amoxicillin-potassium clavulanate combination profile

Amoxicillin-Potassium Clavulanate Combination: A fixed-ratio combination of amoxicillin trihydrate and potassium clavulanate. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

ID Source	ID
PubMed CID	9808901
MeSH ID	M0029678

Synonym
amoxicillin-potassium clavulanate combination

Excerpt	Reference	Relevance
" The incidence of adverse events was higher in the co-amoxiclav-treated patients (31% versus 15% in the ceftibuten group) as was the incidence of severe events (10% for co-amoxiclav-treated patients versus < 1% in the ceftibuten group)."	( The efficacy and safety of once-daily ceftibuten compared with co-amoxiclav in the treatment of acute bacterial sinusitis. De Abate, CA; Dennington, ML; Perrotta, RJ; Ziering, RM, 1992)	0.28
" Nevertheless, treatment with loracarbef resulted in the lowest rate of discontinuation of therapy due to drug-related adverse events."	( Efficacy and safety of loracarbef in the treatment of pneumonia. Hyslop, DL, 1992)	0.28
" Thirteen out of 181 (7%) patients treated with cefuroxime axetil experienced drug-related adverse events, including 4% with diarrhoea."	( A comparison of the efficacy and safety of cefuroxime axetil and augmentin in the treatment of upper respiratory tract infections. Brown, GW; Cox, DM; Hebblethwaite, EM, 1987)	0.27
" Adverse clinical events were reported in 13% (24) of cefprozil-treated patients and 20% (36) of amoxycillin/clavulanate-treated patients."	( Comparative efficacy and safety of cefprozil and amoxycillin/clavulanate in the treatment of acute otitis media in children. Berche, P; Bingen, E; Boucot, I; Gehanno, P; Gres, JJ; Lambert-Zechovsky, N; Rollin, C, 1994)	0.29
" Clinical adverse events related to the trial medication were reported by 40 (21%) of 189 patients in the fleroxacin group and by 16 (17%) of 95 patients in the AMX/CP group."	( Comparative efficacy and safety of oral fleroxacin and amoxicillin/clavulanate potassium in skin and soft tissue infections. Tassler, H, 1993)	0.29
" Treatment-related or possibly treatment-related adverse events were recorded in 11 of 243 (4."	( Multicentre comparative study of the efficacy and safety of azithromycin compared with amoxicillin/clavulanic acid in the treatment of paediatric patients with otitis media. Principi, N, 1995)	0.29
"This study demonstrated that CFX has comparable clinical efficacy and a better adverse events profile than A/C when used to treat AOM of childhood."	( Comparison of the efficacy, safety and acceptability of cefixime and amoxicillin/clavulanate in acute otitis media. Gooch, WM; Philips, A; Rhoades, R; Rosenberg, R; Schaten, R; Starobin, S, 1997)	0.3
" Rates of adverse events and treatment discontinuations due to adverse events were examined."	( Comparative effectiveness and safety of cefdinir and amoxicillin-clavulanate in treatment of acute community-acquired bacterial sinusitis. Cefdinir Sinusitis Study Group. Gwaltney, JM; Keyserling, C; Leigh, A; Rivas, P; Savolainen, S; Scheld, WM; Schenk, P; Sydnor, A; Tack, KJ, 1997)	0.3
" Adverse events were reported in 10% of the patients treated with azithromycin, and 11."	( An open, multicentre, comparative study of the efficacy and safety of azithromycin and co-amoxiclav in the treatment of upper and lower respiratory tract infections in children. The Paediatric Azithromycin Study Group. Lauvau, DV; Verbist, L, )	0.13
" Both drugs were well tolerated and produced similar incidences of adverse events, which were mostly gastrointestinal."	( A comparison of the efficacy, tolerability and safety of azithromycin and co-amoxiclav in the treatment of sinusitis in adults. Clement, PA; de Gandt, JB, )	0.13
" Hepatic dysfunction is a rare adverse reaction associated with this combination antibiotic."	( An unusual case of amoxicillin/clavulanic acid-related hepatotoxicity. Ehrinpreis, MN; Mutchnick, MG; Nathani, MG; Tynes, DJ, 1998)	0.3
" The adverse event rate was non-significantly lower in the piperacillin/ tazobactam group compared to the co-amoxiclav/aminoglycoside group (2% vs."	( Efficacy, safety, and tolerance of piperacillin/tazobactam compared to co-amoxiclav plus an aminoglycoside in the treatment of severe pneumonia. Grossenbacher, M; Imhof, E; Speich, R; Vogt, M; Zimmerli, W, 1998)	0.3
" Patients from 23 geographically diverse sites were evaluated for clinical outcomes and/or adverse events at Days 3 to 5, Days 15 to 19 and 4 to 6 weeks posttherapy."	( Safety and efficacy of azithromycin in the treatment of community-acquired pneumonia in children. Campbell, M; Cassell, GH; Hammerschlag, MR; Harris, JA; Kolokathis, A, 1998)	0.3
" Treatment-related adverse events occurred in 11."	( Safety and efficacy of azithromycin in the treatment of community-acquired pneumonia in children. Campbell, M; Cassell, GH; Hammerschlag, MR; Harris, JA; Kolokathis, A, 1998)	0.3
" There was no significant difference between the two groups in the incidence or severity of adverse events or in the number of discontinuations because of adverse events."	( Comparison of the efficacy, safety and tolerability of azithromycin and co-amoxiclav in the treatment of acute periapical abscesses. Adriaenssen, CF, )	0.13
" The adverse event profile was comparable between treatment groups."	( The efficacy and safety of a new ciprofloxacin suspension compared with co-amoxiclav tablets in the treatment of acute exacerbations of chronic bronchitis. Berrisoul, F; Kearsley, N; Kubin, R; Kuss, A; Read, RC; Torres, A, 1999)	0.3
" Both treatment regimens were well tolerated, with most adverse events being of a mild-moderate and transient nature."	( Efficacy and safety of amoxycillin/clavulanate (Augmentin) twice daily versus three times daily in the treatment of acute otitis media in children. The Augmentin 454 Study Group. Damrikarnlert, L; Jauregui, AC; Kzadri, M, 2000)	0.31
" The appearance of any adverse events was classified as associated or not associated with the medication of the study."	( Efficacy and safety of cefdinir in the treatment of maxillary sinusitis. Schenk, P; Steurer, M, 2000)	0.31
"01) more related adverse events were found in the co-amoxiclav group."	( Efficacy, safety and tolerability of 3 day azithromycin versus 10 day co-amoxiclav in the treatment of children with acute lower respiratory tract infections. de Groot, R; Ferwerda, A; Hop, WC; Kouwenberg, JM; Moll, HA; Robben, SG; Tjon Pian Gi, CV, 2001)	0.31
"There is a growing body of evidence that amoxicillin-clavulanic acid may induce severe adverse effects in patients."	( Amoxicillin-clavulanic acid therapy may be associated with severe side effects -- review of the literature. Gresser, U, 2001)	0.31
"A medline search of case reports and reviews on amoxicillin-clavulanic acid induced adverse effects was performed."	( Amoxicillin-clavulanic acid therapy may be associated with severe side effects -- review of the literature. Gresser, U, 2001)	0.31
"5 weeks after onset of drug administration (average); three of 153 patients did not survive the adverse event."	( Amoxicillin-clavulanic acid therapy may be associated with severe side effects -- review of the literature. Gresser, U, 2001)	0.31
"Amoxicillin-clavulanic acid which is marketed for treatment of respiratory infections and sinusitis/otitis may in some cases induce severe adverse effects and death in patients of different age, especially if they are on multidrug regimens."	( Amoxicillin-clavulanic acid therapy may be associated with severe side effects -- review of the literature. Gresser, U, 2001)	0.31
" Rx appears to be active and safe in the therapy of ENT diseases exhibiting similar effects on the reduction of signs and symptoms as Amx but with better compliance because of once-a-day administration."	( A multicenter study on the clinical efficacy and safety of roxithromycin in the treatment of ear-nose-throat infections: comparison with amoxycillin/clavulanic acid. Benazzo, M; Mira, E, 2001)	0.31
" Both regimens were well tolerated, with no differences in adverse events between the groups."	( The efficacy and safety of oral pharmacokinetically enhanced amoxycillin-clavulanate 2000/125 mg, twice daily, versus oral amoxycillin-clavulanate 1000/125 mg, three times daily, for the treatment of bacterial community-acquired pneumonia in adults. Chidiac, C; Garau, J; Petitpretz, P; Rouffiac, E; Soriano, F; Stevenson, K, 2002)	0.31
" The drug was well tolerated by the patients and no severe adverse effects were observed."	( Efficacy and safety of sequential amoxicillin-clavulanate in the treatment of anaerobic lung infections. Carratalà, J; Dorca, J; Fernández-Sabé, N; Gudiol, F; Manresa, F; Rosón, B; Tubau, F, 2003)	0.32
" Amoxicillin-clavulanate 2,000/125 mg twice daily was shown to be as clinically effective as amoxicillin-clavulanate 875/125 mg twice daily for 7 days in the treatment of adult patients with community-acquired pneumonia, without a noted increase in the reported rate of adverse events."	( Double-blind, randomized study of the efficacy and safety of oral pharmacokinetically enhanced amoxicillin-clavulanate (2,000/125 milligrams) versus those of amoxicillin-clavulanate (875/125 milligrams), both given twice daily for 7 days, in treatment of Berkowitz, E; File, TM; Kozak, R; Kurz, H; Lode, H; Xie, H, 2004)	0.32
