies subjects who were evaluable for the specified parameter for each arm, respectively." (NCT01069900)
Timeframe: Baseline (Pre-dose), Day 1, Day 3

,
Interventionmilliseconds (Mean)
Day 1: Pre-dose (N= 300, 150)Change at Day 1 (N= 294, 148)Day 3: Pre-dose (N= 293, 146)Change at Day 3 (N= 290, 146)
Comparator Ertapenem689.3067-3.4797754.602710.5137
Moxifloxacin (Avelox, BAY12-8039)670.7567-20.6429740.4778-9.2862

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The Number of Participants With Favorable Per-participant Microbiological Response

Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). (NCT01110382)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)

,
Interventionparticipants (Number)
EIV visitTOC visitLFU visit
Doripenem211717
Meropenem655

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Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit

A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). (NCT01110382)
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)

,
Interventionparticipants (Number)
Streptococcus anginosus (13, 0)Escherichia coli (19, 8)Bacteroides fragilis (11, 1)
Doripenem9159
MeropenemNA51

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Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit

A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated at baseline from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). (NCT01110382)
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)

,
Interventionparticipants (Number)
Streptococcus anginosus (13, 0)Escherichia coli (19, 8)Bacteroides fragilis (11, 1)
Doripenem9159
MeropenemNA51

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The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit

The participants were considered as clinical improved if they had clinical improvement in signs and symptoms of the intra-abdominal infection, no fever, decrease in WBC, and not received any nonstudy antibiotics for the treatment of intra-abdominal infection after IV study drug therapy had begun. (NCT01110382)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)

Interventionparticipants (Number)
Doripenem29
Meropenem8

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The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit

The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit. (NCT01110382)
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)

Interventionparticipants (Number)
Doripenem23
Meropenem7

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The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit

The participants were considered as clinical cure if they had clinical improvement in signs and symptoms of the intra-abdominal infection such that no additional antibacterial therapy or surgical or percutaneous intervention is/was required for the treatment of the index infection, no fever, and a favorable response at End of IV visit. (NCT01110382)
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)

Interventionparticipants (Number)
Doripenem22
Meropenem6

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Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit

A total of 24 pathogens in the doripenem group and 6 pathogens in the meropenem group were isolated at baseline from the intra-abdominal culture and were susceptible to the study drug received. The most common pathogens isolated from the intra-abdominal culture are listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and meropenem treatment groups, respectively. The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). (NCT01110382)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)

,
Interventionparticipants (Number)
Streptococcus anginosus (13, 0)Escherichia coli (19, 8)Bacteroides fragilis (11, 1)
Doripenem121810
MeropenemNA61

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The Number of Participants With Favorable Per-participant Microbiological Response

Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). (NCT01110408)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)

,
InterventionParticipants (Number)
EIV visitTOC visitLFU visit
Cefepime844
Doripenem241916

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The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit

The participants were classified as cure if they had resolution or clinical improvement in signs and symptoms of complicated urinary tract infection; had no fever; no additional antimicrobial therapy was required for the treatment of the infection; and a clinical response assessment of improvement at End of IV visit. (NCT01110408)
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)

InterventionParticipants (Number)
Doripenem20
Cefepime5

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The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit

The participants were considered as clinical improved if they had clinical improvement in signs and symptoms from baseline; no fever for at least the 24 hours before discontinuing the IV study drug; and not received nonstudy antibiotics for the treatment of urinary tract infection after IV study drug therapy had begun. (NCT01110408)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)

InterventionParticipants (Number)
Doripenem28
Cefepime10

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Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit

The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment).A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). (NCT01110408)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)

,
InterventionParticipants (Number)
Staphylococcus aureus (3, 0)Escherichia coli (22, 7)Klebsiella oxytoca (1, 0)Klebsiella pneumoniae (1, 1)
CefepimeNA7NA1
Doripenem32211

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Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit

The favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). (NCT01110408)
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)

,
InterventionParticipants (Number)
Staphylococcus aureus (3, 0)Escherichia coli (22, 7)Klebsiella oxytoca (1, 0)Klebsiella pneumoniae (1, 1)
CefepimeNA4NA0
Doripenem31711

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Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit

The sustained favorable per-pathogen microbiological outcome was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). A total of 4 pathogens in the doripenem group and 2 pathogens in the cefepime group were isolated at baseline from urine culture and were susceptible to the study drug received (see listed in the table below; the numbers in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem and cefepime treatment groups, respectively). (NCT01110408)
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)

,
InterventionParticipants (Number)
Staphylococcus aureus (3, 0)Escherichia coli (22, 7)Klebsiella oxytoca (1, 0)Klebsiella pneumoniae (1, 1)
CefepimeNA4NA0
Doripenem21411

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The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit

The participants were classified as clinical cure if all pretreatment signs and symptoms of complicated urinary tract infection showed no evidence of recurrence after test of cure. (NCT01110408)
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)

InterventionParticipants (Number)
Doripenem18
Cefepime5

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The Number of Participants With Favorable Per-participant Microbiological Response Rate

Favorable per-participant microbiological response rate was evaluated at the at End of IV (EIV) visit, Test Of Cure (TOC) visit, and Late Follow-Up (LFU) visit. The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). (NCT01110421)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy), TOC (7 to 14 days after the last dose of study medication therapy), and LFU (28 to 42 days after the last dose of study medication therapy)

InterventionParticipants (Number)
TOC visitEIV visitLFU visit
Doripenem222

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The Number of Participants With Clinical Cure Rate at Late Follow-Up (LFU) Visit

The participants were classified as clinical cure if all pretreatment signs and symptoms showed no evidence of resurgence after administration of the last dose of study medication and no nonstudy systemic antibacterial therapy was given for the treatment of pneumonia. (NCT01110421)
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)

InterventionParticipants (Number)
Doripenem3
Cefepime2

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The Number of Participants With Clinical Cure Rate at Test Of Cure (TOC) Visit

The participants were classified as cure if they had resolution or clinical improvement of signs and symptoms of pneumonia, favorable response at End of treatment for IV study (EIV) visit; had no fever; improvement or no progression of radiographic findings of pneumonia on chest X ray; improvement in oxygenation or discontinued mechanical ventilation in intubated participants; and not received nonstudy systemic antibacterial therapy for pneumonia. (NCT01110421)
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)

InterventionParticipants (Number)
Doripenem3
Cefepime2

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The Number of Participants With Clinical Improvement Rate at End of IV (EIV) Visit

Participants were considered as clinical improved if they had no fever, clinical improvement in signs and symptoms of pneumonia from baseline, decrease in WBC, improvement or lack of progression of radiographic findings in comparison with the screening chest X-ray, and not received any nonstudy systemic antibacterial therapy for the treatment of pneumonia after IV study drug therapy had begun. (NCT01110421)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)

InterventionParticipants (Number)
Doripenem4
Cefepime2

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Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) Visit

A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis. (NCT01110421)
Timeframe: EIV (within 24 hours after completion of the last dose of IV study medication therapy)

InterventionParticipants (Number)
Staphylococcus aureus (1)Streptococcus pneumoniae (1)Klebsiella pneumoniae (1)
Doripenem111

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Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit

A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis. (NCT01110421)
Timeframe: TOC (7 to 14 days after the last dose of study medication therapy)

InterventionParticipants (Number)
Staphylococcus aureus (1)Streptococcus pneumoniae (1)Klebsiella pneumoniae (1)
Doripenem111

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Number of Participants With Sustained Favorable Per-pathogen Microbiological Outcome Rate at Late Follow-Up (LFU) Visit

A total of 3 pathogens were isolated at baseline from lower respiratory tract (LRT) culture in 2 participants in the doripenem treatment group and were susceptible to the study drug received: 2 pathogens (Staphylococcus aureus Klebsiella pneumoniae) were isolated at baseline from 1 participant and a 3rd pathogen (Streptococcus pneumoniae) was isolated at baseline from the other participant (see listed in the table below; the number in parenthesis next to each pathogen represent the number of participants with the pathogen isolated at baseline in the doripenem treatment group). The favorable per-participant microbiological response was considered when all baseline pathogens were eradicated (absence) or presumed eradicated (absence of material to culture in a participant who has a positive clinical response to treatment). NOTE: No participants in the cefepime treatment group met criteria for inclusion in the Microbiological intent-to-treat analysis. (NCT01110421)
Timeframe: LFU (28 to 42 days after the last dose of study medication therapy)

InterventionParticipants (Number)
Staphylococcus aureus (1)Streptococcus pneumoniae (1)Klebsiella pneumoniae (1)
Doripenem111

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To Evaluate the Rate of Severe Exacerbations in COPD, Comparing COPD Patients Previously Treated According to the PRO-CT Protocol Versus COPD Patients Previously Treated With Standard Antibiotic Therapy.

We prospectively recruited COPD patients hospitalized for severe exacerbation of COPD and followed them after discharge. The primary end point of the study was the number of patients with at least 1 exacerbation at 6 months after the index exacerbation that was the reason for their hospital admission. (NCT01125098)
Timeframe: 6 months

Interventionparticipants (Number)
PRO-CT Group: Experimental28
Standard Group: No Intervention25

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Percentage of Participants With Antibiotic Resistant Flora on Day 30 Compared to Baseline

Percentage of participants with antibiotic resistant flora on day 30 compared to baseline (NCT01166945)
Timeframe: Baseline and 30 days

,
InterventionParticipants (Count of Participants)
Haemophilis Influenza - BaselineHaemophilis Influenza - Day 30Moraxella Catarrhalis - BaselineMoraxella Catarrhalis - Day 30Streptococccus Pneumonia - BaselineStreptococccus Pneumonia - Day 30Streptococcus - BaselineStreptococcus - Day 30Staphylococcus Aureus - BaselineStaphylococcus Aureus - Day 30No Growth - BaselineNo Growth - Day 30Other - BaselineOther - Day 30
Long Course135137832021333632
Short Course13710111186020064229

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Proportion of Children With Clinical Relapse on Day 10 (Short Course) vs Day 20 (Long Course)

Results are based on a daily 6-item symptom survey (day 1 to 14); a daily 3-item survey (day 15 to 30). If a particular symptom is present initially, a score of 2 is given; if it is absent the score is 0. A maximum entry score is 20 (persistent symptoms). If a particular symptom becomes more severe, less severe, or stays the same during treatment, +1, -1, or 0 respectively, will be added to the original score for each symptom. At 10 (and 20 days, respectively), children will be classified as cured, improved or failed based on survey results. Children will be considered cured if they reach a score of < 2. Children will be classified as improved if their score at 10 days (20 days, respectively) is at least 2 points less than their score at 5 days (15 days, respectively). Children will be considered to have failed therapy if their score worsens by + 3 between day 5 (day 15) and day 10 (day 20) or if their score at day 10 (day 20) does not meet criteria for improvement. (NCT01166945)
Timeframe: at 10 days and at 20 days

InterventionParticipants (Count of Participants)
Day 1072336458Day 1072336459Day 2072336458Day 2072336459
CuredFailedImproved
Arm A13
Arm B8
Arm A9
Arm B10
Arm A22
Arm B23
Arm A16
Arm B13
Arm A4
Arm B3
Arm B24

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Gastrointestinal Symptom Rating Scale

Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms (NCT01473368)
Timeframe: Day 0

Interventionunits on a scale (Mean)
Prebiotic (Saccharomyces Boulardii)18.7
Antibiotic (Amoxicillin Clavulanate)18.7
Combination (Prebiotic and Antibiotic)17.3

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Gastrointestinal Symptoms Response Scale

Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms (NCT01473368)
Timeframe: Day 21

Interventionunits on a scale (Mean)
Prebiotic (Saccharomyces Boulardii)19.3
Antibiotic (Amoxicillin Clavulanate)18.4
Combination (Prebiotic and Antibiotic)16.5
Control15.8

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Gastrointestinal Symptoms Response Score

Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms (NCT01473368)
Timeframe: Day 14

Interventionunits on a scale (Mean)
Prebiotic (Saccharomyces Boulardii)19.3
Antibiotic (Amoxicillin Clavulanate)20.3
Combination (Prebiotic and Antibiotic)16.8
Control18.1

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Operational Taxonomic Units

"Core Microbiome includes control samples and baseline samples (Day -7 and Day 0) for antibiotic, probiotic, and combination groups. Data for Core microbiome for individual arms are not available.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21" (NCT01473368)
Timeframe: Day 0 to Day 21

Interventionunits (Mean)
Combination (Prebiotic and Antibiotic) During Treatment449.8
Combination (Prebiotic and Antibiotic) After Treatment509.9
Antibiotic (Amoxicillin Clavulanate) During Treatment461.1
Antibiotic (Amoxicillin Clavulanate) After Treatment668.8
Core Microbiome730.9
Prebiotic (Saccharomyces Boulardii) During Treatment776.7
Prebiotic (Saccharomyces Boulardii) After Treatment776.7

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Prevalence of Escherichia in Stool

"Control arm was not assessed as there was no intervention for this group.~Before Treatment: Average of Day -7 and Day 0 During Treatment: Average of Day 3, Day 7, Day 10, Day 13 After Treatment: Average of Day 21" (NCT01473368)
Timeframe: Day -7 to Day 21

Interventionpercentage of total bacteria (Mean)
Prebiotic (Saccharomyces Boulardii) Before Treatment0.0
Prebiotic (Saccharomyces Boulardii) During Treatment0.0
Prebiotic (Saccharomyces Boulardii) After Treatment0.1
Antibiotic (Amoxicillin Clavulanate) Before Treatment0.1
Antibiotic (Amoxicillin Clavulanate) During Treatment4.5
Antibiotic (Amoxicillin Clavulanate) After Treatment0.2
Combination (Prebiotic and Antibiotic) Before Treatment0.0
Combination (Prebiotic and Antibiotic) During Treatment2.9
Combination (Prebiotic and Antibiotic) After Treatment0.2

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Gastrointestinal Symptom Rating Scale

Mean Gastrointestinal Symptom Rating Scale scores Range from 15 to 90 Increasing score means increasing symptoms (NCT01473368)
Timeframe: Day 7

InterventionUnits on a scale (Mean)
Prebiotic (Saccharomyces Boulardii)23.2
Antibiotic (Amoxicillin Clavulanate)26.9
Combination (Prebiotic and Antibiotic)18.1
Control19.3

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The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The day 12-14 visit. The mean day for this visit was 13.9.

,
Interventionrecurrence (Number)
+ for nonsusceptible pathogen(s) day 12-14pathogen - or + only for susceptible day 12-14
Amoxicillin-Clavulanate, 10 Days836
Amoxicillin-Clavulanate, 5 Days627

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The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment

"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses within 60 days of enrollment by the number of months of follow-up within 60 days of enrollment." (NCT01511107)
Timeframe: Day 1 of study entry until day 60.

Interventionrecurrences/relapses per month (Mean)
Amoxicillin-Clavulanate, 10 Days0.15
Amoxicillin-Clavulanate, 5 Days0.12

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The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The end-of-treatment visit. The mean day for this visit was 13.4.

,
Interventionrecurrence (Number)
+ for nonsusceptible pathogen(s) day 12-14pathogen - or + only for susceptible day 12-14
Amoxicillin-Clavulanate, 10 Days1716
Amoxicillin-Clavulanate, 5 Days227

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The Distribution of AOM Recurrences With a Nasopharyngeal (NP) Culture at Onset That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The day 12-14 visit. The mean day for this visit was 13.4.

,
Interventionrecurrence (Number)
+ for nonsusceptible pathogen(s) day 12-14pathogen - or + only for susceptible day 12-14
Amoxicillin-Clavulanate, 10 Days1234
Amoxicillin-Clavulanate, 5 Days824

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The Distribution of Children Whose Nasopharyngeal (NP) Isolates at Enrollment Are Pathogen Negative or Positive Only for at Least One Susceptible Pathogen Who Become Colonized With Nonsusceptible Pathogens at Any Time Over the Course of Follow-up

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: Day 1 of study entry until day 365

,
Interventionparticipants (Number)
+ for a nonsusceptible pathogen during followup- for a nonsusceptible pathogen during followup
Amoxicillin-Clavulanate, 10 Days8596
Amoxicillin-Clavulanate, 5 Days7899

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The Distribution of Children for Whom Diaper Dermatitis Was Reported and Associated With Study Product

Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product. (NCT01511107)
Timeframe: Day 1 of administration of study product until day 16 for all episodes

,
Interventionparticipants (Number)
Diaper dermatitis reportedDiaper dermatitis not reported
Amoxicillin-Clavulanate, 10 Days85172
Amoxicillin-Clavulanate, 5 Days87171

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The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate

In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. (NCT01511107)
Timeframe: The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.

,
Interventionparticipants (Number)
S pn, nonsusceptibleS pn, susceptibleS pn, absent
Amoxicillin-Clavulanate, 10 Days235205
Amoxicillin-Clavulanate, 5 Days2610186

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The Distribution of Children for Whom the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit, Specific to the Index Episode, Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate

In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The day 12-14 visit specific to the index episode. The mean day for this visit was 13.4.

,
Interventionparticipants (Number)
H flu, nonsusceptibleH flu, susceptibleH flu, absent
Amoxicillin-Clavulanate, 10 Days3839156
Amoxicillin-Clavulanate, 5 Days2837157

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The Distribution of Children for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product

Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product. (NCT01511107)
Timeframe: Day 1 of administration of study product until day 16 for all episodes

,
Interventionparticipants (Number)
PDD reportedPDD not reported
Amoxicillin-Clavulanate, 10 Days78179
Amoxicillin-Clavulanate, 5 Days75183

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The Distribution of AOM Recurrences Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit

"Proportion of AOM recurrences resulting in treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of the recurrence, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable." (NCT01511107)
Timeframe: From 72 hours after the AOM recurrence was diagnosed until day 21 of the recurrence. The mean day for this visit was 13.3.

,
Interventionrecurrence (Number)
Treatment failureTreatment success
Amoxicillin-Clavulanate, 10 Days25108
Amoxicillin-Clavulanate, 5 Days2973

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The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive for One or More Nonsusceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The end-of-treatment visit. The mean day for this visit was 13.6.

,
Interventionparticipants (Number)
+ for nonsusceptible pathogen(s) day 12-14pathogen - or + only for susceptible day 12-14
Amoxicillin-Clavulanate, 10 Days3430
Amoxicillin-Clavulanate, 5 Days2832

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The Distribution of Children Categorized as Treatment Failure (TF) at or Before the Day 12-14 End-of-Treatment Visit Specific to the Index Episode of AOM

"Proportion of children initially diagnosed with AOM who experience treatment failure at or before the day 12-14 visit.~TF is defined as substantial persistence or worsening of symptoms specifically attributable to AOM, or of otoscopic signs of AOM, after 72 hours from the time of randomization, such that additional antimicrobial therapy is deemed advisable. If a parent/legal guardian is unwilling to continue the assigned study product regimen, the participant will be categorized as TF. Should a participant be administered another systemic antibiotic while taking study medication or prior to Day 16, the participant will be considered a TF. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the tympanic membrane (TM) or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable." (NCT01511107)
Timeframe: From 72 hours after randomization until day 21 of the index episode. The mean day for this visit was 13.2.

,
Interventionparticipants (Number)
Treatment failureTreatment success
Amoxicillin-Clavulanate, 10 Days39199
Amoxicillin-Clavulanate, 5 Days77152

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The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Positive Only for One or More Susceptible Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The day 12-14 visit. The mean day for this visit was 13.2.

,
Interventionparticipants (Number)
+ for nonsusceptible pathogen(s) day 12-14pathogen - or + only for susceptible day 12-14
Amoxicillin-Clavulanate, 10 Days1083
Amoxicillin-Clavulanate, 5 Days1278

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The Distribution of Children With AOM Recurrences and Relapses Within 60 Days of Enrollment

An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences. (NCT01511107)
Timeframe: Day 1 of study entry until day 60.

,
Interventionparticipants (Number)
# cumulative recurrences/relapses = 0# cumulative recurrences/relapses = 1# cumulative recurrences/relapses = 2
Amoxicillin-Clavulanate, 10 Days173662
Amoxicillin-Clavulanate, 5 Days173483

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The Distribution of Children With AOM Recurrences and Relapses Within the Entire Respiratory Season

An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences. (NCT01511107)
Timeframe: Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.

,
Interventionparticipants (Number)
# cumulative recurrences/relapses = 0# cumulative recurrences/relapses = 1# cumulative recurrences/relapses = 2# cumulative recurrences/relapses = 3# cumulative recurrences/relapses = 4
Amoxicillin-Clavulanate, 10 Days135613183
Amoxicillin-Clavulanate, 5 Days133592043

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The Mean Acute Otitis Media - Severity of Symptom (AOM-SOS) Scores Days 6 to 14

"The AOM-SOS scale measures seven discrete items: tugging of ears, crying, irritability, difficulty sleeping, diminished activity, diminished appetite, and fever. The parent rated each of these symptoms in comparison with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2, and recorded the ratings in a diary. Each set of ratings was summed to obtain an AOM-SOS score as a measure of symptom burden. Total scores range from 0 to 14, with higher scores indicating greater severity of symptoms. For instances in which the participant was declared a treatment failure, scores are included up to, but not including the day of the failure. Otherwise, scores day 6 to day 14 are included." (NCT01511107)
Timeframe: From day 6 of administration of study product until day 14 for all episodes

,
InterventionAOM-SOS score (Mean)
Day 6Day 7Day 8Day 9Day 10Day 11Day 12Day 13Day 14
Amoxicillin-Clavulanate, 10 Days1.721.461.291.291.121.021.071.151.16
Amoxicillin-Clavulanate, 5 Days1.641.571.561.411.431.401.251.401.37

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The Mean Number of Days Systemic Antibiotics Were Received During the Entire Respiratory Season

Systemic antibiotics include the study product, Amoxicillin-Clavulanate, dispensed for either 10 or 5 days and various concomitant medications, i.e. Amoxicillin, Amox/Clav, Azithromycin, Cefdinir, Cefpodoxime, Ceftriaxone, Erythromycin, Trimethoprim-Sulfamethoxazole, Omnicef, Augmentin, Azithromycin, Cefazolin, Clarythromycin and Ciprofloxacin. (NCT01511107)
Timeframe: Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.

,
Interventiondays (Mean)
Study productOther systemic antibioticAll systemic antibiotics
Amoxicillin-Clavulanate, 10 Days14.726.1920.91
Amoxicillin-Clavulanate, 5 Days6.797.9814.77

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The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Streptococcus Pneumoniae (S pn) Isolate

In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. (NCT01511107)
Timeframe: The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.

,
Interventionrecurrence (Number)
S pn, nonsusceptibleS pn, susceptibleS pn, absent
Amoxicillin-Clavulanate, 10 Days204107
Amoxicillin-Clavulanate, 5 Days25668

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The Distribution of AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate

In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The day 12-14 visit following a recurrence. The mean day for this visit was 13.6.

,
Interventionrecurrence (Number)
H flu, nonsusceptibleH flu, susceptibleH flu, absent
Amoxicillin-Clavulanate, 10 Days191795
Amoxicillin-Clavulanate, 5 Days152064

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The Distribution of 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.