" Both therapies were well tolerated, with a similar incidence of adverse events."	( Efficacy and safety of pharmacokinetically enhanced amoxicillin-clavulanate at 2,000/125 milligrams twice daily for 5 days versus amoxicillin-clavulanate at 875/125 milligrams twice daily for 7 days in the treatment of acute exacerbations of chronic bronc Breton, J; Sethi, S; Wynne, B, 2005)	0.33
" 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
" The adverse events ratio for the two groups was the same (p=0."	( Efficacy and safety of Sultamicillin (Ampicillin/Sulbactan) and Amoxicillin/Clavulanic acid in the treatment of upper respiratory tract infections in adults--an open-label, multicentric, randomized trial. Ferreira, JB; Kós, AO; Mocellin, M; Pignatari, SS; Piltcher, OB; Pinheiro, SD; Rapoport, PB; Sakano, E, )	0.13
"Ampicillin/Sulbactan is as safe and efficient as Amoxicillin/Clavulanate in the empiric treatment of upper respiratory infections in adults."	( Efficacy and safety of Sultamicillin (Ampicillin/Sulbactan) and Amoxicillin/Clavulanic acid in the treatment of upper respiratory tract infections in adults--an open-label, multicentric, randomized trial. Ferreira, JB; Kós, AO; Mocellin, M; Pignatari, SS; Piltcher, OB; Pinheiro, SD; Rapoport, PB; Sakano, E, )	0.13
" Adverse drug reactions (ADRs) were reported in 106 (23."	( [Efficacy and safety of potassium clavulanate/amoxicillin (CLAVAMOX) dry syrup in children with otitis media]. Asano, S; Ito, R; Kawai, M; Kudo, F; Nagata, T; Ohwaki, I; Sugita, R; Yamanaka, N, 2007)	0.34
" Both treatment regimens were well tolerated: the overall incidence of adverse events was 34/136 (25."	( Efficacy and safety of azithromycin 1 g once daily for 3 days in the treatment of community-acquired pneumonia: an open-label randomised comparison with amoxicillin-clavulanate 875/125 mg twice daily for 7 days. Cepparulo, M; Confalonieri, M; Dal Negro, R; Ligia, GP; Mos, L; Paris, R; Perna, G; Rastelli, V; Todisco, T, 2008)	0.35
" Except for this serious adverse event, both the study medications were safe and well tolerated in the study population."	( Comparative evaluation of efficacy and safety of cefotaxime-sulbactam with amoxicillin-clavulanic acid in children with lower respiratory tract infections. Chandurkar, N; Daga, S; Deshpande, A; Kulkarni, M; Pareek, A, 2008)	0.35
" It is important to review the adverse events profile related to antibiotic exposure during the clinical development of drugs that are or have been recently included in the therapeutic armamentarium."	( Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections. Aguilar, L; Coronel, P; Gimenez, MJ; Gimeno, M; Granizo, JJ; Prieto, J, 2009)	0.35
" Adverse events considered by investigators as related during antibiotic exposure were considered."	( Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections. Aguilar, L; Coronel, P; Gimenez, MJ; Gimeno, M; Granizo, JJ; Prieto, J, 2009)	0.35
"This study analysing reported adverse events from clinical trials showed an adverse events profile of cefditoren similar to those of standard antibiotics used in the treatment of respiratory tract infections."	( Safety profile of cefditoren. A pooled analysis of data from clinical trials in community-acquired respiratory tract infections. Aguilar, L; Coronel, P; Gimenez, MJ; Gimeno, M; Granizo, JJ; Prieto, J, 2009)	0.35
"Parenteral amoxycillin/clavulanate is a safe and effective antibiotic as the monotherapy for prevention of SSI following intra-abdominal surgery."	( Efficacy and safety of parenteral amoxycillin/ clavulanate for prevention of surgical site infection following abdominal surgery. Chinswangwatanakul, V; Leelaratsamee, A; Lohsiriwat, D; Lohsiriwat, V, 2009)	0.35
"5 mg given twice daily for ten days was shown to be clinically effective and safe in the treatment of community-acquired pneumonia in adult patients."	( The efficacy and safety of amoxicillin-clavulanic acid 1000/125mg twice daily extended release (XR) tablet for the treatment of bacterial community-acquired pneumonia in adults. Jain, S; Keshvani, A; Kulkarni, KP; Prabhudesai, PP, 2011)	0.37
" A similar proportion of patients (ITT population) experienced any adverse events in both treatment groups (MXF: 30."	( Efficacy and safety of IV/PO moxifloxacin and IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid in the treatment of diabetic foot infections: results of the RELIEF study. Alder, J; Arvis, P; Dryden, M; Gyssens, IC; Kujath, P; Nathwani, D; Reimnitz, P; Schaper, NC, 2013)	0.39
" Physical examination, evaluation of complaints, collection of data on adverse reactions, and bacteriological analysis of urine were performed after enrollment in the study at visit 2 (day 10 +/- 1) and 3 (day 35 +/- 2)."	( [The efficacy and safety of cefixime and amoxicillin/clavulanate in the treatment of asymptomatic bacteriuria in pregnant women: a randomized, prospective, multicenter study]. Dovgan', EV; Filippenko, NG; Gustovarova, TA; Khlybova, SV; Kozyrev, IuV; Likhikh, DG; Novoselova, AV; Rafal'skiĭ, VV, )	0.13
"Initial antibiotic treatment for acute appendicitis has been shown to be safe in adults; so far, not much is known about the safety and efficacy of this treatment in children."	( Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study. Cense, HA; Gorter, RR; Heij, HA; In 't Hof, KH; Kneepkens, CM; Offringa, M; van der Lee, JH; Wijnen, MH, 2015)	0.42
" Adverse events were defined as major complications of antibiotic treatment, such as allergic reactions, perforated appendicitis, and recurrent appendicitis."	( Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study. Cense, HA; Gorter, RR; Heij, HA; In 't Hof, KH; Kneepkens, CM; Offringa, M; van der Lee, JH; Wijnen, MH, 2015)	0.42
" None of the patients suffered from an adverse event or a recurrent appendicitis."	( Initial antibiotic treatment for acute simple appendicitis in children is safe: Short-term results from a multicenter, prospective cohort study. Cense, HA; Gorter, RR; Heij, HA; In 't Hof, KH; Kneepkens, CM; Offringa, M; van der Lee, JH; Wijnen, MH, 2015)	0.42
" Drug-related adverse events were reported in 19% of patients (5/27 patients)."	( [Efficacy and safety of clavulanic acid/amoxicillin (1: 14) dry syrup in the treatment of children with acute bacterial rhinosinusitis]. Motoyama, H; Sugita, R; Yamamoto, S; Yarita, M, 2015)	0.42
" Based on spirometry and reported side effects, inhalation of nebulized amoxicillin clavulanic acid seems to be safe and well tolerated, both in stable patients with COPD as in those experiencing a severe exacerbation."	( Safety and Tolerability of Nebulized Amoxicillin-Clavulanic Acid in Patients with COPD (STONAC 1 and STONAC 2). Assink, MD; Brusse-Keizer, MG; de Saegher, ME; Kuijvenhoven, JC; Movig, KL; Nijdam, LC; van der Palen, J; van der Valk, PD, 2016)	0.43
"In the retrospective cohort, the primary outcomes were treatment failure and adverse events 14 days after diagnosis."	( Association of Broad- vs Narrow-Spectrum Antibiotics With Treatment Failure, Adverse Events, and Quality of Life in Children With Acute Respiratory Tract Infections. Barkman, D; Bell, L; Bryan, M; Conaboy, K; Fiks, AG; Gerber, JS; Localio, AR; Odeniyi, F; Ross, RK; Szymczak, JE; Wasserman, R; Zaoutis, TE, 2017)	0.46
" Broad-spectrum treatment was associated with a higher risk of adverse events documented by the clinician (3."	( Association of Broad- vs Narrow-Spectrum Antibiotics With Treatment Failure, Adverse Events, and Quality of Life in Children With Acute Respiratory Tract Infections. Barkman, D; Bell, L; Bryan, M; Conaboy, K; Fiks, AG; Gerber, JS; Localio, AR; Odeniyi, F; Ross, RK; Szymczak, JE; Wasserman, R; Zaoutis, TE, 2017)	0.46
"Among children with acute respiratory tract infections, broad-spectrum antibiotics were not associated with better clinical or patient-centered outcomes compared with narrow-spectrum antibiotics, and were associated with higher rates of adverse events."	( Association of Broad- vs Narrow-Spectrum Antibiotics With Treatment Failure, Adverse Events, and Quality of Life in Children With Acute Respiratory Tract Infections. Barkman, D; Bell, L; Bryan, M; Conaboy, K; Fiks, AG; Gerber, JS; Localio, AR; Odeniyi, F; Ross, RK; Szymczak, JE; Wasserman, R; Zaoutis, TE, 2017)	0.46
" It is worth mentioning that central neurotoxicity is a rare side effect of metronidazole use but reversible."	( Reversible metronidazole-induced neurotoxicity after 10 weeks of therapy. AlDhaleei, W; AlMarzooqi, A; Gaber, N, 2018)	0.48
"The aims of this study were to determine the side effect frequency and serum and urine drug concentrations of amoxicillin-clavulanic acid in cats with and without azotemic chronic kidney disease (azCKD)."	( Pilot study of side effects and serum and urine concentrations of amoxicillin-clavulanic acid in azotemic and non-azotemic cats. Benson, KK; Daniels, JB; Dowers, KL; Gustafson, DL; Langston, CE; Lunghofer, PJ; Quimby, JM; Sieberg, LG, 2020)	0.56
" 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