,
InterventionVisit (Number)
+ for nonsusceptible pathogen(s)pathogen - or + only for susceptible pathogen(s)
Amoxicillin-Clavulanate, 10 Days79336
Amoxicillin-Clavulanate, 5 Days64295

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The Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within the Entire Respiratory Season

"An episode of AOM occurring after Day 16 will be considered a recurrence. Subjects seen after day 10 and categorized as clinical success who return for an interim/sick visit before day 17 and are found to have AOM will be categorized as a relapse. For secondary outcome analyses, relapses are combined with recurrences.~The rate, expressed as a monthly rate, is calculated by dividing the total number of recurrences and relapses by the number of months of follow-up." (NCT01511107)
Timeframe: Day 1 of study entry until day 244. The respiratory season is October 1 - May 31, inclusive.

Interventionrecurrences/relapses per months followed (Mean)
Amoxicillin-Clavulanate, 10 Days0.14
Amoxicillin-Clavulanate, 5 Days0.12

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The Distribution of Children With a Nasopharyngeal (NP) Culture at Enrollment That is Negative for AOM Pathogens in Which the Follow-up NP Culture at Day 12-14 Yields a Nonsusceptible Pathogen

AOM pathogens are defined as Streptococcus pneumoniae (S pn) or Haemophilus Influenzae (H flu). In the case of S pn, susceptibility to penicillin was determined as follows: When minimum inhibitory concentration (MIC) was available, susceptible was defined as MIC <0.1 µg/mL, intermediate as MIC 0.1 to 1 µg/mL, and resistant as MIC >1 µg/mL. When MIC was not available, susceptible was defined as showing oxacillin disk zone size >20 mm, intermediate as zone size 9 to 20 mm, and resistant as zone size ≤8 mm. In the case of H flu, susceptible was defined as beta-lactamase-negative and ampicillin E test MIC ≤1 µg/mL; nonsusceptible was defined as either beta-lactamase-positive or beta-lactamase-negative and ampicillin E test MIC >1 µg/mL. (NCT01511107)
Timeframe: The day 12-14 visit. The mean day for this visit was 13.3.

,
Interventionparticipants (Number)
+ for nonsusceptible pathogen(s) day 12-14pathogen - or + only for susceptible day 12-14
Amoxicillin-Clavulanate, 10 Days1560
Amoxicillin-Clavulanate, 5 Days1161

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Healthcare Utilization

Questionnaire designed to evaluate healthcare utilization following surgery. Unit of measure will be the number of participants utilizing each category of healthcare. (NCT01561703)
Timeframe: 6 wks post-operative appointment

,
Interventionparticipants (Number)
Reported FeverMade a phone call to clinicER/UR/Clinic visit"Received additional antibiotic"Diagnostic workup at ER
Control168966
Intervention55200

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Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)

A negative post-treatment 13C-urea breath test or CLO test result at more than 4 weeks after complete use of drug for treatment. (NCT01575899)
Timeframe: 4 weeks after complete use of drug for treatment

Interventionpercentage of eradicated participants (Number)
Levofloxacin-Amox/Clav.78.1
Clarithromycin-Amoxicillin57.5

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Eradication Rate of Participants Living in Rural Area.

Subgroup analysis on eradication rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after treatment) according to resident area of participants, especially who are living in rural area. (NCT01575899)
Timeframe: 4 weeks after complete use of drug for treatment

Interventionpercentage of eradicated participants (Number)
Levofloxacin-Amox/Clav.81.4
Clarithromycin-Amoxicillin51.3

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Re-eradication Rate

Re-eradication successful rate (percentage of participants with a negative result of C13 or CLO test at least four weeks after the 2nd treatment) with 7-day levofloxacin, amoxicillin/clavulanate and rabeprazole for patients still with Hp infection previously treated with regimen without levofloxacin and Augmentin. (NCT01575899)
Timeframe: 4 weeks after complete use of drug for treatment

Interventionpercentage of successful re-eradication (Number)
Levofloxacin-Amox/Clav. (Re-eradication)72.6

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Lund Kennedy Endoscopic Score

"The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).~Scores range from 0 to 20 with higher scores indicating greater sinus disease." (NCT01919411)
Timeframe: Six weeks postoperatively

Interventionscore on a scale (Mean)
Amoxicillin-Potassium Clavulanate4.3
Placebo4.5

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Number of Participants With Post Operative Infection

The investigators will record the rate of post operative infections in the two groups. (NCT01919411)
Timeframe: One week postoperatively

InterventionParticipants (Count of Participants)
Amoxicillin-Potassium Clavulanate1
Placebo0

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Number of Participants With Post Operative Infection

The investigators will record the rate of post operative infections in the two groups. (NCT01919411)
Timeframe: Six weeks postoperatively

InterventionParticipants (Count of Participants)
Amoxicillin-Potassium Clavulanate0
Placebo0

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Sinonasal Outcome Test - 22

"The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.~Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms." (NCT01919411)
Timeframe: One week post operatively

Interventionscore on a scale (Mean)
Amoxicillin-Potassium Clavulanate31.3
Placebo31.0

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Lund Kennedy Endoscopic Score

"The Lund Kennedy endoscopic score is a grading system for visually evaluating patient's sinus cavities before and after surgery. It has five measures to score (polyps, edema, discharge, scarring, and crusting).~Scores range from 0 to 20 with higher scores indicating greater sinus disease." (NCT01919411)
Timeframe: One week postoperatively

Interventionscore on a scale (Mean)
Amoxicillin-Potassium Clavulanate5.6
Placebo5.9

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Sinonasal Outcome Test - 22

"The sinonasal outcome test -22 (SNOT-22) is a validated instrument for measuring quality of life outcomes in chronic sinusitis.~Snot-22 scores can range from 0 to 110. Higher scores indicate more severe symptoms." (NCT01919411)
Timeframe: Six weeks post operatively

Interventionscore on a scale (Mean)
Amoxicillin-Potassium Clavulanate22.3
Placebo17.5

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"Number of Participants With a Clinical Outcome of Cure at Both the End of Treatment and Test of Cure (EOT and TOC: Day 8 and Day 15)"

"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) and TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation. In order to be categorized as cure, participants had to meet the criteria for cure at both Day 8 and Day 15." (NCT01934231)
Timeframe: Day 8 and Day 15

InterventionParticipants (Number)
CureFailureUnable to Determine
CVA/AMPC (1:14)2330

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"Number of Participants With a Clinical Outcome of Cure at Test of Cure (TOC: Day 15)"

"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at TOC (Day 15) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation." (NCT01934231)
Timeframe: Day 15

InterventionParticipants (Number)
CureFailureUnable to Determine
CVA/AMPC (1:14)2330

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"Number of Participants With a Clinical Outcome of Cure at the End of Treatment (EOT: Day 8)"

"Clinical assessment of acute bacterial rhinosinusitis was performed by the investigator (or subinvestigator) at the EOT (Day 8) on the basis of the following criteria: Cure is defined as sufficient resolution or improvement of the signs and symptoms such that no additional antibiotic therapy is needed. Failure is defined as no change or deterioration of the signs and symptoms or as additional antibiotic therapy being needed. The outcome was unable to be determined if no information was available regarding the signs and symptoms or, despite improvement of the signs and symptoms, the use of a non-study antibiotic was administered, indicating that there was a protocol deviation." (NCT01934231)
Timeframe: Day 8

InterventionParticipants (Number)
CureFailureUnable to Determine
CVA/AMPC (1:14)2510

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Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Participant at EOT (Day 8)

The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each par. using the following classification: Bact. eradication (erad.), presumed bact. erad. and colonization were categorized as erad. Bact. persistence (pers.), presumed bact. pers. and superinfection were categorized as pers. Bact. erad. elimination of the pathogen (path.) after trt; presumed bact. erad.-resolution of signs/symptoms (s/s) after trt; colonization-resolution of s/s but initial path. still recovered from sample; bact. pers.-no improvement in s/s and initial path. was recovered from sample; presumed bact. pers.-no improvement in s/s and isolation of initial path. was impossible/not performed; superinfection-initial path. was eradicated but a new path. was recovered; unable to determine-bact. test could not be performed. (NCT01934231)
Timeframe: Day 8

InterventionParticipants (Number)
EradicationPersistence
CVA/AMPC (1:14)240

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Number of Participants (Par.) With the Specified Bacteriological (Bact.) Outcome Per Pathogen (Path.) at the End of Treatment (EOT) at Day 8

"The investigator used the sample collected at the start of study treatment (trt) to isolate and identify the pathogenic bacteria. The sample collected at the EOT was used to evaluate the bact. response to the investigational product of each path. If the same pathogen was not detected at the EOT, this pathogen was classified as eradication (E). If the same pathogen was detected at the EOT, this pathogen was classified as persistence (P)." (NCT01934231)
Timeframe: Day 8

InterventionParticipants (Number)
Streptococcus pneumoniae (StPn), EStPn, PPenicillin Susceptible (PenSusc) StPn, EPenSuscStPn, PPen Intermediate (PenInt) StPn, EPenIntStPn, PPen Resistant (PenR) StPn, EPenRStPn, PMoraxella (Branhamella) catarrhalis (MBC), EMBC, PMBC beta-lactamase (BL) positive, EMBC BL positive, PMBC BL negative (N), EMBC BLN, PHaemophilus influenzae (HI), EHI, PHI BLN ampicillin (A) susceptible (S), EHI BLNAS, PHI BLNA resistant (R), EHI BLNAR, PHI BL Producing (Pr) AR, EHI BLPrAR, PStaphylococcus aureus (Staph Ar), EStaph Ar, PMethicillin R Staph Ar, EMethicillin R Staph Ar, PStreptococcus pyogenes, EStreptococcus pyogenes, PEnterobacter species (sp), EEnterobacter sp., PCoagulase (Coag) NStaph, ECoagNStaph, PCorynebacterium sp., ECorynebacterium sp., PStreptococcus sp., EStreptococcus sp., PPseudomonas aeruginosa, EPseudomonas aeruginosa, P
CVA/AMPC (1:14)81711000606000868203015000101030101000

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Number of Participants With the Indicated Severity of Symptoms and Nasal Cavity Findings at Day 4, Day 8, and Day 15

The investigator (or sub-investigator) categorized the severity of symptoms such as rhinorrhoea and bad mood/productive cough as none, mild/small amount (M/SA), or moderate or severe (M or S). For the nasal cavity finding of nasal/postnasal discharge (N/PD) the categozation was serous [containing serum]), mucopurulent (MU/SA [containing both mucus and pus]), and moderate or larger amount (M/LA). In cases in which both sides of the nasal cavity were affected and there was no difference in severity between the sides, the right-side results were recorded. If there was a difference in severity, the more severe-side results were recorded. (NCT01934231)
Timeframe: Baseline (BL), Day 4, Day 8, and Day 15

InterventionParticipants (Number)
Rhinorrhoea: BL, NoneRhinorrhoea: BL, M/SARhinorrhoea: BL, M or SRhinorrhoea: Day 4, NoneRhinorrhoea: Day 4, M/SARhinorrhoea: Day 4, M or SRhinorrhoea: Day 8, NoneRhinorrhoea: Day 8, M/SARhinorrhoea: Day 8, M or SRhinorrhoea: Day 15, NoneRhinorrhoea: Day 15, M/SARhinorrhoea: Day 15, M or SBad mood/productive cough: BL NoneBad mood/productive cough: BL, M/SABad mood/productive cough: BL, M or SBad mood/productive cough: Day 4, NoneBad mood/productive cough: Day 4, M/SABad mood/productive cough: Day 4, M or SBad mood/productive cough: Day 8, NoneBad mood/productive cough: Day 8, M/SABad mood/productive cough: Day 8, M or SBad mood/productive cough: Day 15, NoneBad mood/productive cough: Day 15, M/SABad mood/productive cough: Day 15, M or SN/PD: BL, SerousN/PD: BL, MU/SAN/PD: BL, M/LAN/PD: Day 4, SerousN/PD: Day 4, MU/SAN/PD: Day 4, M/LAN/PD: Day 8, SerousN/PD: Day 8, MU/SAN/PD: Day 8, M/LAN/PD: Day 15, SerousN/PD: Day 15, MU/SAN/PD: Day 15, M/LA
CVA/AMPC (1:14)052171631313018804202161002150242006201410222402150