"Resistance, prolonged therapy, and more adverse reactions made amoxicillin less preferred for treating otitis media."	( Efficacy and safety of azithromycin and amoxicillin/clavulanate for otitis media in children: a systematic review and meta-analysis of randomized controlled trials. Dawit, G; Makonnen, E; Mequanent, S, 2021)	0.62
"Pediatric acute bacterial rhinosinusitis (ABRS) is often treated with oral antibiotics, with limited insight into adverse effects (AEs) across drug classes."	( Antibiotic adverse effects in pediatric acute rhinosinusitis: Systematic review and meta-analysis. Axiotakis, LG; Caruana, FF; Gonzalez, JN; Gudis, DA; Overdevest, JB; Szeto, B, 2022)	0.72
" Adverse effects are non-negligible, but may not significantly exceed placebo."	( Antibiotic adverse effects in pediatric acute rhinosinusitis: Systematic review and meta-analysis. Axiotakis, LG; Caruana, FF; Gonzalez, JN; Gudis, DA; Overdevest, JB; Szeto, B, 2022)	0.72
"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
" Our findings support direct DPT as a safe and effective delabeling tool in children with suspected nonsevere BL-HSR."	( The Safety of the Direct Drug Provocation Test in Beta-Lactam Hypersensitivity in Children: A Systematic Review and Meta-Analysis. Chiriac, AM; Kulalert, P; Phinyo, P; Saokaew, S; Srisuwatchari, W, 2023)	0.91
" Adverse events were evaluated, including gastrointestinal symptoms, hypersensitivity and skin reactions, acute kidney injury, and secondary infections."	( Treatment Failure and Adverse Events After Amoxicillin-Clavulanate vs Amoxicillin for Pediatric Acute Sinusitis. Huybrechts, KF; Kronman, MP; Lee, SB; Oduol, T; Savage, TJ; Sreedhara, SK, 2023)	0.91

Excerpt	Reference	Relevance
" 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
" The pharmacokinetic results show that peak levels of amoxycillin and of clavulanic acid in the blood and in sputum are achieved at a later time in the patients studied than occurs in healthy volunteers."	( A pilot study of 'Augmentin' in lower respiratory tract infections: pharmacokinetic and clinical results. Brumfitt, W; Fernando, A; Hamilton-Miller, JM; Havard, CW, 1982)	0.26
" With both substances there was no significant difference between the pharmacokinetic parameters after administration alone and in combination."	( Pharmacokinetic studies of amoxicillin, potassium clavulanate and their combination. Höffken, G; Koeppe, P; Lode, H; Witkowski, G, 1982)	0.26
"An in vitro pharmacodynamic model was used to simulate the in vivo pharmacokinetics of clarithromycin and 14-hydroxyclarithromycin in order to generate time-kill curves for three clinical isolates of Haemophilus influenzae (isolates 2019, 91-183, and 1746)."	( Evaluation of antimicrobial activities of clarithromycin and 14-hydroxyclarithromycin against three strains of Haemophilus influenzae by using an in vitro pharmacodynamic model. Larsson, AJ; Rotschafer, JC; Walker, KJ; Zabinski, RA, 1994)	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
" Pharmacokinetic variables were obtained from the literature, and serum concentration-time profiles were simulated for a 25-kg child taking pediatric dosages commonly administered to treat otitis media."	( In vitro activity and pharmacodynamics of oral beta-lactam antibiotics against Streptococcus pneumoniae from southeast Missouri. Kays, MB; Miles, DO; Wood, KK, 1999)	0.3
" We also determined the serum levels of the antimicrobial agent in the mice, and correlated the pharmacodynamic parameters (Cmax/MIC, AUC/MIC and T>MIC) with the survival rate to establish the best predictor of efficacy."	( [Pharmacodynamic basis for the use of amoxicillin-clavulanic acid in respiratory infections due to Streptococcus pneumoniae: In vitro studies in an experimental model]. Amores, R; Fuentes, F; García, Y; Gómez-Lus, ML; Valero, E, 2000)	0.31
"2 g of clavulanate in combination during the first 12 hrs posttrauma in patients, and at the start of the pharmacokinetic study in volunteers."	( Co-amoxiclav pharmacokinetics during posttraumatic hemorrhagic shock. Edouard, A; Incagnoli, P; Louchahi, K; Mimoz, O; Petitjean, O; Schaeffer, V; Tod, M, 2001)	0.31
" The interindividual variabilities for all the amoxicillin pharmacokinetic parameters were higher in patients."	( Co-amoxiclav pharmacokinetics during posttraumatic hemorrhagic shock. Edouard, A; Incagnoli, P; Louchahi, K; Mimoz, O; Petitjean, O; Schaeffer, V; Tod, M, 2001)	0.31
" There were no significant differences in terminal elimination half-life between days 1 and 7 (9."	( Single- and multiple-dose pharmacokinetics of linezolid and co-amoxiclav in healthy human volunteers. Borner, K; Burkhardt, O; Köppe, P; Lode, H; Nord, CE; Pletz, MW; von der Höh, N, 2002)	0.31
" The pharmacokinetic parameters were determined for the serum samples and compared to the published data for humans (2."	( Ex vivo pharmacodynamics of amoxicillin-clavulanate against beta-lactamase-producing Escherichia coli in a yucatan miniature pig model that mimics human pharmacokinetics. Bronner, S; Dhoyen, N; Elkhaïli, H; Jehl, F; Levêque, D; Monteil, H; Murbach, V; Peter, JD; Salmon, Y; Woodnutt, G, 2002)	0.31
" Pharmacokinetic analysis revealed good oral bioavailability and moderate clearance and volume of distribution."	( Oral anti-pneumococcal activity and pharmacokinetic profiling of a novel peptide deformylase inhibitor. Beckett, RP; Chen, H; Clements, J; Difuntorum, S; Garcia, M; Gross, M; Hoch, U; Johnson, KW; Lofland, D; Ramanathan-Girish, S; Taylor, S; Thomas, W, 2004)	0.32
", were studied in an in vitro pharmacokinetic model of infection."	( Antibacterial effects of amoxicillin-clavulanate against Streptococcus pneumoniae and Haemophilus influenzae strains for which MICs are high, in an in vitro pharmacokinetic model. Bowker, KE; MacGowan, AP; Noel, AR; Rogers, CA, 2004)	0.32
"A complete a literature search was undertaken to establish the MIC90 values of the five microorganisms most frequently isolated in odontogenic infections and the pharmacokinetic parameters of 13 antibiotics used in these infections."	( [Pharmacokinetic/pharmacodynamic analysis of antibiotic therapy in dentistry and stomatology]. Ardanza-Trevijano, B; Canut, A; Isla, A; Labora, A; Pedraz, JL; Rodríguez-Gascón, A; Solinís, MA, 2005)	0.33
"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
"To explore the urine bactericidal activity of co-amoxiclav and norfloxacin against Escherichia coli in an in vitro pharmacodynamic model simulating the human urinary concentrations observed after administration of a single oral dose of 2000/125 mg sustained-release co-amoxiclav and 400 mg norfloxacin."	( Urine bactericidal activity against resistant Escherichia coli in an in vitro pharmacodynamic model simulating urine concentrations obtained after 2000/125 mg sustained-release co-amoxiclav and 400 mg norfloxacin administration. Aguilar, L; Alou, L; Cafini, F; Giménez, MJ; Prieto, J; Relaño, MT; Sevillano, D; Valero, E, 2006)	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
" Pharmacokinetic (PK) parameters for amoxicillin and clavulanic acid of the new therapeutic systems: AUCt, AUCi, (AUCt/AUCi), Cmax, Tmax, kel, T(1/2) and additionally for amoxicillin T(4) and T(2) were calculated from the plasma levels."	( A new amoxicillin/clavulanate therapeutic system: preparation, in vitro and pharmacokinetic evaluation. Kerč, J; Opara, J, 2007)	0.34
" From the pharmacodynamic perspective, BSAC breakpoints seem more adequate to define or detect BLNAR strains."	( Are beta-lactam breakpoints adequate to define non-susceptibility for all Haemophilus influenzae resistance phenotypes from a pharmacodynamic point of view? Aguilar, L; Alou, L; Coronel, P; Echeverría, O; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2007)	0.34
"During the last 10-15 years understanding of relationships between pharmacokinetic (PK) and pharmacodynamic (PD) parameters and bacteriological and clinical outcomes has expanded allowing correlation between in vitro potency and in vivo efficacy."	( Combating resistance: application of the emerging science of pharmacokinetics and pharmacodynamics. Jacobs, MR, 2007)	0.34
"Double tympanocentesis studies of children with acute otitis media, carried out over an 11-year period, were used to confirm that pharmacokinetic (PK) and pharmacodynamic (PD) parameters can be used as predictors of the bacteriological and clinical efficacy of antimicrobial agents."	( The use of pharmacokinetic/pharmacodynamic principles to predict clinical outcome in paediatric acute otitis media. Dagan, R, 2007)	0.34
"The objective of this study was to evaluate the efficacy of the most commonly used antimicrobial treatments in odontogenic infections in children and adolescents on the basis of pharmacokinetic/ pharmacodynamic (PK/PD) criteria."	( [Antibiotic therapy in odontogenic infections in children and adolescents: pharmacokinetic/pharmacodynamic analysis]. Beltrí-Orta, P; Canut, A; Isla, A; Labora, A; Pedraz, JL; Planells, P; Rodríguez-Gascón, A; Salmerón-Escobar, JI, 2008)	0.35
"Unbound drug plasma concentration-time curves were simulated with mean population pharmacokinetic parameters of amoxicillin, co-amoxiclav, cefuroxime axetil, spiramycin, clindamycin, azithromycin, and metronidazole."	( [Antibiotic therapy in odontogenic infections in children and adolescents: pharmacokinetic/pharmacodynamic analysis]. Beltrí-Orta, P; Canut, A; Isla, A; Labora, A; Pedraz, JL; Planells, P; Rodríguez-Gascón, A; Salmerón-Escobar, JI, 2008)	0.35
" A computerized pharmacodynamic model simulating free antibiotic concentrations (calculated considering reported percentages of protein binding) of 400 mg twice-daily cefditoren, 500 mg twice-daily cefuroxime and 875/125 mg three times daily amoxicillin/clavulanic acid was used to explore antibacterial activity against initial mixed inocula with 25% of each strain."	( Influence of different resistance traits on the competitive growth of Haemophilus influenzae in antibiotic-free medium and selection of resistant populations by different {beta}-lactams: an in vitro pharmacodynamic approach. Aguilar, L; Alou, L; Cafini, F; Coronel, P; Giménez, MJ; González, N; Prieto, J; Sevillano, D; Torrico, M, 2009)	0.35
" The aim of this work was to evaluate the usefulness of amoxicillin, amoxicillin/clavulanate and ceftriaxone for the empirical treatment of acute otitis media, looking at the pharmacokinetic variability and the antimicrobial susceptibility of paediatric strains of the two main pathogens responsible for AOM in Spain, Streptococcus pneumoniae and Haemophilus influenzae."	( Pharmacokinetic/pharmacodynamic evaluation of amoxicillin, amoxicillin/clavulanate and ceftriaxone in the treatment of paediatric acute otitis media in Spain. Canut, A; Gascón, AR; Isla, A; Labora, A; Martín-Herrero, JE; Pedraz, JL; Trocóniz, IF, 2011)	0.37
"3%, area under the concentration curve (AUC0-24) +24."	( Effect of Lactobacillus sporogenes on oral isoflavones bioavailability: single dose pharmacokinetic study in menopausal women. Benvenuti, C; Setnikar, I, 2011)	0.37
" The pharmacokinetic parameters were calculated by DAS2."	( [Pharmacokinetics study of amoxicillin sodium clavulanate potassium (10:1) injection in healthy volunteers]. Liang, MZ; Miao, J; Nan, F; Qin, YP; Shen, Q; Wang, Y; Yu, Q; Zheng, L, 2013)	0.39
" To avoid the biases caused by compartment model fitting, the pharmacokinetic parameters were statistical moment parameters of non-compartment model."	( [Pharmacokinetics study of amoxicillin sodium clavulanate potassium (10:1) injection in healthy volunteers]. Liang, MZ; Miao, J; Nan, F; Qin, YP; Shen, Q; Wang, Y; Yu, Q; Zheng, L, 2013)	0.39
"In this observational pharmacokinetic study, multiple blood samples were taken over one dosing interval of intravenous amoxicillin/clavulanic acid (1000/200 mg)."	( Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. Carlier, M; De Waele, JJ; Lipman, J; Noë, M; Roberts, JA; Stove, V; Verstraete, AG, 2013)	0.39
" Dosing simulations for amoxicillin supported the use of standard dosing regimens (30 min infusion of 1 g four-times daily or 2 g three-times daily) for most patients when using a target MIC of 8 mg/L and a pharmacodynamic target of 50% fT>MIC, except for those with a creatinine clearance >190 mL/min."	( Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. Carlier, M; De Waele, JJ; Lipman, J; Noë, M; Roberts, JA; Stove, V; Verstraete, AG, 2013)	0.39
"Although vast pharmacokinetic variability exists for both amoxicillin and clavulanic acid in intensive care unit patients, current dosing regiments are appropriate for most patients, except those with very high creatinine clearance."	( Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. Carlier, M; De Waele, JJ; Lipman, J; Noë, M; Roberts, JA; Stove, V; Verstraete, AG, 2013)	0.39
" Pharmacokinetic parameters were calculated using noncompartmental methods."	( Effects of amoxicillin/clavulanic acid on the pharmacokinetics of valproic acid. Huh, W; Jung, JA; Kim, JR; Ko, JW; Lee, SY; Yoo, HM, 2015)	0.42
" Population pharmacokinetic analysis was conducted, and the clinical outcome was documented."	( Augmented renal clearance implies a need for increased amoxicillin-clavulanic acid dosing in critically ill children. Barker, CI; Carlier, M; De Cock, PA; de Jaeger, A; De Paepe, P; Delanghe, JR; Dhont, E; Robays, H; Standing, JF; Verstraete, AG, 2015)	0.42
" We analysed the concentration-time profiles using a non-compartmental pharmacokinetic method (PKSolver) and a population pharmacokinetic method (NONMEM)."	( Non-linear absorption pharmacokinetics of amoxicillin: consequences for dosing regimens and clinical breakpoints. de Velde, F; de Winter, BC; Koch, BC; Mouton, JW; van Gelder, T, 2016)	0.43
"AUC0-24 and Cmax increased non-linearly with dose."	( Non-linear absorption pharmacokinetics of amoxicillin: consequences for dosing regimens and clinical breakpoints. de Velde, F; de Winter, BC; Koch, BC; Mouton, JW; van Gelder, T, 2016)	0.43
"To calculate the clavulanic acid exposure of oral amoxicillin/clavulanic acid dosing regimens, to investigate variability using a population pharmacokinetic model and to explore target attainment using Monte Carlo simulations."	( Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis. De Velde, F; De Winter, BCM; Koch, BCP; Mouton, JW; Van Gelder, T, 2018)	0.48
" Concentrations were analysed using non-compartmental (WinNonLin) and population pharmacokinetic (NONMEM) methods."	( Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis. De Velde, F; De Winter, BCM; Koch, BCP; Mouton, JW; Van Gelder, T, 2018)	0.48
" Pharmacokinetic parameters could not be calculated."	( Pharmacokinetics and Drug Residue in Eggs After Multiple-Day Oral Dosing of Amoxicillin-Clavulanic Acid in Domestic Chickens. Bailey, J; Cox, SK; Davis, R; Fortner, C; Gerhardt, L; Shannon, L; Souza, MJ, 2020)	0.56
" 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
"The pharmacokinetic behaviours of amoxicillin (AMX) and clavulanic acid (CA) in swine were studied after either an intravenous or oral administration of AMX (10 mg/kg) and CA (2."	( The bioavailability and pharmacokinetics of an amoxicillin-clavulanic acid granular combination after intravenous and oral administration in swine. Cao, X; Sun, P; Wang, J; Xiao, H; Zhang, S; Zhao, T, 2021)	0.62

Excerpt	Reference	Relevance
" The absence of the outer membrane proteins, OmpF and OmpC, did not significantly affect susceptibility to the combinations per se but when combined with the presence of beta-lactamase high MICs were observed."	( Factors determining resistance to beta-lactam combined with beta-lactamase inhibitors in Escherichia coli. Baquero, F; Martínez, JL; Pérez-Díaz, JC; Reguera, JA, 1991)	0.28
"Assess the supplementary therapeutic benefit provided by fenspiride administered in combination with antibiotics in COPD patients presenting an episode of bronchial infection."	( [Evaluation and symptomatic treatment of surinfectious exacerbations of COPD: preliminary study of antibiotic treatment combined with fenspiride (Pneumorel 80mg) versus placebo]. Benezet, O; Dansin, E; Lirsac, B; Nouvet, G; Stach, B; Voisin, C, 2000)	0.31
"The efficacy of cationic peptides combined with betalactams was investigated in a peritonitis rat model."	( Cationic peptides combined with betalactams reduce mortality from peritonitis in experimental rat model. Cirioni, O; Ghiselli, R; Giacometti, A; Mocchegiani, F; Saba, V; Scalise, G; Viticchi, C, 2002)	0.31
"A 58-year-old Hawaiian/Asian/European woman developed an elevated INR and microscopic hematuria as a result of a drug-drug interaction between warfarin and AM/CL."	( Warfarin and amoxicillin/clavulanate drug interaction. Cuni, LJ; Davydov, L; Yermolnik, M, 2003)	0.32
"Predominant groups of bacteria from a human fecal flora-associated mouse model challenged with amoxicillin-clavulanic acid were quantified with fluorescence in situ hybridization combined with flow cytometry using specific 16S rRNA targeted oligonucleotide probes."	( Effect of amoxicillin-clavulanic acid on human fecal flora in a gnotobiotic mouse model assessed with fluorescence hybridization using group-specific 16S rRNA probes in combination with flow cytometry. Barc, MC; Boureau, H; Bourlioux, F; Charrin-Sarnel, C; Collignon, A; Doré, J; Janoir, C; Rigottier-Gois, L, 2004)	0.32
"The authors describe the diagnostic problems and difficulties of treatment of Warthin's tumor combined with actinomycosis."	( [Parotid gland Warthin's tumor combined with actinomycosis]. Barabás, J; Bogdán, S; Decker, I; Huszár, T; Lukáts, O; Suba, Z; Szabó, G, 2006)	0.33
" Therefore, the selection of the antibiotic for combination with G-CSF in sepsis treatment should be guided not only by the bacteria to be eliminated, but also by the effects on antimicrobial functions of PMNs and the cytokine response."	( Differential effects of antibiotics in combination with G-CSF on survival and polymorphonuclear granulocyte cell functions in septic rats. Bauhofer, A; Huttel, M; Lorenz, W; Sessler, DI; Torossian, A, 2008)	0.35
" The animals, which received thalidomide alone orally or in combination with augmentin, 30 min prior to bacterial instillation into the lungs via intranasal route, showed significant (P<0."	( Anti-inflammatory effect of thalidomide alone or in combination with augmentin in Klebsiella pneumoniae B5055 induced acute lung infection in BALB/c mice. Chhibber, S; Kumar, V, 2008)	0.35