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Number of Participants (Par.) Achieving Clinical Success (CS) (Cure or Improvement [Imp] in Signs [s] and Symptoms [sx] [s/sx]) Without Considering Clinical (cl) Judgment (Jdg) of the Investigator (Inv) at Day 5

CS is defined as cure or imp in s/sx of odontogenic infections. Cure is defined as the complete resolution of s/sx of infection present at Baseline (BL) and imp is defined as resolution of fever (if present at BL), >70% reduction in swelling and pain and imp in other s/sx such that no additional antimicrobial (ant) therapy is required. In event of cure or imp with complete resolution of fever and >70% reduction in swelling and pain, but 'no change' or 'worsening from BL' in other s/sx (like increased leucocyte count/tooth mobility), the inv's opinion was sought on whether additional ant therapy was required. Par. that required no additional ant therapy were considered a 'success' while those requiring additional ant therapy were deemed a 'failure'. For a sensitivity analysis, all such par. with 'no change' or 'worsening from BL' in these other s/sx were considered as cl failures and termed 'Without Considering Cl Jdg of Inv', even though main s/sx are 'cured' or 'improved'. . (NCT02141217)
Timeframe: Day 5

InterventionParticipants (Number)
Amoxicillin 875 mg + Clavulanic Acid 125 mg158
Clindamycin 150 mg150

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Number of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at Day 5

Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. (NCT02141217)
Timeframe: Day 5

InterventionParticipants (Number)
Amoxicillin 875 mg + Clavulanic Acid 125 mg169
Clindamycin 150 mg159

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Percentage of Participants Achieving Clinical Success (Cure or Improvement) Considering Clinical Judgment of the Investigator at the End of Treatment (Day 5 or Day 7)

Clinical success is defined as the achievement of cure or improvement in signs and symptoms of odontogenic infections. Cure is defined as the complete resolution of signs and symptoms of infection present at baseline, such that no additional antimicrobial therapy is required. Improvement is defined as the resolution of fever (if present at baseline), >70% reduction in swelling and pain and improvement in other signs and symptoms such that no additional antimicrobial therapy is required. Visual Analogue Scale (VAS) is used to measure the amount of pain and swelling that a participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. (NCT02141217)
Timeframe: Day 5 or Day 7 [End of treatment]

InterventionPercentage of participants (Number)
Amoxicillin 875 mg + Clavulanic Acid 125 mg88.2
Clindamycin 150 mg89.7
Amoxicillin 875 mg + Clavulanic Acid 125 mg85.5
Clindamycin 150 mg86.4
Amoxicillin 875 mg + Clavulanic Acid 125 mg83.3
Clindamycin 150 mg85.7

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Change From Baseline in the Visual Analogue Scale Assessment of Pain Score at Days 2, 5 and 7

Visual Analogue Scale (VAS) is used to measure the amount of pain that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no pain and 10 indicates worst possible pain. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7). (NCT02141217)
Timeframe: Baseline, Days 2, 5 and 7

,
InterventionScores on a scale (Least Squares Mean)
Day 2, n=227, 233Day 5, n=219, 228Day 7, n=57, 71
Amoxicillin 875 mg + Clavulanic Acid 125 mg3.345.496.38
Clindamycin 150 mg3.075.386.34

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Change From Baseline in Visual Analogue Scale Assessment of Swelling at Days 2, 5 and 7

Visual Analogue Scale (VAS) is used to measure the amount of swelling that the participant experiences. This scale has numerical ratings from 0 to 10. Zero indicates no swelling and 10 indicates worst possible swelling. Change in Pain/Swelling is calculated as VAS score at Baseline minus the score at a later time point (Day 2, 5 or 7). (NCT02141217)
Timeframe: Baseline, Days 2, 5 and 7

,
InterventionScores on a scale (Least Squares Mean)
Day 2, n=219, 225Day 5, n=214, 223Day 7, n=55, 68
Amoxicillin 875 mg + Clavulanic Acid 125 mg1.923.684.21
Clindamycin 150 mg1.613.604.61

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Efficacy of Timentin Delivered by PILP Procedure (Treatment Group) Versus Intravenous Delivery (Control Group) at Reducing Microbiological Load in Subjects With Diabetes, and Significant Wound Infection of the Lower Limb.

Reduction in microbiological load, including assessment of CFU, infection type and antibiotic sensitivity between the two groups over time. To compare the efficacy of Timentin delivered by PILP procedure (Treatment Group) versus intravenous delivery (Control Group) at reducing microbiological load in subjects with diabetes, and significant wound infection of the lower limb. (NCT02158442)
Timeframe: Day 3

Interventionparticipants (Number)
Treatment Group5
Control Group3

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Willingness to Take the Study Antibiotic in the Future

whether participants said they would NOT take the antibiotic again (NCT02340000)
Timeframe: end of 10th day

InterventionParticipants (Count of Participants)
Standard Dose Time Period I8
High Dose Time Period 111
Standard Dose Time Period 25
High Dose Time Period 28

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Nasal Colonization With Resistant Bacteria

Clinicians performed anterior nasal cultures to look for colonization with penicillin-resistant pneumococci and other pathogens (stopped after participant #231 because of lack of funds). (NCT02340000)
Timeframe: baseline

InterventionParticipants (Count of Participants)
No growth or normal floraMethicillin-sensitive Staphylococcus aureusHaemophilus influenzaeStreptococcus pneumoniaeMoxarella catarrhalisStaphylococcus epidermidisMethicillin-resistant Staphylococcus aureus
Overall13932259975

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SNOT-16 - Day 10

"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.~The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 10 (values at day 0 minus values at day 10)." (NCT02340000)
Timeframe: day 0, end of 10th day

Interventionunits on a scale (Mean)
Standard Dose Time Period I1.32
High Dose Time Period 11.48
Standard Dose Time Period 21.37
High Dose Time Period 21.40

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SNOT-16 - Day 3

"Ratings on a scale from 0=none to 3=severe of 16 sinusitis-related symptoms. Total score can range from 0 to 48 (with 48 the most severe possible) of the 16 symptoms.~The outcome measure was the mean difference in the ratings of each of the 16 symptoms between day 0 and day 3 (values at day 0 minus values at day 3)." (NCT02340000)
Timeframe: day 0, end of 3 days of treatment

Interventionunits on a scale (Mean)
Standard Dose Time Period I.75
High Dose Time Period 1.87
Standard Dose Time Period 2.91
High Dose Time Period 2.97

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Subjective Improvement - Day 10

"rating of a lot better or no symptoms" (NCT02340000)
Timeframe: end of 10th day

InterventionParticipants (Count of Participants)
Standard Dose Time Period I63
High Dose Time Period 159
Standard Dose Time Period 235
High Dose Time Period 240

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"Subjective Improvement - Day 3 (Rating of a Lot Better or no Symptoms)"

"rating of a lot better or no symptoms" (NCT02340000)
Timeframe: end of 3 days of treatment

InterventionParticipants (Count of Participants)
Standard Dose Time Period I33
High Dose Time Period 131
Standard Dose Time Period 222
High Dose Time Period 233

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The Distribution of Children Experiencing Treatment Failure (TF)

The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough & trouble sleeping - as none, almost none, a little, some, a lot & an extreme amount with respective scores of 0, 1, 2, 3, 4 & 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment), electronically evenings Days 2-11 & at the follow-up visit. If, compared to the Day 1 score, there was >20% increase at any time, decrease <2 on Day 3, <20% decrease on Day 4, <20% decrease on 2 consecutive occasions Days 5-11 or <50% decrease at follow-up, then criterion for treatment failure (TF) was met. Multiple imputation was used when data was insufficient to assess TF. (NCT02554383)
Timeframe: Day of enrollment to the day of the follow-up visit. The mean length of actual follow-up was 13.4 days. For each child with incomplete follow-up, multiple imputation was used and PRSS scores for the remaining days were imputed.

,
InterventionParticipants (Count of Participants)
Experienced failureDid not experience failure
Amoxicillin-clavulanate76178
Placebo111145

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The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Pathogens in the Nasopharynx at Enrollment

The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough & trouble sleeping - as none, almost none, a little, some, a lot & an extreme amount with respective scores of 0, 1, 2, 3, 4 & 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) & electronically on diaries evenings Days 2-11. Pathogens cultured were Streptococcus pneumoniae, Haemophilus influenzae, and Moraxella catarrhalis. (NCT02554383)
Timeframe: Days 2 to 11

,
InterventionScore on a scale (Mean)
Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 2Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 3Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 4Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 5Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 6Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 7Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 8Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 9Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 10Presence of 1 or more pathogens in the nasopharynx at enrollment - Day 11Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 2Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 3Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 4Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 5Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 6Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 7Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 8Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 9Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 10Absence of 1 or more pathogens in the nasopharynx at enrollment - Day 11
Amoxicillin-clavulanate17.313.911.810.18.57.36.44.94.23.719.515.511.910.38.16.96.25.44.94.1
Placebo18.616.613.912.010.98.98.37.46.05.818.715.512.510.59.48.37.46.35.54.1

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The Distribution of Children Compliant With Study Medication

Compliance, expressed as a percentage, is the total number of doses taken divided by the total number of expected doses. The child is considered compliant if he/she has received at least 70% of the study medication. The parent completed diaries evenings Days 2-11. The diaries included yes/no questions - (1) did your child take the study medication last night and (2) did your child take the study medication this morning? The total number of doses taken was calculated based on the responses to question (1), and accounted for the dose dispensed at enrollment when enrollment was 1pm or earlier on Day 1. The total of expected doses was determined from the responses to questions (1) and (2), and accounted for scenarios in which the child was taken off the study medication by the clinician. In some cases, due to incomplete diaries the information was insufficient to declare a child either compliant or not compliant. (NCT02554383)
Timeframe: Days 1 to 11, where Day 1 is day of enrollment

,
InterventionParticipants (Count of Participants)
Compliant, i.e., received at least 70% of the the study medicationNot compliant, i.e., received less than 70% of study medication
Amoxicillin-clavulanate21214
Placebo22113

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The Mean Pediatric Rhinosinusitis Symptom Scale (PRSS) Score Over the First 10 Days of Follow-up According to the Presence of Colored Nasal Discharge at Enrollment

The Pediatric Rhinosinusitis Symptom Scale (PRSS) is a 8 item scale assessing symptoms of sinusitis. Parents are asked how their child has been doing over the last 24 hours by rating each of 8 symptoms - stuffy nose, runny nose, daytime cough, tiredness, irritability, trouble breathing through the nose, nighttime cough & trouble sleeping - as none, almost none, a little, some, a lot & an extreme amount with respective scores of 0, 1, 2, 3, 4 & 5. The 8 ratings were summed to obtain a PRSS score. Scores ranged from 0-40. Higher scores indicate greater severity. The parent completed the scale on Day 1 (enrollment) & electronically on diaries evenings Days 2-11. Nasal discharge, either yellow or green, was considered colored. (NCT02554383)
Timeframe: Days 2 to 11