"A pharmacokinetic-pharmacodynamic (PK-PD) drug-drug interaction between acenocoumarol and amoxicillin + clavulanic acid antibiotic was assessed in eight healthy volunteers, using a population PK-PD) model."	( Investigation of PK-PD drug-drug interaction between acenocoumarol and amoxicillin plus clavulanic acid. Basset, T; Delavenne, X; Demasles, S; Girard, P; Laporte, S; Mallouk, N; Mismetti, P; Tod, M, 2009)	0.35
" The animals that received curcumin alone orally or in combination with augmentin, 15 days prior to bacterial instillation into the lungs via the intranasal route, showed a significant (P <0."	( Curcumin alone and in combination with augmentin protects against pulmonary inflammation and acute lung injury generated during Klebsiella pneumoniae B5055-induced lung infection in BALB/c mice. Bansal, S; Chhibber, S, 2010)	0.36
" aureus (four MRSA and two GISA) and four strains of enterococci (two Enterococcus faecalis and two Enterococcus faecium) were serially exposed in broth to two-fold stepwise increasing concentrations of daptomycin alone or in combination with a fixed concentration [0."	( In vitro prevention of the emergence of daptomycin resistance in Staphylococcus aureus and enterococci following combination with amoxicillin/clavulanic acid or ampicillin. Entenza, JM; Giddey, M; Moreillon, P; Vouillamoz, J, 2010)	0.36
" High doses of amoxicillin/clavulanate were associated with a higher risk of over-anticoagulation when combined with warfarin than were normal doses."	( Warfarin-drug interactions: An emphasis on influence of polypharmacy and high doses of amoxicillin/clavulanate. Abdel-Aziz, MI; Ali, MA; Elfaham, TH; Hassan, AK, 2016)	0.43

Excerpt	Reference	Relevance
" 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
" Both amoxicillin and clavulanic are well absorbed after oral administration, reach peak serum levels in 40-120 min and have similar half-lives of 45 to 90 min."	( Amoxicillin and potassium clavulanate: an antibiotic combination. Mechanism of action, pharmacokinetics, antimicrobial spectrum, clinical efficacy and adverse effects. Rubin, RH; Tolkoff-Rubin, NE; Weber, DJ, )	0.13
" 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
" The absolute bioavailability of amoxicillin (AUCoral/AUCi."	( Pharmacokinetic studies of amoxicillin, potassium clavulanate and their combination. Höffken, G; Koeppe, P; Lode, H; Witkowski, G, 1982)	0.26
" The relative bioavailability of T to R were 96."	( Bioequivalence of clavulanate potassium and amoxicillin (1:7) dispersible tablets in healthy volunteers. Dai, Z; Han, Y; Hou, S; Hu, G; Long, L; Wu, L, 2002)	0.31
" Pharmacokinetic analysis revealed good oral bioavailability and moderate clearance and volume of distribution."	( Oral anti-pneumococcal activity and pharmacokinetic profiling of a novel peptide deformylase inhibitor. Beckett, RP; Chen, H; Clements, J; Difuntorum, S; Garcia, M; Gross, M; Hoch, U; Johnson, KW; Lofland, D; Ramanathan-Girish, S; Taylor, S; Thomas, W, 2004)	0.32
" The data showed that the bioavailability characteristics of the test tablet, taken intact or in dispersed form, and the reference tablets were very similar."	( Amoxicillin/clavulanic acid (875/125): bioequivalence of a novel Solutab tablet and rationale for a twice-daily dosing regimen. Bertola, MA; Kuipers, M; Rayer, B; Sourgens, H; Verschoor, JS, 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
"A new peroral amoxicillin/clavulanate therapeutic system composed of immediate release tablet and controlled release floating capsule was developed and evaluated by in vivo bioavailability study."	( A new amoxicillin/clavulanate therapeutic system: preparation, in vitro and pharmacokinetic evaluation. Kerč, J; Opara, J, 2007)	0.34
" For "selective intestinal decontamination", poorly absorbed oral norfloxacin is the preferred schedule."	( [Bacterial infections in liver cirrhosis]. Farkas, A; Papp, M; Tornai, I; Udvardy, M, 2007)	0.34
" The simultaneous prescription of nonsteroidal antiinflammatory drugs (NSAIDs) can modify the bioavailability of the antibiotic."	( Antibiotic use in dental practice. A review. Bagan, JV; Carbonell Pastor, E; Poveda Roda, R; Sanchis Bielsa, JM, 2007)	0.34
" The localization data showed that the reduced bioavailability of amoxicillin under fasting conditions is due to early gastric emptying in combination with poor absorption from deeper parts of the small intestine."	( Bioavailability of amoxicillin and clavulanic acid from extended release tablets depends on intragastric tablet deposition and gastric emptying. Friedrich, C; Horkovics-Kovats, S; Kinzig, M; Kosch, O; Mönnikes, H; Raneburger, J; Schmidtmann, M; Schwarz, F; Siegmund, W; Sörgel, F; Trahms, L; Wedemeyer, RS; Weitschies, W, 2008)	0.35
"To verify the single dose bioavailability of two oral formulations of soy isoflavones, with and without lactobacilli, in menopausal women in antibiotic therapy."	( Effect of Lactobacillus sporogenes on oral isoflavones bioavailability: single dose pharmacokinetic study in menopausal women. Benvenuti, C; Setnikar, I, 2011)	0.37
"The amoxicillin absorption rate appears to be saturable."	( Non-linear absorption pharmacokinetics of amoxicillin: consequences for dosing regimens and clinical breakpoints. de Velde, F; de Winter, BC; Koch, BC; Mouton, JW; van Gelder, T, 2016)	0.43
" Bioavailability (fixed at 1 at 8:00 h, between-occasion variability 28."	( Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis. De Velde, F; De Winter, BCM; Koch, BCP; Mouton, JW; Van Gelder, T, 2018)	0.48
" Bioavailability and absorption rate decrease over the day."	( Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis. De Velde, F; De Winter, BCM; Koch, BCP; Mouton, JW; Van Gelder, T, 2018)	0.48
" This pilot study was conducted to determine preliminary pharmacokinetic parameters and relative oral bioavailability of a human generic and veterinary proprietary 4:1 amoxicillin-clavulanic acid formulation in healthy dogs to evaluate whether drug exposure was similar and to determine if further comparative investigation is warranted."	( Relative Oral Bioavailability of Two Amoxicillin-Clavulanic Acid Formulations in Healthy Dogs: A Pilot Study. Berger, DJ; Coetzee, JF; LeVine, DN; Lin, Z; Mochel, JP; Moczarnik, J; Noxon, JO, )	0.13
" 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
" The mean oral bioavailability of AMX and CA was 23."	( The bioavailability and pharmacokinetics of an amoxicillin-clavulanic acid granular combination after intravenous and oral administration in swine. Cao, X; Sun, P; Wang, J; Xiao, H; Zhang, S; Zhao, T, 2021)	0.62
"Oral third-generation cephalosporins (3GCs) are not recommended for use owing to their low bioavailability and the risk of emergence of resistant microorganisms with overuse."	( Reduction strategies for inpatient oral third-generation cephalosporins at a cancer center: An interrupted time-series analysis. Akazawa, N; Ishibana, Y; Itoh, N; Kawabata, T; Kawamura, D; Kodama, EN; Murakami, H; Ohmagari, N, 2023)	0.91

Excerpt	Relevance	Reference
" Study patients seen at the hospital outpatient clinics were given the drug in a daily dosage of 80 mg in three (83% of cases) or four (15%) divided doses for 6 to 10 days; 28% of patients were also given an antiinflammatory agent."	( [Efficacy and tolerance of a new formulation of amoxicillin 100 mg--clavulanic acid 12.5 mg in acute otitis in infants]. Astruc, J, 1992)	0.28
" Based on the efficacy results from this study, the lower gastrointestinal side effects and the convenience of twice-a-day dosing, we believe that cefprozil in a dosage of 30 mg/kg/day divided every 12 hours represents a potential alternative for the treatment of acute otitis media with effusion in children."	( Comparative trial of cefprozil vs. amoxicillin clavulanate potassium in the treatment of children with acute otitis media with effusion. Arguedas, AG; Blumer, JL; Hains, CS; Stutman, HR; Zaleska, M, 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
"5 or 125 mg) 3-times daily, dosage and duration of treatment being determined by the severity of the condition."	( An open, comparative evaluation of amoxycillin and amoxycillin plus clavulanic acid ('Augmentin') in the treatment of bacterial pneumonia in children. Ifere, OA; Jibril, HB; Odumah, DU, 1989)	0.28
" Adult dosage was usually 2 g per day as two divided doses over 8 to 10 days."	( [Results of a multicenter study of an amoxicillin-clavulanic acid combination in sinusitis in children and adults]. Bourdinière, J; Le Clech, G, 1987)	0.27
" was 1 X 10(6) approximately 9 X 10(6) cells/g feces on average before commencement of dosage and it increased by 2 logarithms 3 days after initiation of administration but there was no consistent change in the Klebsiella sp."	( [Effect of BRL 25000 (clavulanic acid-amoxicillin) on bacterial flora in human feces]. Fujimoto, T; Ishimoto, K; Koga, T; Kuda, N; Motohiro, T; Nishiyama, T; Sakata, Y; Shimada, Y; Tanaka, K; Tomita, N, 1985)	0.27
" In a cross over study, six animals were randomly allocated to treatment with either amoxycillin alone (10 mg/kg, dosed twice daily) or a formulation of clavulanate-potentiated amoxycillin (12."	( Efficacy of clavulanate-potentiated amoxycillin in experimental and clinical skin infections. Bywater, RJ; Hewett, GR; Marshall, AB; West, B, 1985)	0.27
" An average daily dosage of 45."	( [Experimental and clinical trials of BRL 25000 (clavulanic acid-amoxicillin) granules in the field of pediatrics]. Harada, M; Iriki, T; Ishimoto, K; Koga, T; Motohiro, T; Nishiyama, T; Shimada, Y; Tanaka, K; Tominaga, K; Tomita, N, 1985)	0.27
" The daily dosage of BRL 25000 ranged from 23."	( [Clinical trials of BRL 25000 (clavulanic acid-amoxicillin) granules on skin and soft tissue infections in the field of pediatrics]. Harada, M; Iriki, T; Ishimoto, K; Koga, T; Motohiro, T; Nishiyama, T; Shimada, Y; Tanaka, K; Tominaga, K; Tomita, N, 1985)	0.27
" Each drug was given in a daily dosage of approximately 40 mg/kg in three divided doses for ten days."	( Comparative treatment trial of augmentin versus cefaclor for acute otitis media with effusion. Kusmiesz, H; Nelson, JD; Odio, CM; Shelton, S, 1985)	0.27
"The chemistry, microbiology, pharmacokinetics, therapeutic use, adverse effects, and dosage of amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic combination, are reviewed."	( Amoxicillin-potassium clavulanate, a beta-lactamase-resistant antibiotic combination. Gurwith, MJ; Stein, GE, )	0.13
"The combination of amoxicillin and potassium clavulanate will soon be marketed in 2:1 and 4:1 fixed ratio dosage forms."	( Amoxicillin and potassium clavulanate: an antibiotic combination. Mechanism of action, pharmacokinetics, antimicrobial spectrum, clinical efficacy and adverse effects. Rubin, RH; Tolkoff-Rubin, NE; Weber, DJ, )	0.13
" 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
" Compliance with dosing was assessable with weight of drug consumed in 127 patients in each treatment group."	( Multicenter controlled trial comparing ceftibuten with amoxicillin/clavulanate in the empiric treatment of acute otitis media. Members of the Ceftibuten Otitis Media United States Study Group. Mccarty, JM; Mclinn, SE; Perrotta, R; Pichichero, ME; Reidenberg, BE, 1995)	0.29
" Roxithromycin appears to be a more appropriate choice than amoxycillin/clavulanic acid for the treatment of LRTI in the community given its more appropriate in vitro spectrum, efficacy against most common and atypical pathogens, greater cost-effectiveness, more convenient dosage regimen (b."	( Roxithromycin 150 mg b.i.d. versus amoxycillin 500 mg/clavulanic acid 125 mg t.i.d. for the treatment of lower respiratory tract infections in general practice. Cooper, BC; Cursons, RT; Garrett, JE; Karalus, NC; Kostalas, GN; Lang, SD; Leng, RA; Ryan, CJ, 1995)	0.29
" The superior safety profile, a twice daily dosage regimen, suggests that ciprofloxacin may be a useful therapeutic alternative for the treatment of chronic sinusitis."	( A double-blind comparison of ciprofloxacin and amoxycillin/clavulanic acid in the treatment of chronic sinusitis. Beauvillain, C; Berche, P; Bordure, P; Legent, F, 1994)	0.29
" Mice were dosed orally, commencing at 7 days after infection, with minocycline, doxycycline, or amoxicillin-clavulanate."	( Characteristics of murine model of genital infection with Chlamydia trachomatis and effects of therapy with tetracyclines, amoxicillin-clavulanic acid, or azithromycin. Beale, AS; Upshon, PA, 1994)	0.29
" In two trials, 891 pediatric patients were enrolled to either cefprozil or amoxicillin-clavulanate dosage regimens."	( Multi-investigator evaluation of the efficacy and safety of cefprozil, amoxicillin-clavulanate, cefixime and cefaclor in the treatment of acute otitis media. Kafetzis, DA, 1994)	0.29
" The concentration of amoxycillin and clavulanic acid was determined in bronchial mucosal biopsy samples obtained at bronchoscopy following five different dosing regimens."	( Penetration of amoxycillin/clavulanic acid into bronchial mucosa with different dosing regimens. Douglas, JG; Friend, JA; Golder, D; Gould, IM; Harvey, G; Legge, JS; Reid, TM; Watt, SJ, 1994)	0.29
"Concentrations of both clavulanic acid and amoxycillin in bronchial mucosa were dose related and were well above the MIC90 of co-amoxiclav for the common bacterial respiratory pathogens including Haemophilus influenzae, Micrococcus catarrhalis and Streptococcus pneumoniae for all dosing regimens."	( Penetration of amoxycillin/clavulanic acid into bronchial mucosa with different dosing regimens. Douglas, JG; Friend, JA; Golder, D; Gould, IM; Harvey, G; Legge, JS; Reid, TM; Watt, SJ, 1994)	0.29
"Treatment with 3 days or 10 days of antibiotics at a dosage of 20 mg/kg per day of amoxicillin and 5 mg/kg per day of clavulanate potassium in three divided doses."	( The role of bacterial adhesins in the outcome of childhood urinary tract infections. Adams, KS; Arbeit, RD; Fattlar, DC; Johnson, CE; Maslow, JN, 1993)	0.29
"160 children with an average age of 9 years (range 6-15) affected by acute bacterial tonsillitis, were selected and assigned, following an open, parallel group design to: a) brodimoprim at the dose of 10 mg/kg on the first day, in single administration, and of 5 mg/kg on the following days; b) cotrimoxazole suspension, at the dosage of 6 mg of trimethoprim/kg/day, in two daily administrations; c) amoxicillin with clavulanic acid suspension (amoxi-clavulanate) 50 mg/kg every 12 hours."	( Efficacy and tolerability of brodimoprim in pharyngotonsillitis in children. Dallari, S; Galetti, G, 1993)	0.29
" In this study the pharmacokinetic profiles of different dosing regimens utilizing these drugs during reconstructive vascular procedures are presented."	( Optimizing antimicrobial prophylaxis in reconstructive vascular surgery. Agema, A; Degener, JE; Dijkstra, PK; Sikkema, B; van der Goot, L; van der Meer, AL; Voesten, HG, 1993)	0.29
" Azithromycin (10 mg/kg/day) was administered as a single dose for three days and co-amoxiclav was given tid for ten days at a dosage according to the manufacturer's instructions for the country."	( Comparison of azithromycin and co-amoxiclav in the treatment of otitis media in children. Daniel, RR, 1993)	0.29
" The dosage schedule for azithromycin was 10 mg/kg/day, in a single daily dose, administered for three days."	( Multicentre evaluation of azithromycin in comparison with co-amoxiclav for the treatment of acute otitis media in children. Schaad, UB, 1993)	0.29
" Fleroxacin was given at a dosage of 400 mg once daily, and AMX/CP was given at a dosage of 500 mg/125 mg three times a day."	( Open trial of oral fleroxacin versus amoxicillin/clavulanate in the treatment of infections of skin and soft tissue. Powers, RD, 1993)	0.29
"01 mg/L) the minimum dosage tested achieving significant cure was 2 mg/kg for amoxycillin, co-amoxiclav and cefotaxime."	( Correlation of in-vitro activity and pharmacokinetic parameters with in-vivo effect of amoxycillin, co-amoxiclav and cefotaxime in a murine model of pneumococcal pneumonia. Nieto, E; Parra, A; Ponte, C; Soriano, F, 1996)	0.29
" No difference was found between twice and thrice daily dosing regimens in the overall percentage of prescribed doses given."	( Owner compliance with short term antimicrobial medication in dogs. Barter, LS; Maddison, JE; Watson, AD, 1996)	0.29
" Two randomized, investigator-blind, multicenter trials (one in the United States and one in Europe) compared two dosage regimens of cefdinir (600 mg once a day for 10 days and 300 mg twice a day for 10 days) to amoxicillin-clavulanate (A-C) (500 mg three times a day for 10 days) for adult and adolescent patients with ACABS."	( Comparative effectiveness and safety of cefdinir and amoxicillin-clavulanate in treatment of acute community-acquired bacterial sinusitis. Cefdinir Sinusitis Study Group. Gwaltney, JM; Keyserling, C; Leigh, A; Rivas, P; Savolainen, S; Scheld, WM; Schenk, P; Sydnor, A; Tack, KJ, 1997)	0.3
" This method is convenient and reproducible for analyses of these two components in different dosage forms."	( Simultaneous determination of amoxycillin and clavulanic acid in pharmaceutical products by HPLC with beta-cyclodextrin stationary phase. Tsou, TL; Wang, TM; Wu, JR; Young, CD, 1997)	0.3
" The efficacy and safety of azithromycin suspension (10 mg/kg), dosed orally once daily for 3 days, was compared with that of co-amoxiclav (10 mg/kg in a 4:1 ratio), dosed orally three times daily for 5-10 days."	( An open, multicentre, comparative study of the efficacy and safety of azithromycin and co-amoxiclav in the treatment of upper and lower respiratory tract infections in children. The Paediatric Azithromycin Study Group. Lauvau, DV; Verbist, L, )	0.13
" Azithromycin was as effective, and as well tolerated as co-amoxiclav, and its shorter simpler dosing regime may offer advantages in compliance and cost."	( A comparison of the efficacy, tolerability and safety of azithromycin and co-amoxiclav in the treatment of sinusitis in adults. Clement, PA; de Gandt, JB, )	0.13
" Each cat underwent a bacteriological examination before treatment (day 0) and received either marbofloxacin, at a dosage of 2 mg/kg once daily for five days, or amoxycillin-clavulanic acid (ACA) at a dosage of 12."	( Comparative field evaluation of marbofloxacin tablets in the treatment of feline upper respiratory infections. Dossin, O; Gruet, P; Thomas, E, 1998)	0.3