,
InterventionScore on a scale (Mean)
Presence of colored nasal discharge at enrollment - Day 2Presence of colored nasal discharge at enrollment - Day 3Presence of colored nasal discharge at enrollment - Day 4Presence of colored nasal discharge at enrollment - Day 5Presence of colored nasal discharge at enrollment - Day 6Presence of colored nasal discharge at enrollment - Day 7Presence of colored nasal discharge at enrollment - Day 8Presence of colored nasal discharge at enrollment - Day 9Presence of colored nasal discharge at enrollment - Day 10Presence of colored nasal discharge at enrollment - Day 11Absence of colored nasal discharge at enrollment - Day 2Absence of colored nasal discharge at enrollment - Day 3Absence of colored nasal discharge at enrollment - Day 4Absence of colored nasal discharge at enrollment - Day 5Absence of colored nasal discharge at enrollment - Day 6Absence of colored nasal discharge at enrollment - Day 7Absence of colored nasal discharge at enrollment - Day 8Absence of colored nasal discharge at enrollment - Day 9Absence of colored nasal discharge at enrollment - Day 10Absence of colored nasal discharge at enrollment - Day 11
Amoxicillin-clavulanate18.614.812.110.88.67.46.45.14.43.716.413.311.19.07.86.76.14.94.54.0
Placebo19.016.613.711.310.58.88.27.05.75.217.615.612.912.110.58.87.77.36.25.7

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The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit

The nonsusceptible pathogens considered are penicillin-intermediate and penicillin-resistant Streptococcus pneumoniae (SPN) and ß-lactamase-positive Haemophilus influenzae (NTHi). Susceptibility to penicillin was defined as follows: susceptible as a minimum inhibitory concentration (MIC) of <=0.06 μg/mL; intermediate as an MIC of greater than 0.06 to less than 2 μg/mL; and resistant as an MIC of >=2 μg/mL. A nasopharyngeal specimen for bacterial culture was obtained at the time of the follow-up visit, occurring between study days 11 and 23. (NCT02554383)
Timeframe: The follow-up visit. The mean number of days from enrollment to the follow-up visit was 13.4.

,
InterventionParticipants (Count of Participants)
Nonsusceptible pathogen at the follow-up visitNo nonsusceptible pathogen at the follow-up visit
Amoxicillin-clavulanate19129
Placebo18134

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The Distribution of Children Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up

Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin & Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded. The antibiotic received is exclusive of the study product assigned at enrollment. (NCT02554383)
Timeframe: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.

,
InterventionParticipants (Count of Participants)
Received a systemic antibioticDid not receive a systemic antibiotic
Amoxicillin-clavulanate34217
Placebo66190

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The Distribution of Children for Whom Diarrhea or Generalized Rash Was Reported

The monitoring of adverse events (AEs), i.e. diarrhea or generalized rash, began on Day 1 (enrollment) and continued through Day 23 (the follow-up visit). Diarrhea was the occurrence of 3 or more watery stools on one day or 2 watery stools on each of 2 consecutive days. Parents recorded in daily diaries, Days 1-11, information regarding the occurrence of diarrhea. Additionally, parents were asked at the follow-up visit if their child had diarrhea while on study product. (NCT02554383)
Timeframe: Day 1 through Day 23.

,
InterventionParticipants (Count of Participants)
Diarrhea or rash was reportedNeither diarrhea nor rash was reported
Amoxicillin-clavulanate31223
Placebo13243

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The Distribution of Children Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up

AOM is an infection of the middle ear marked by acute symptoms and a bulging tympanic membrane. Its diagnosis coincided with receipt of a systemic antibiotic. Systemic antibiotics include Amoxicillin, Amoxicillin-clavulanate, Azithromycin, Bacillin L-A, Cefdinir, Clindamycin, Doxycycline, Levofloxacin, Ofloxacin & Sulfamethoxazole-Trimethoprim. Start and stop dates were recorded. (NCT02554383)
Timeframe: Days 2 to 11, where Day 1 is day of enrollment. The mean number of days of follow-up in this interval was 9.8.

,
InterventionParticipants (Count of Participants)
Developed AOMDid not develop AOM
Amoxicillin-clavulanate0251
Placebo8248

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Changes in Blood Pressure in Response to IV Cocaine With and Without CLAV Dosing

IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min pre-infusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean systolic blood pressure (SBP) and diastolic blood pressure (DBP) at 2 minutes post IV cocaine infusion are reported. Also, the maximum (max) change in SBP snd DBP from baseline pre-infusion are reported (peak SBP or DBP post-infusion minus baseline SBP or DBP pre-infusion) are reported. (NCT02563769)
Timeframe: 4 Days (Study Days 2, 3, 4, 5)

,,,
Interventionmm Hg (Mean)
SBP at 2 minMax change in SBPDBP at 2 mimMax change in DBP
CLAV 250mg135.023.588.813.3
CLAV 500mg140.018.489.512.6
Day 5--CLAV 750mg137.820.987.812.7
Placebo (PBO)138.821.688.512.1

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Change in Heart Rate in Response to IV Cocaine Infusion With and Without CLAV Dosing

IV cocaine was infused 1 hour following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg and vital signs were checked at -15min,-10min, -5 min preinfusion of IV cocaine and then every 2 min for the first 30 minutes, then every 15min through 150 minutes post-infusion. The mean heart rate (HR) at 2 minutes post IV cocaine infusion and the maximum (max) change in heart rate from baseline pre-infusion are reported (peak heart rate post-infusion minus baseline heart rate pre-infusion) are reported. (NCT02563769)
Timeframe: 4 Days (Study Days 2, 3, 4, 5)

,,,
Interventionbeats per minute (Mean)
HR at 2 minMax change in HR from baseline
CLAV 250mg78.029.8
CLAV 500mg86.832.0
Day 5--CLAV 750mg91.027.7
Placebo (PBO)82.226.3

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Pharmacokinetic (PK) Parameter of Cocaine-concentration

Cocaine concentrations are reported at 10 min and 30 minutes after cocaine infusion (70 and 90 minutes after administration of placebo (PBO), CLAV 250mg or CLAV 500mg). (NCT02563769)
Timeframe: 3 Days (Study Days 2, 3, 4)

Interventionmg/L (Mean)
Placebo (PBO) Group-10 Min Cocaine PK0.355
PBO Group-30 Min Cocaine PK0.240
CLAV 250mg Group-10 Min Cocaine PK0.372
CLAV 250mg Group-30 Min Cocaine PK0.215
CLAV 500mg Group-10 Min Cocaine PK0.344
CLAV 500mg Group-30 Min Cocaine PK0.209

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Number of Participants With Severe Adverse Events (AEs)

"Rates of occurrence of serious adverse events across the different treatments: Day 1-IV cocaine only; Day 2.3 and 4 treatment with either PBO, CLAV 250mg or CLAV 500mg depending on randomization; Day 5 CLAV 750mg, Day 10 Follow-up appointment~See Adverse Event section for reporting of mild-moderate AEs." (NCT02563769)
Timeframe: 6 Days (Study Days 1, 2, 3, 4, 5, 10)

InterventionParticipants (Count of Participants)
Day 1 - IV Cocaine Only0
Placebo (PBO)0
CLAV 250mg0
CLAV 500mg0
Day 5--CLAV 750mg0
Day 10--Follow up0

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Electrocardiogram (ECG) Following IV Cocaine With and Without CLAV Dosing

ECG was done 15 min after IV cocaine infusion (following the dosing of PBO or CLAV 250mg, CLAV 500mg and CLAV 750 mg). The interval between the Q wave and the T wave, corrected (QTc) is reported. (NCT02563769)
Timeframe: 4 Days (Study Days 2, 3, 4, 5)

Interventionms (Mean)
Placebo (PBO)431.8
CLAV 250mg432.3
CLAV 500mg430.5
Day 5--CLAV 750mg431.3

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Difference in CLAV Concentrations Between the 250mg and 500mg CLAV Doses

The CLAV concentration after ingestion of 250mg CLAV minus the CLAV PK level after the 500 mg dose is reported at 40min and 70 min after ingestion (NCT02563769)
Timeframe: 3 days (Day 2, 3, 4)

Interventionmg/L (Median)
40 Minute Time Point After 250mg CLAV vs. 500mg CLAV0.227
70 Minute Time Point After 250mg CLAV vs. 500mg CLAV0.331

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Clavulanic Acid (CLAV) Concentrations Following CLAV 250mg and CLAV 500mg Doses

"CLAV concentrations were measured 40 min and 70 min after ingestion of CLAV 250 mg or 500 mg. (The 70 min time point is 10 min after the IV cocaine infusion).The 250mg dose and the 500mg dose were given on different days per the randomization protocol: the 250mg dose was given on either day 2 or 3 and the 500mg dose was given on either day 3 or 4.~The lowest level of detection of CLAV is 40ng/ml. A non-detectable level is reported as 0." (NCT02563769)
Timeframe: 3 Days (Study Days 2, 3, 4)

Interventionmg/L (Median)
CLAV PK at 250mg Dose--40 Min Time Point0.036
CLAV PK at 250mg Dose--70 Min Time Point0.506
CLAV PK at 500mg Dose--40 Min Time Point0.394
CLAV PK at 500mg Dose--70 Min Time Point1.912

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Pupil Pharmacodynamic Effects of Cocaine With Clavulanic Acid

Pupil Diameter (mm) was measured 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion. Cocaine infusion was done 1 hour following ingestion of placebo (day 2), CLAV 250 mg (day3), or CLAV 500 mg (day 4). Results are reported as median pupil diameter (mm) with interquartile range at different time points relative to the cocaine infusion as noted. (NCT02563769)
Timeframe: 10 minutes pre-infusion and 10, 15, 30 and 45 min after cocaine infusion on Study Days 2, 3, and 4

,,
Interventionmm (Median)
-10 min pre-infusion10 min post-infusion15 min post-infusion30 min post-infusion45 min post-infusion
CLAV 250mg3.103.703.403.303.10
CLAV 500mg3.203.903.503.353.10
Placebo (PBO)3.13.553.553.63.4

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The Distribution of Children With a Penicillin-Nonsusceptible Nasopharyngeal or Throat Isolate At Any Follow-up Visit According to the Colonization Status at Enrollment

Throat specimens were obtained mainly from children older than 24 months of age. The penicillin-nonsusceptible pathogens considered are penicillin-intermediate and penicillin-resistant Streptococcus pneumoniae and ß-lactamase-positive Haemophilus influenzae. Susceptibility to penicillin was defined as follows: susceptible as a minimum inhibitory concentration (MIC) of <0.1 μg/mL; intermediate as an MIC of 0.1 to 1μg/mL; and resistant as an MIC of >1 μg/mL. (NCT02567825)
Timeframe: Day 1 until Day 786.

InterventionParticipants (Count of Participants)
No pathogens at enrollment72440667No pathogens at enrollment72440668Positive only for at least 1 penicillin-susceptible pathogen at enrollment72440667Positive only for at least 1 penicillin-susceptible pathogen at enrollment72440668Positive for at least 1 penicillin-nonsusceptible pathogen at enrollment72440667Positive for at least 1 penicillin-nonsusceptible pathogen at enrollment72440668
Penicillin-nonsusceptible isolate at a follow-up vNo penicillin-nonsusceptible isolate at a follow-u
Surgical Management25
Non-Surgical Management24
Surgical Management12
Non-Surgical Management11
Surgical Management22
Non-Surgical Management20
Surgical Management11
Non-Surgical Management15
Surgical Management38
Non-Surgical Management34
Surgical Management5
Non-Surgical Management9

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The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year According to the Estimated Risk of Acute Otitis Media (AOM) Recurrences at Enrollment

An episode of AOM is considered a discrete occurrence if symptoms and signs persisted for, or recurred, >=17 days after the start of antimicrobial treatment. The rate is calculated by dividing the total # of occurrences by the total # of years of follow-up. Risk of recurrences was based on early age of onset of AOM; numerous and/or frequent previous AOM episodes; receipt of multiple courses of antibiotic; eligibility for enrollment first evident during warm-weather months; parental characterization of previous AOM episodes as severe; eligibility for enrollment despite nonexposure to other young children; moderate or marked tympanic membrane (TM) bulging with previous AOM episodes; most previous AOM episodes in both ears; and a high score on the Acute Otitis Media Severity of Symptom scale (with scores ranging from 0 to 10 and higher scores indicating greater severity of symptoms) during screening and/or at enrollment. Multiple imputation was used when follow-up was incomplete. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed.