" These studies demonstrate that a reduction of 1 log10 or greater in CFU/thigh at 24 h is consistently observed when amoxicillin levels exceed the MIC for 25 to 30% of the dosing interval."	( In vivo activities of amoxicillin and amoxicillin-clavulanate against Streptococcus pneumoniae: application to breakpoint determinations. Andes, D; Craig, WA, 1998)	0.3
" As T>MIC increased, the response, in terms of decreased bacterial load, improved and at T>MICs of greater than 35 to 40% of the dosing interval, bacteriological cure was maximal."	( Two pharmacodynamic models for assessing the efficacy of amoxicillin-clavulanate against experimental respiratory tract infections caused by strains of Streptococcus pneumoniae. Berry, V; Woodnutt, G, 1999)	0.3
"4-mg/kg/day equivalent dosage for strains for which amoxicillin MICs were 2 or 4 microg/ml."	( Efficacy of high-dose amoxicillin-clavulanate against experimental respiratory tract infections caused by strains of Streptococcus pneumoniae. Berry, V; Woodnutt, G, 1999)	0.3
" A significantly simpler dosage regimen and faster clinical effect were the advantages of azithromycin."	( Azithromycin versus amoxicillin/clavulanate in the treatment of acute sinusitis. Culig, J; Klapan, I; Matrapazovski, M; Oresković, K; Radosević, S, )	0.13
" ceftriaxone 1 g once daily is as effective as standard therapy in the treatment of LRTI and that its use reduces treatment costs, in view of the multiple daily dosing regimens of most standard therapies."	( A randomised, multicentre study of ceftriaxone versus standard therapy in the treatment of lower respiratory tract infections. Bunnik, MC; de Klerk, GJ; Dofferhof, AS; Geraedts, WH; Hensing, CA; Hoepelman, AI; Jaspers, CA; Lobatto, S; Melis, JH; Van Den Berg, J; van Steijn, JH; van Veldhuizen, WC, 1999)	0.3
" The average time above MIC (T > MIC) was calculated as percentage of the dosing interval using free concentrations and the MIC for each individual isolate."	( In vitro activity and pharmacodynamics of oral beta-lactam antibiotics against Streptococcus pneumoniae from southeast Missouri. Kays, MB; Miles, DO; Wood, KK, 1999)	0.3
" The postantibiotic effect would prolong the effect of the antibiotic in the dosing interval."	( [Pharmacodynamic basis for the use of amoxicillin-clavulanic acid in respiratory infections due to Streptococcus pneumoniae: In vitro studies in an experimental model]. Amores, R; Fuentes, F; García, Y; Gómez-Lus, ML; Valero, E, 2000)	0.31
"Two dosage regimens of cefdinir were compared with amoxicillin/clavulanate for the treatment of suppurative acute otitis media (AOM) in children."	( Comparative safety and efficacy of cefdinir vs amoxicillin/clavulanate for treatment of suppurative acute otitis media in children. Block, SL; Hedrick, JA; Keyserling, CH; McCarty, JM; Nemeth, MA; Tack, KJ, 2000)	0.31
" Both dosing regimens of cefdinir were associated with significantly fewer gastrointestinal adverse reactions than was amoxicillin/clavulanate."	( Comparative safety and efficacy of cefdinir vs amoxicillin/clavulanate for treatment of suppurative acute otitis media in children. Block, SL; Hedrick, JA; Keyserling, CH; McCarty, JM; Nemeth, MA; Tack, KJ, 2000)	0.31
" The twice daily dosing regimen encourages better patient adherence to therapy, which is likely to improve treatment efficacy."	( Efficacy of ofloxacin and other otic preparations for acute otitis media in patients with tympanostomy tubes. Goldblatt, EL, 2001)	0.31
" pneumoniae for >40% of the dosing interval."	( Cefprozil versus high-dose amoxicillin/clavulanate in children with acute otitis media. Hedrick, JA; Pierce, P; Schwartz, RH; Sher, LD, 2001)	0.31
"The aim of this study was to compare the efficacy and safety of once daily dosing with moxifloxacin (BAY 12-8039) with that of coamoxiclav given three times daily for the treatment of acute exacerbation of chronic bronchitis (AECB)."	( A multinational, multicentre, non-blinded, randomized study of moxifloxacin oral tablets compared with co-amoxiclav oral tablets in the treatment of acute exacerbation of chronic bronchitis. Ballin, I; Bassaris, H; Hampel, B; Huchon, G; Reimnitz, P; Schaberg, T, )	0.13
" The pharmacokinetically enhanced formulation is designed to provide higher serum concentrations of amoxycillin for a longer period than standard dosing to achieve coverage of Streptococcus pneumoniae isolates with amoxycillin-clavulanic acid minimum inhibitory concentrations (MICs) up to and including 4 mg/l."	( The efficacy and safety of oral pharmacokinetically enhanced amoxycillin-clavulanate 2000/125 mg, twice daily, versus oral amoxycillin-clavulanate 1000/125 mg, three times daily, for the treatment of bacterial community-acquired pneumonia in adults. Chidiac, C; Garau, J; Petitpretz, P; Rouffiac, E; Soriano, F; Stevenson, K, 2002)	0.31
" Operationally, Rovamycin has an advantage over Augmentin for the reason that is given only twice a day as against thrice-daily dosage f orAugmentin."	( A blind parallel comparative study of the efficacy and safety of rovamycin versus augmentin in the treatment of acute otitis media. Mgbor, NC; Umeh, RE, )	0.13
" Results are in agreement with the assumption of a limited accumulation of linezolid under the dosage regimen given."	( Single- and multiple-dose pharmacokinetics of linezolid and co-amoxiclav in healthy human volunteers. Borner, K; Burkhardt, O; Köppe, P; Lode, H; Nord, CE; Pletz, MW; von der Höh, N, 2002)	0.31
"Evidence from studies in otitis media indicates that antimicrobials and dosing regimens that have equivalent bacteriologic efficacy against susceptible pathogens can have significantly different bacteriologic success rates against resistant strains of the same species."	( Achieving bacterial eradication using pharmacokinetic/pharmacodynamic principles. Dagan, R, 2003)	0.32
"Compared with 5 days of dosing, a 3 day dosing regimen of azithromycin for treatment of acute otitis media (AOM) may improve compliance, will simplify therapy for the caregiver and, by giving the same total dose as the 5 day regimen, provide more drug when the bacterial burden is highest."	( Randomized, double-blind study of the clinical efficacy of 3 days of azithromycin compared with co-amoxiclav for the treatment of acute otitis media. Aoki, J; Boettger, D; Bottenfield, G; Dunne, MW; Garrett, A; Latiolais, T; Lewis, B; Moore, WH; Pistorius, B; Shemer, A; Spiegel, C; Stewart, TD, 2003)	0.32
" The bilayer tablet provides immediate release of clavulanate and both immediate and sustained release of amoxicillin to maintain therapeutic concentrations of amoxicillin over longer periods of the dosing interval."	( Amoxicillin/clavulanate potassium extended release tablets: a new antimicrobial for the treatment of acute bacterial sinusitis and community-acquired pneumonia. Benninger, MS, 2003)	0.32
"Pharmacokinetically enhanced co-amoxiclav 2000/125 mg was designed to achieve high serum concentrations of amoxicillin over the 12 h dosing interval to eradicate Streptococcus pneumoniae with amoxicillin MICs of at least 4 mg/L."	( Oral pharmacokinetically enhanced co-amoxiclav 2000/125 mg, twice daily, compared with co-amoxiclav 875/125 mg, three times daily, in the treatment of community-acquired pneumonia in European adults. Garau, J; Garcia-Mendez, E; Rivero, A; Siquier, B; Twynholm, M, 2003)	0.32
" Monte Carlo simulations based on the pharmacokinetics of amoxicillin with or without clavulanate in humans are needed to best predict the likely efficacy of different amoxicillin dosing regimens."	( Elements of design: the knowledge on which we build. MacGowan, AP, 2004)	0.32
" These principles indicate that for amoxicillin and amoxicillin/clavulanate, a time above MIC of 35-40% of the dosing interval is predictive of high bacterial efficacy."	( Proof of concept: performance testing in models. Craig, WA, 2004)	0.32
" For amoxicillin and amoxicillin/clavulanate, a time above MIC (T > MIC) of 35-40% of the dosing interval (based on blood levels) is predictive of high bacteriological efficacy."	( Building in efficacy: developing solutions to combat drug-resistant S. pneumoniae. Jacobs, MR, 2004)	0.32
"Using pharmacokinetic/pharmacodynamic principles, pharmacokinetically enhanced amoxicillin/clavulanate 2000/125 mg twice daily was designed to provide adequate levels of amoxicillin over the 12-h dosing interval to eradicate penicillin-resistant Streptococcus pneumoniae (PRSP, penicillin MICs > or = 2 mg/L) with amoxicillin MICs of at least 4 mg/L."	( Performance in practice: bacteriological efficacy in patients with drug-resistant S. pneumoniae. Garau, J, 2004)	0.32
" In the prospective, comparative and randomized clinical study the efficacy of two treatment regimens were analyzed: XICLAV (amoxicillin + clavulanic acid): parenteral regiment with early transition to oral therapy and parenteral regimen in patients with bacterial infections without transition to the oral dosage form, on the other hand."	( [Analysis of amoxicillin-clavulanic acid (Xiclav) efficacy and the possibility of early switch from parenteral to oral therapy in the treatment of infections]. Ahmetagić, S; Bajramović, N; Calkić, L; Cengić, D; Hadzić, E; Jusufović, E; Koluder, N; Salaka, U; Sijercić, M, 2003)	0.32