,
InterventionOccurrences per child-year (Mean)
Children considered at low risk of AOM recurrenceChildren considered at high risk of AOM recurrence
Non-Surgical Management1.561.56
Surgical Management1.281.67

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The Mean Scores on the 6 Item Quality of Life Survey Questionnaire (OM-6)

The OM-6 is a 6 item quality of life assessment addressing physical suffering, hearing loss, speech impairment, emotional distress, activity limitations and caregiver concerns. Responses are regarded on an ordinal scale ranging from 1 (no problem) to 7 (greatest problem). The average response, i.e., score, for these 6 items is calculated. The overall child's quality of life (QOL) score, also captured on the OM-6, is expressed on an ordinal response scale that ranges from 0 (worst quality of life) to 10 (best quality). A OM-6 is administered to the parent every 16 weeks after randomization and occasionally at sick visits. (NCT02567825)
Timeframe: Day 1 until Day 786.

,
InterventionScore on a scale (Mean)
OM-6 survey scoreOM-6 survey--Children's overall QOL score
Non-Surgical Management1.558.37
Surgical Management1.58.45

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The Mean Scores on the 6 Item Caregiver Impact Questionnaire (CIQ)

The Caregiver Impact Questionnaire (CIQ) is a 6 item assessment addressing lack of sleep, absence from work or education, canceling of family activities, changing daily activities, feeling nervous and feeling helpless. Each of these responses is expanded to a continuous scale from 0 (no impact on caregiver) to 100 (greatest impact). The average response, i.e., score, for these 6 items is calculated. The overall caregiver's quality of life (QOL) score, also captured on the CIQ, is expressed on a ordinal response scale that ranges from 0 (worst quality of life) to 10 (best quality). The CIQ is administered to the parent every 16 weeks after randomization and occasionally at sick visits. (NCT02567825)
Timeframe: Day 1 until Day 786.

,
InterventionScore on a scale (Mean)
Caregiver impact questionnaire scoreCaregiver impact questionnaire--Caregiver's overall QOL score
Non-Surgical Management10.938.50
Surgical Management10.828.55

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The Mean Days Per Year Children Experience AOM Symptoms With an Intact Tympanic Membrane (TM)

For a given child, if a day of follow-up coincides with a study visit, the status of the right and left TMs are recorded at the ear exam. If a day of follow-up does not coincide with a study visit the status of each TM is assumed to be the same as the status on the prior day. Scores are used from the 5-item Acute Otitis Media Severity of Symptoms (AOM-SOS) scale (version 4.0) in which parents are asked to rate symptoms, as compared with the child's usual state, as none, a little, or a lot, with corresponding scores of 0, 1, and 2. Total scores range from 0 to 10, with higher scores indicating greater severity of symptoms. Scores are recorded at study visits and on diaries. The total number of days with an intact TM and a AOM-SOS score greater than or equal to 1 is divided by the total number of years of follow-up to arrive at the days per year with AOM symptoms and an intact TM. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years.

InterventionDays per year (Mean)
Surgical Management2.00
Non-Surgical Management8.33

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The Mean Days Per Year Children Experience Tube Otorrhea

Adverse events, including tube-associated otorrhea, were collected from enrollment through the end of study. Each study visit included a review of adverse events. Any such event that occurred since the previous visit was recorded, including the date of onset and the date of resolution. For each child, the days per year of tube otorrhea is calculated by dividing the total number of days of tube otorrhea (based on dates of onset and resolution) by the total number of years of follow-up. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years.

InterventionDays per year (Mean)
Surgical Management7.96
Non-Surgical Management2.83

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The Mean Days Per Year Children Receive Systemic Antimicrobials for AOM

Systemic antibiotics include Amoxicillin-Clavulanate, Ceftriaxone, Cefdinir, Amoxicillin, Azithromycin, Clindamycin, Levofloxacin, Bactrim, Cefprozil, Omnicef and Trimethoprim-Sulfamethoxazole. The days per year, for each child, is calculated by dividing the total number of days the child receives systemic antimicrobials for AOM (based on the recorded start and stop dates) by the total number of years of follow-up. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of follow-up was 662 days / 1.8 years.

InterventionDays per year (Mean)
Surgical Management8.76
Non-Surgical Management12.92

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The Mean Score Representing Parental Satisfaction With Clinical Management

At the end-of-study visit, parents were asked to rate their level of satisfaction with their child's assigned management using a 5-point scale with higher numbers indicating greater satisfaction, specifically 1 = very dissatisfied, 2 = somewhat dissatisfied, 3 = neither satisfied nor dissatisfied, 4 = somewhat satisfied, and 5 = very satisfied. (NCT02567825)
Timeframe: The end-of-study visit. The mean day for this visit was 726.

InterventionScore on a scale (Mean)
Surgical Management4.64
Non-Surgical Management4.43

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The Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year

An episode of AOM is considered a discrete occurrence if symptoms and signs persisted for, or recurred, 17 or more days after the start of antimicrobial treatment. The rate is calculated by dividing the total number of occurrences by the total number of years of follow-up. Multiple imputation was used when follow-up was incomplete. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years. For each child with incomplete 2-year follow-up, multiple imputation was used and values for the remaining days/years were imputed.

InterventionOccurrences per child-year (Mean)
Surgical Management1.48
Non-Surgical Management1.56

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The Total Cost of Management of Recurrent Acute Otitis Media Per Quality Adjusted Life Days (QALDs) as a Measure of Cost-Effectiveness

Total costs in US dollars were calculated by summing costs of lost wages, office visits, medical procedures, hospitalizations, and medications. Total QALDs were calculated by summing daily utility values. A utility value of 1.0 was assumed for days without AOM, otorrhea, or hospitalization. For days where these states were reported, published utility values associated with each state were used. To arrive at the final measure, total costs were divided by total utility values. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years.

InterventionUS dollars per quality adjusted life day (Number)
Surgical Management7.19
Non-Surgical Management5.79

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The Time to the First Episode of AOM

The time to the first episode of AOM is defined as the time, expressed in months, from randomization until the first episode of AOM. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of follow-up was 662 days / 21.8 months.

InterventionMonths (Median)
Surgical Management4.34
Non-Surgical Management2.33

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The Total Cost of Management of Recurrent Acute Otitis Media Per Quality Adjusted Life Days (QALDs) as a Measure of Cost-Effectiveness According to the Estimated Risk of Acute Otitis Media Recurrences at Enrollment

Total costs in US dollars were calculated by summing costs of lost wages, office visits, medical procedures, hospitalizations, and medications. Total QALDs were calculated by summing daily utility values. A utility value of 1.0 was assumed for days without AOM, otorrhea, or hospitalization. For days where these states were reported, published utility values associated with each state were used. To arrive at the final measure, total costs were divided by total utility values. The estimated risk of AOM at enrollment is described under both Baseline Characteristics and Outcome Measure #2. (NCT02567825)
Timeframe: Day 1 until Day 786. The mean length of actual follow-up was 662 days / 1.8 years.

,
InterventionUS dollars per quality adjusted life day (Number)
Children considered at low risk of AOM recurrenceChildren considered at high risk of AOM recurrence
Non-Surgical Management5.705.91
Surgical Management6.258.00

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Summary of Clinical Cure

Clinical cure was assessed using the latest efficacy evaluation conducted on Day 16 (+/- 4 days) post-randomization, and was defined as resolution of all presenting signs/symptoms of CABP (excluding cough), no development of new signs/symptoms of CABP, and no requirement for an additional antibiotic. (NCT02605122)
Timeframe: Short-term follow-up at 16 days (+/- 4 days)

Interventionpercentage of participants (Number)
Solithromycin60.0
Standard of Care68.4

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Overview of Adverse Events By Treatment Arm

Summary of subjects experiencing Treatment Emergent Adverse Events (TEAE) through Day 16 visit and Treatment Emergent Serious Adverse Events (TESAE) through Day 28 visit (28 days +/- 4 days after randomization) (NCT02605122)
Timeframe: Up to 28 days post-treatment

,
InterventionParticipants (Count of Participants)
TEAETESAE
Solithromycin241
Standard of Care71

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Summary of Early Clinical Response

Early clinical response (ECR) was defined using the latest efficacy evaluation from Day 2 (if subject discharged prior to Day 2), Day3, or Day 4, and was defined as improvement in at least 1 presenting sign/symptom of CABP with no deterioration in any signs/symptoms of CABP and no requirement for an additional antibiotic. (NCT02605122)
Timeframe: During Treatment Days 3 to 4

Interventionpercentage of participants (Number)
Solithromycin66.7
Standard of Care46.7

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Summary of Clinical Improvement

Clinical improvement was assessed using the latest efficacy evaluation conducted on last day of treatment (+48 hours), and was defined identically to the early clinical response. (NCT02605122)
Timeframe: Last day of Treatment (+48 hours)

Interventionpercentage of participants (Number)
Solithromycin64.5
Standard of Care81

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Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 2

"Participants treated with formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Plasma concentration of amoxicillin 40 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child." (NCT02630992)
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.

Interventionmicrograms per milliliter (mcg/ml) (Mean)
0.5 hours (approximate)1.5 hours (approximate)2.0 hours (approximate)2.5 hours (approximate)3.0 hours (approximate)3.5 hours (approximate)4.0 hours (approximate)
Amoxicillin-clavulanate Potassium8.637.497.7610.2213.0010.368.52

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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 1

"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Plasma concentration of clavulanate 1.6 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child." (NCT02630992)
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.

Interventionnanograms per milliliter (ng/ml) (Mean)
0.5 hours (approximate)1.5 hours (approximate)2.0 hours (approximate)3.0 hours (approximate)3.5 hours (approximate)4.0 hours (approximate)
Amoxicillin-clavulanate Potassium1047.672050730.50338842313.80

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Distribution of Population Plasma Concentration of Clavulanate According to Time For Participants Receiving Formulation 2

"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Plasma concentration of clavulanate 1.425 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child." (NCT02630992)
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.

Interventionnanograms per milliliter (ng/ml) (Mean)
0.5 hours (approximate)1.5 hours (approximate)2.0 hours (approximate)2.5 hours (approximate)3.0 hours (approximate)3.5 hours (approximate)4.0 hours (approximate)
Amoxicillin-clavulanate Potassium407655.501125.33660.16986.95866.00555.50

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The Distribution of Participants Receiving Formulation 1 for Whom Diaper Dermatitis Was Reported and Associated With Study Product

"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product." (NCT02630992)
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.

InterventionParticipants (Count of Participants)
Diaper dermatitis reportedDiaper dermatitis not reported
Amoxicillin-clavulanate Potassium1030

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The Distribution of Participants Receiving Formulation 1 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product

"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product." (NCT02630992)
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.

InterventionParticipants (Count of Participants)
PDD reportedPDD not reported
Amoxicillin-clavulanate Potassium1030

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The Distribution of Participants Receiving Formulation 2 Categorized as Treatment Failure (TF) at or Before the End-of-Treatment Visit

"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Treatment failure is defined as substantial persistence or worsening of symptoms specifically attributable to AOM or of otoscopic signs of acute inflammation (bulging of the TM or intense erythema) after 72 hours from the initial AOM, such that additional antimicrobial therapy is deemed advisable. Clinical success is defined as complete or substantial resolution of symptoms specifically attributable to AOM for 48 hours and of otoscopic signs of acute inflammation (bulging of the TM or intense erythema), with or without persistence of middle-ear effusion, such that no additional antibiotic therapy is deemed advisable." (NCT02630992)
Timeframe: From 72 hours after the initial AOM until the end-of-treatment visit. The mean day for this visit was 13.9.

InterventionParticipants (Count of Participants)
Treatment failureClinical success
Amoxicillin-clavulanate Potassium856

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The Distribution of Participants Receiving Formulation 2 for Whom Diaper Dermatitis Was Reported and Associated With Study Product

"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Diaper dermatitis is defined as dermatitis in the diaper area calling for prescription of a topical antifungal agent and is limited to events associated with study product.." (NCT02630992)
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.

InterventionParticipants (Count of Participants)
Diaper dermatitis reportedDiaper dermatitis not reported
Amoxicillin-clavulanate Potassium1557

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The Distribution of Participants Receiving Formulation 2 for Whom Protocol-Defined Diarrhea (PDD) Was Reported and Associated With Study Product

"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~Protocol-defined diarrhea is defined as the occurrence of three or more watery stools in 1 day or two watery stools daily for 2 consecutive days and is limited to events associated with study product." (NCT02630992)
Timeframe: Day 1 of administration of amoxicillin-clavulanate until day 12.

InterventionParticipants (Count of Participants)
PDD reportedPDD not reported
Amoxicillin-clavulanate Potassium1260

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The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 1

"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively." (NCT02630992)
Timeframe: The end-of-treatment visit. The mean day for this visit was 14.9.

Interventionunits on a scale (Mean)
Amoxicillin-clavulanate Potassium4.69

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The Mean Score Representing the Parent or Guardian's Level of Satisfaction With Therapy for Participants Receiving Formulation 2

"Participants receiving formulation 2 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 80/2.85 mg/kg/day in two divided doses for 10 days.~The parent or guardian will answer a questionnaire regarding their satisfaction with the therapy their child received. The responses 'very dissatisfied', 'somewhat dissatisfied', 'neither satisfied nor dissatisfied', 'somewhat satisfied' and 'very satisfied' correspond to scores of 1, 2, 3, 4, and 5, respectively." (NCT02630992)
Timeframe: The end-of-treatment visit. The mean day for this visit was 13.9.

Interventionunits on a scale (Mean)
Amoxicillin-clavulanate Potassium4.75

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Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1

"Participants receiving formulation 1 were administered amoxicillin-clavulanate potassium containing a reduced concentration of clavulanate potassium, 600 mg/21.5 mg/5 mL (a ratio of 28:1), administered at 90/3.2 mg/kg/day in two divided doses for 10 days.~Plasma concentration of amoxicillin 45 mg/kg/dose was measured.~Data points up to 4 hours with a standard deviation of 0 indicate that the assessment was available for only one child." (NCT02630992)
Timeframe: From administration of a single dose of amoxicillin-clavulanate until approximately 4 hours after.

Interventionmicrograms per milliliter (mcg/ml) (Mean)
0.5 hours (approximate)1.5 hours (approximate)2.0 hours (approximate)3.0 hours (approximate)3.5 hours (approximate)4.0 hours (approximate)
Amoxicillin-clavulanate Potassium14.3615.311.428.079.787.39

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Number of Participants With Wound Infections

Number of Wound Infections, 30-days postoperative (NCT02724410)
Timeframe: Thirty days following appendectomy

InterventionParticipants (Count of Participants)
Home Intravenous Ertapenem and PICC1
Home Oral Amoxicillin-clavulanate2

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Number Participants With Readmission Within 30 Days

Number of Readmission within 30 days postoperative (NCT02724410)
Timeframe: Thirty days following appendectomy

InterventionParticipants (Count of Participants)
Home Intravenous Ertapenem and PICC6
Home Oral Amoxicillin-clavulanate6

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Number of Participants With Postoperative Abscess

Number of Postoperative Abscess, thirty-day postoperative (NCT02724410)
Timeframe: Thirty days after appendectomy

InterventionParticipants (Count of Participants)
Home Intravenous Ertapenem and PICC5
Home Oral Amoxicillin-clavulanate3

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Hospital Charge

Cost of Hospital services (NCT02724410)
Timeframe: Thirty days following appendectomy

InterventionDollars (Mean)
Home Intravenous Ertapenem and PICC47564.3
Home Oral Amoxicillin-clavulanate34227.79

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Days in Hospital After Index Treatment Within 90 Days

Mean number of days in the hospital per participant calculated at 90 days post randomization. (Number of days/Number of Participants in Therapy Arm who responded to the 90 day survey question) (NCT02800785)
Timeframe: 90 days post randomization

InterventionDays per participant (rate) (Mean)
Antibiotics Therapy Arm0.68
Appendectomy Arm0.15

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Rates of Participants With Appendiceal Cancer

Rates of appendiceal cancer among participants will be calculated among the antibiotics and appendectomy arms. (NCT02800785)
Timeframe: Through study completion, up to 2 years

InterventionParticipants (Count of Participants)
Antibiotics Therapy Arm4
Appendectomy Arm6

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Eventual Appendectomy Incidence Proportion

incidence proportion of appendectomy within 90 days post randomization among those randomized to antibiotics (NCT02800785)
Timeframe: 90 days post randomization

Interventionincidence proportion (Number)
Antibiotics Therapy Arm0.29

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Number of Clinic Visits or Emergency Room Visits

Total number of participants with any visit to emergency department or urgent care clinic after index treatment within 90 days (NCT02800785)
Timeframe: 90 days post randomization

Interventionvisits (Number)
Antibiotics Therapy Arm55
Appendectomy Arm26

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Total Number of Patients Who Had Resolution of Appendicitis Symptoms at 30 Days

Total Number of Patients who had resolution of appendicitis symptoms at 30 Days. This was measured as absence of fever and abdominal pain and tenderness. (NCT02800785)
Timeframe: at 30 days

InterventionParticipants (Count of Participants)
Antibiotics Therapy Arm462
Appendectomy Arm466

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Rate of Participants With Perforated Appendicitis

Rates of patients who had perforated appendicitis will be calculated for each arm among those received an appendectomy. (NCT02800785)
Timeframe: 90 days post enrollment

InterventionParticipants (Count of Participants)
Antibiotics Therapy Arm59
Appendectomy Arm99

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Patient-reported Quality of Life as Measured by EuroQol (EQ-5D)

The primary evaluation of patient-reported quality of life, as measured by the EuroQuol-5D at four-weeks, will be conducted using an intention-to-treat (ITT) analysis, where patients' data are analyzed according to the patients' randomized treatment assignment. EQ5D assesses health status in terms of five dimensions of health. The maximum score of 1 indicates the best health state, the minimum score is 0 (as score as bad as being dead). (NCT02800785)
Timeframe: Four-weeks after randomization

Interventionscore on a scale (Mean)
Antibiotics Therapy Arm0.92
Appendectomy Arm0.91

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Number of Participants With at Least One Complications From Treatment

Comparison of the number of participants with at least one surgical complication and antibiotic complications. (NCT02800785)
Timeframe: 90 days

InterventionParticipants (Count of Participants)
Antibiotics Therapy Arm37
Appendectomy Arm21

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Resolution of Symptoms (a Component of DOOR)

This table provides number and percentage of subjects who experienced lack of resolution of symptoms by their OAV #2. (NCT02891915)
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)

,
InterventionParticipants (Count of Participants)
Lack of Resolution of SymptomsFeverElevated respiratory rateCough
Short Course9026
Standard Course11315

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Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits

This table provides number and percentage of subjects who received non-study antibiotics for any use from Day 1 to Day 5 (NCT02891915)
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)

,
InterventionParticipants (Count of Participants)
ED or Clinic VisitReceipt of Non-Study Antibiotic
Short Course22
Standard Course11

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Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits

This table provides number and percentage of subjects who received non-study antibiotics for any reason from Day 1 to Day 18 (NCT02891915)
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)

,
InterventionParticipants (Count of Participants)
ED or Clinic VisitReceipt of Non-Study Antibiotic
Short Course2918
Standard Course3211

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Adequate Clinical Response Rates (a Component of DOOR)

Lack of adequate clinical response at OAV #2 is defined as the presence of a medically attended visit to an ED or outpatient clinic or hospitalization or receipt of non-study antibiotics or surgical procedures for persistent or worsening pneumonia from Day 1 to Day 18. (NCT02891915)
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)

,
InterventionParticipants (Count of Participants)
Lack of Adequate Clinical ResponseED or Clinic VisitReceipt of Non-Study AntibioticHospitalizationSurgical Procedure
Short Course24200
Standard Course32300

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Adequate Clinical Response Rates (a Component of DOOR)

Lack of adequate clinical response at OAV #1 is defined as the presence of a medically attended visit to an Emergency Department (ED) or outpatient clinic or hospitalization or receipt of non-study antibiotics or surgical procedures for persistent or worsening pneumonia from Day 1 to Day 5. (NCT02891915)
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)

,
InterventionParticipants (Count of Participants)
Lack of Adequate Clinical ResponseED or Clinic VisitReceipt of Non-Study AntibioticHospitalizationSurgical Procedure
Short Course22200
Standard Course11100

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Number of Participants Receiving Non-study Systemic Antibiotics for All Causes During Medically Attended Visits

This table provides number and percentage of subjects who received non-study antibiotics for any reason from Day 1 to Day 5 (NCT02891915)
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)

,
InterventionParticipants (Count of Participants)
ED or Clinic VisitReceipt of Non-Study Antibiotic
Short Course87
Standard Course72

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Resolution of Symptoms (a Component of DOOR)

This table provides number and percentage of subjects who experienced lack of resolution of symptoms by their OAV #1. (NCT02891915)
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)

,
InterventionParticipants (Count of Participants)
Lack of Resolution of SymptomsFeverElevated respiratory rateCough
Short Course12227
Standard Course13174

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Number of Participants Reporting Solicited Symptoms

This table summarizes the number and percentage of subjects experiencing any solicited events of mild, moderate or severe severity from Day 1 to Day 5 (NCT02891915)
Timeframe: Outcome Assessment Visit 1 (Study Day 8 +/- 2 days)

,
InterventionParticipants (Count of Participants)
Any EventIrritabilityVomitingDiarrheaAllergic ReactionStomatitisCandidiasis
Short Course745211231514
Standard Course684311211534

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Number of Participants Reporting Solicited Symptoms

This table summarizes the number and percentage of subjects experiencing any solicited events of mild, moderate or severe severity from Day 1 to Day 18 (NCT02891915)
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)

,
InterventionParticipants (Count of Participants)
Any EventIrritabilityVomitingDiarrheaAllergic ReactionStomatitisCandidiasis
Short Course916719332217
Standard Course896024302167

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Number of Participants Receiving Non-study Systemic Antibiotics for Persistent or Worsening Pneumonia During Medically Attended Visits

This table provides number and percentage of subjects who received non-study antibiotics for any use from Day 1 to Day 18 (NCT02891915)
Timeframe: Outcome Assessment Visit 2 (Study Day 22 +/- 3 days)

,
InterventionParticipants (Count of Participants)
ED or Clinic VisitReceipt of Non-Study Antibiotic
Short Course42
Standard Course23

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Estimate the Antimycobacterial Activity Based on Liquid Culture Time-to-positivity

Change in time-to-positivity in Mycobacteria Growth Indicator Tube (MGIT) liquid media over 14 days of treatment (EBA0-14(TTP)) (time to positivity) for the study treatments. The Early Bactericidal Activity (EBA) over a 14 days period (EBA0-14), as determined by the median rate of change in TTP (expressed in log10 hours/day). A non-linear mixed effects model of log10 hours/day on time was developed using aggregated participant data for each treatment arm. A basic model was developed based on mono- or bi-exponential bacterial killing functions. Afterwards, covariate modelling to identify relationships between demographics, disease severity, secondary pharmacokinetic summary indices (area under the curve from time 0 to last measured concentration (AUC0-last) and maximum observed plasma concentration (Cmax), and model parameters describing TTP over time was performed. Finally, the treatment regimen was tested using different functions supported by the graphical analysis. (NCT03174184)
Timeframe: 14 days

Interventionrate of change in log10 hours/day (Mean)
Rifampin Resistant A0.19
Rifampin Resistant B0.31
Rifampin Susceptible C0.53
Rifampin Susceptible D0.20
Rifampin Susceptible E0.09
Rifampin Susceptible F0.09

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Estimate of the 14-day Early Bactericidal Activity (EBA), Based on Colony Forming Unit Counts, of the Combination of Meropenem and Amoxicillin/Clavulanate, Without Versus With Rifampin

The Early Bactericidal Activity (EBA) over a 14 days period (EBA0-14), as determined by the median rate of change in log10 Colony Forming Units (CFU) per mL sputum. A non-linear mixed effects model of log10 CFU/mL sputum on time was developed using aggregated participant data for each treatment arm. A basic model was developed based on mono- or bi-exponential bacterial killing functions. Afterwards, covariate modelling to identify relationships between demographics, disease severity, secondary pharmacokinetic summary indices (area under the curve from time 0 to last measured concentration (AUC0-last) and maximum observed plasma concentration (Cmax), and model parameters describing log10 CFU/mL sputum over time was performed. Finally, the treatment regimen was tested using different functions supported by the graphical analysis. (NCT03174184)
Timeframe: 14 days

Interventionrate of change in log10 CFU/mL/day (Mean)
Rifampin Resistant A-0.06
Rifampin Resistant B-0.11
Rifampin Susceptible C-0.14
Rifampin Susceptible D-0.12
Rifampin Susceptible E-0.05
Rifampin Susceptible F-0.02

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Distribution of Minimum Inhibitory Concentration (MIC) of Rifampin

The distribution of rifampin MIC in the drug-resistant arms (NCT03174184)
Timeframe: 14 days

Interventionmcg/mL (Median)
Rifampin Resistant A1.28
Rifampin Resistant B1.28

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AUC for Rifampin

Rifampin AUC0-last in Arms A and C (NCT03174184)
Timeframe: 14 days

Interventionh*mg/L (Mean)
Rifampin Resistant A105
Rifampin Susceptible C109

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Frequency of Grade 2 or Higher Adverse Events

Grade 2 or higher Adverse Events (AE) that constitute any untoward medical occurrence in a study participant and which does not necessarily have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not related to the medicinal product. (NCT03174184)
Timeframe: From the time a study participant receives the first dose of study drug through the final study visit, up to 28 days

InterventionEvents (Number)
Rifampin Resistant A28
Rifampin Resistant B15
Rifampin Susceptible C5
Rifampin Susceptible D8
Rifampin Susceptible E3
Rifampin Susceptible F7

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Percentage of Participants With Microbiologic Success

Microbiologic success is defined as demonstrating <1000 CFU/mL of the baseline urpathogen by quantitative urine culture (NCT03357614)
Timeframe: Day 21 +/- 1 day

InterventionParticipants (Count of Participants)
Sulopenem316
Ertapenem343

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Percentage of Participants With Overall Success

Clinical success is defined as complete resolution of cUTI symptoms present at study entry and no new cUTI symptoms; microbiologic success is defined as eradication of the bacterial pathogen found at study entry (reduced to <1000 CFU/mL) (NCT03357614)
Timeframe: Day 21 +/- 1 day

InterventionParticipants (Count of Participants)
Sulopenem301
Ertapenem325

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Percentage of Participants With Clinical Success

Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions (NCT03358576)
Timeframe: Day 28 +/- 1 day

Interventionpercentage of participants (Number)
Sulopenem85.5
Ertapenem90.2

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Percentage of Participants With Clinical Success

Clinical response is defined as resolution in signs and symptoms of the index infection and no new symptoms, without the need for additional antibiotics or interventions (NCT03358576)
Timeframe: Day 11-14 +/- 1 day

InterventionParticipants (Count of Participants)
Sulopenem208
Ertapenem227

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Level of Fecal SCFA Butyrate

Level of fecal short-chain fatty acid butyrate (μM) after administration of amoxicillin clavulanate (NCT03755765)
Timeframe: day 0 (post run-in), 7, 14, 21, 30

,
InterventionμM (Mean)
Day 0Day 7Day 14Day 21Day 30
BB-1212.78.38.911.99.9
Control12.79.07.411.68.3

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Level of Fecal SCFA Propionate

Level of fecal short-chain fatty acid propionate after administration of amoxicillin clavulanate (NCT03755765)
Timeframe: day 0 (post run-in), 7, 14, 21, 30

,
InterventionμM (Mean)
Day 0Day 7Day 14Day 21Day 30
BB-1213.012.512.014.811.5
Control14.314.311.811.011.4

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Level of Fecal Short-chain Fatty Acid (SCFA) Acetate

Level of fecal short-chain fatty acid acetate (SCFA) after administration of amoxicillin clavulanate (NCT03755765)
Timeframe: day 0 (post run-in), 7, 14, 21, 30

,
Interventionmicromolar (μM) (Mean)
Day 0Day 7Day 14Day 21Day 30
BB-1245.238.140.850.544.5
Control53.142.336.843.839.8

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Change in Community Diversity (Shannon Diversity Index) From Post run-in Baseline

The Shannon diversity metric is a measure of community diversity and takes into account species richness (number of distinct taxa) and the relative abundance of each taxon. The Shannon diversity index was calculated for samples at each time point from subjects receiving control or BB-12 yogurt. The second baseline sample was collected from each subject after a 30-day run-in period in which the consumption of dietary probiotics was stopped (post run-in). A higher index indicates more diversity and a lower index indicates less diversity. (NCT03755765)
Timeframe: day 0 (post run-in), 7, 14, 21, 30

,
InterventionShannon Diversity Index (Mean)
Day 0 Post run-inDay 7Day 14Day 21Day 30
BB-123.7183.6063.6663.7273.712
Control3.8453.5283.4963.7853.486

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Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline

The Shannon diversity metric is a measure of community diversity and takes into account species richness (number of distinct taxa) and the relative abundance of each taxon. The Shannon diversity index was calculated for samples at each time point from subjects receiving control or BB-12 yogurt. The first of two baseline samples was collected from each subject at the time of enrollment (pre run-in) before a 30-day run-in period in which the consumption of dietary probiotics was stopped. A higher index indicates more diversity and a lower index indicates less diversity. (NCT03755765)
Timeframe: day 0 (pre run-in), 7, 14, 21, 30

,
InterventionShannon Diversity Index (Mean)
Day 0 Pre run-inDay 7Day 14Day 21Day 30
BB-123.7743.5673.6323.7083.684
Control3.7113.3803.4193.7093.395

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Evaluation of Efficacy (Otoscopy)

Percentage of study participants with no bulging tympanic membrane (NCT03818815)
Timeframe: Day 4

InterventionPercentage of participants (Number)
Drug: OP0201 + Antibiotics51
Placebo Comparator: Placebo + Antibiotics47.3

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Number of Participants With Adverse Events

(NCT03818815)
Timeframe: Days 1-28

InterventionParticipants (Count of Participants)
Drug: OP0201 + Antibiotics48
Placebo Comparator: Placebo + Antibiotics36

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Evaluation of Efficacy (Otoscopy)

Percentage of study participants with no middle ear effusion (NCT03818815)
Timeframe: Day 12

InterventionPercentage of participants (Number)
Drug: OP0201 + Antibiotics55.9
Placebo Comparator: Placebo + Antibiotics37.9

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Changes in Resting State Network Connectivity From Baseline

Craving-associated neurocircuitry (frontal-striatal-thalamic connectivity) will be examined with resting state functional Magnetic Resonance Imaging (rs-fMRI) and Cocaine Craving Questionnaire (CCQ-45). The CCQ is comprised of five 9-item sub-scales (desire to use cocaine, intention and planning to use cocaine, anticipation of positive outcome from use, anticipation of relief from withdrawal or dysphoria, and lack of control over use) measured on a scale of 1 to 7, total scores ranging from 45 to 315 with higher numbers indicating increased craving.. The rs-fMRI activity and CCQ were assessed in the 9 participants at baseline and at the end of each of 3 periods. rs-fMRI activity and CCQ were correlated using the Spearman Correlation Coefficient calculation. A negative correlation coefficient indicates an inverse relationship between the assessments; higher rs-fMRI activity correlates with lower craving. (NCT04411914)
Timeframe: Assessment was done at the end of Period 1, 2 and 3 detailed above. Data from the end of Period 3 (Day 10, 1000mg CLAV) are reported.

InterventionSpearman Correlation Coefficient (Number)
Rs-fMRI and CCQ on Day 10 CLAV-0.8333

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Change in Brain Glutamine From Baseline

Change in brain glutamine (Gln) concentration in the ACC at Day 10 compared to baseline as assessed by MRS in the ACC. (NCT04411914)
Timeframe: Brain glutamine will be analyzed at baseline (Day 1 prior to CLAV or PBO dose) and at Day 10 day (having completed Periods 1, 2 and 3 (CLAV 500mg/day for 3 days, 750 mg/day for 3 days and 1000 mg/day for 4 days).

Interventionmmol/kg (Mean)
Clavulanic Acid (CLAV) Group Baseline1.5
Clavulanic Acid Day 102.1
Placebo Group Baseline0.8
Placebo Group Day 100.7

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Brain Glutamate Concentration in the Anterior Cingulate Cortex (ACC) in Subjects With Cocaine Use Disorder (CUD) Treated With Escalating Doses of Clavulanate (CLAV)

Brain glutamate concentration in the ACC (based on Magnetic Resonance Spectroscopy (MRS)) will be correlated with cocaine craving (measured by Cocaine Craving Questionnaire (CCQ)) in subjects receiving escalating doses of CLAV for 10 days. Measurement will be made at baseline and Day 10 of CLAV (1000 mg/day) in subjects with cocaine use disorder. (NCT04411914)
Timeframe: ACC glutamate and CCQ will be measured and correlated on Day 10 of treatment with CLAV compared with baseline.

InterventionSpearman Correlation Coefficient (Number)
Clavulanic Acid Day 10-0.9000
Clavulanic Acid Baseline0.3333

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Craving

Craving will be evaluated by Cocaine Craving Questionnaire (CCQ-45). The CCQ is comprised of five 9-item sub-scales (desire to use cocaine, intention and planning to use cocaine, anticipation of positive outcome from use, anticipation of relief from withdrawal or dysphoria, and lack of control over use) measured on a scale of 1 to 7, total scores ranging from 45 to 315 with higher numbers indicating increased craving. The results are the CCQ scores on day 10 minus the baseline scores before starting study drug. (NCT04411914)
Timeframe: CCQ-45 questionnaires were completed daily during the study. Data from day 10 adjusted for baseline score are reported.

Interventiondifference in score on a scale (Mean)
Male CLAV Subjects--CCQ on Day 107
Male PBO Subjects--CCQ Score Day 10-22
Female CLAV Subjects--CCQ Score Day 10-15
Femaile PBO Subjects--CCQ Scores Day 1049

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