" dosage regimen for both formulations, taking into account the pharmacodynamic breakpoint values for some major pathogens."	( Amoxicillin/clavulanic acid (875/125): bioequivalence of a novel Solutab tablet and rationale for a twice-daily dosing regimen. Bertola, MA; Kuipers, M; Rayer, B; Sourgens, H; Verschoor, JS, 2004)	0.32
" The once daily dosage regimen is more applicable, convenience and has better compliance."	( An open label, randomized comparative study of levofloxacin and amoxicillin/clavulanic acid in the treatment of purulent sinusitis in adult Thai patients. Bunnag, C; Dhiraputra, C; Fooanant, S; Jareoncharsri, P; Srifuengfung, S; Tunsuriyawong, P; Voraprayoon, S, 2004)	0.32
" In case of highly susceptible staphylococcal strain, highly frequent oral therapy of AMC (not longer than 8 hrs dosing interval) was also sufficiently effective."	( [Optimization of amoxicillin/clavulanate therapy based on pharmacokinetic/pharmacodynamic parameters in patients with diabetic foot infection]. Bém, R; Fejfarová, V; Jirkovská, A; Lupínková, J; Petkov, V; Sedivý, J; Stambergová, A; Ulbrichová, Z, 2004)	0.32
"Individualized optimization of amoxicillin/clavulanate dosage on the basis of growth/killing microbial dynamic parameters and antibiotic concentration/time fluctuations may enhance the antimicrobial effect and the treatment of infected non-critical ischemic diabetic foot ulcers."	( [Optimization of amoxicillin/clavulanate therapy based on pharmacokinetic/pharmacodynamic parameters in patients with diabetic foot infection]. Bém, R; Fejfarová, V; Jirkovská, A; Lupínková, J; Petkov, V; Sedivý, J; Stambergová, A; Ulbrichová, Z, 2004)	0.32
"The pharmacokinetic (PK) and pharmacodynamic (PD) profile of an antimicrobial agent provides important information that can be used to maximize bacteriologic and clinical efficacy, minimize selective pressure for the development of antimicrobial resistance, and determine an optimal dosing regimen."	( Overview of newer antimicrobial formulations for overcoming pneumococcal resistance. Craig, WA, 2004)	0.32
" Results were interpreted according to NCCLS breakpoints and pharmacokinetic/pharmacodynamic (PK/PD) breakpoints based on oral dosing regimens."	( Comparative in vitro activity of a pharmacokinetically enhanced oral formulation of amoxicillin/clavulanic acid (2000/125 mg twice daily) against 9172 respiratory isolates collected worldwide in 2000. Bajaksouzian, S; Good, CE; Jacobs, MR; Jakielaszek, C; Koeth, LM; Saunders, KA; Windau, A, 2004)	0.32
" Amoxicillin-clavulanate at 2,000/125 mg was designed to extend the therapeutic levels of amoxicillin in serum over the 12-h dosing interval, compared with conventional formulations, to eradicate bacterial strains for which amoxicillin MICs were < or =4 microg/ml while retaining efficacy against beta-lactamase-producing pathogens."	( Efficacy and safety of pharmacokinetically enhanced amoxicillin-clavulanate at 2,000/125 milligrams twice daily for 5 days versus amoxicillin-clavulanate at 875/125 milligrams twice daily for 7 days in the treatment of acute exacerbations of chronic bronc Breton, J; Sethi, S; Wynne, B, 2005)	0.33
" These data suggest that telithromycin provides effective first-line therapy for use in patients with acute maxillary sinusitis in a short and convenient once-daily dosage regimen."	( Bacteriological efficacy of 5-day therapy with telithromycin in acute maxillary sinusitis. Buchanan, P; Leroy, B; Rangaraju, M; Roos, K; Tellier, G, 2005)	0.33
"A large dosage pediatric formulation of amoxicillin/clavulanate with an improved pharmacokinetic/pharmacodynamic profile was developed to eradicate many penicillin-resistant strains of Streptococcus pneumoniae and Haemophilus influenzae (including beta-lactamase-producing strains)."	( Large dosage amoxicillin/clavulanate, compared with azithromycin, for the treatment of bacterial acute otitis media in children. Bandekar, R; Dagan, R; Hoberman, A; Huff, A; Johnson, CE; Leibovitz, E; Rosenblut, A; Wynne, B, 2005)	0.33
" In all cases, the antibiotic dosage was below the dose recommended in all guidelines."	( Acute otitis media in children--there are guidelines but are they followed? Smith, DR; Woolley, SL, 2005)	0.33
"Prevalence of surgical antimicrobial use, factors associated with use, the profile of antimicrobial use, timing, route, dosage regimen and duration of initiated prophylaxis."	( Survey of surgical antimicrobial prophylaxis in czech republic. Andrajati, R; Kolar, M; Pípalová, R; Vlcek, J, 2005)	0.33
" The timing of the first dosage was within 2 h of operation in 95."	( Survey of surgical antimicrobial prophylaxis in czech republic. Andrajati, R; Kolar, M; Pípalová, R; Vlcek, J, 2005)	0.33
" Particular areas of concern include route of administration, duration and timing of first dosage of SAP, and the inappropriate use of broad-spectrum antimicrobials."	( Survey of surgical antimicrobial prophylaxis in czech republic. Andrajati, R; Kolar, M; Pípalová, R; Vlcek, J, 2005)	0.33
"Once daily IV/PO moxifloxacin monotherapy was as least as effective as standard IV piperacillin-tazobactam/PO amoxicillin-clavulanate dosed multiple times daily for the treatment of cIAIs."	( Randomized controlled trial of moxifloxacin compared with piperacillin-tazobactam and amoxicillin-clavulanate for the treatment of complicated intra-abdominal infections. Choudhri, S; Herrington, J; Malangoni, MA; Pertel, P; Song, J, 2006)	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
" Urine samples were taken every 2 h during the whole dosing interval of the particular antibiotic."	( Urinary bactericidal activity of oral antibiotics against common urinary tract pathogens in an ex vivo model. Bedenic, B; Bubonja, M; Budimir, A; Topic, M, 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
" The development of higher dosing regimens and pharmacokinetically-enhanced formulations has allowed amoxicillin/clavulanate to continue to play an important role in the treatment of a range of infections, particularly those of the respiratory tract, in both adults and children worldwide."	( Introduction: historical perspective and development of amoxicillin/clavulanate. Geddes, AM; Klugman, KP; Rolinson, GN, 2007)	0.34
" For beta-lactams, such as penicillins, the unbound serum concentration of the drug exceeding the minimum inhibitory concentration of the causative pathogen for 40-50% of the dosing interval is predictive of bacteriologic efficacy (bacterial eradication) and can be used to determine a PK/PD breakpoint for that specific dosing regimen."	( Combating resistance: application of the emerging science of pharmacokinetics and pharmacodynamics. Jacobs, MR, 2007)	0.34
"Amoxicillin/clavulanate was first launched as a three times daily dosage for the treatment of a range of community-acquired infections."	( Development of a twice daily dosing regimen of amoxicillin/clavulanate. Bax, R, 2007)	0.34
" The model may be useful to optimize clinical trial designs and drug dosing regimens."	( A physiological model to evaluate drug kinetics in patients with hemorrhagic shock followed by fluid resuscitation. Application to amoxicillin-clavulanate. Jullien, V; Lagneau, F; Mimoz, O; Tod, M, 2008)	0.35
" In response to clinical confusion regarding the appropriate dose of amoxicillin-clavulanate, we have developed guidelines for the appropriate dosing of this second-line agent."	( Consensus guidelines for dosing of amoxicillin-clavulanate in melioidosis. Chaowagul, W; Cheng, AC; Chetchotisakd, P; Chierakul, W; Currie, BJ; Dance, DA; Limmathurotsakul, D; Peacock, SJ, 2008)	0.35
"Knowledge about the performance of dosage forms in the gastrointestinal tract is essential for the development of new oral delivery systems, as well as for the choice of the optimal formulation technology."	( Magnetic marker monitoring: high resolution real-time tracking of oral solid dosage forms in the gastrointestinal tract. Blume, H; Mönnikes, H; Weitschies, W, 2010)	0.36
" In this case series, Augmentin Duo 400/57 proved to be at least as effective as current treatments with systemic erythromycin or doxycycline with the advantage of a twice-daily dosage and a superior side-effect profile."	( Augmentin duo™ in the treatment of childhood blepharokeratoconjunctivitis. Cehajic-Kapetanovic, J; Kwartz, J, )	0.13
" Although recent guidelines based on meta-analysis suggest that perioperative chemoprophylaxis plays a role in reducing bacteraemia-related post-tonsillectomy complications, there is no evidence or agreement upon which specific antibiotic, dosage or administration route should be preferred."	( Evaluation of amoxicillin plasma and tissue levels in pediatric patients undergoing tonsillectomy. Aluffi, P; Averono, G; Bagnati, M; Basile, M; Bellomo, G; Olina, M; Vidali, M, 2010)	0.36
" CDN was bactericidal (percentage of the dosing interval for which experimental antibiotic concentrations exceeded the MIC [ft>MIC], >88%), and no recombined populations were detected from 4 h on."	( Efficacy of simulated cefditoren versus amoxicillin-clavulanate free concentrations in countering intrastrain ftsI gene diffusion in Haemophilus influenzae. Aguilar, L; Alou, L; Cafini, F; Coronel, P; Giménez, MJ; González, N; López, AM; Prieto, J; Sevillano, D; Torrico, M, 2011)	0.37
" Data recorded included the following details: an antibiotic, the prescribed dose, dosing interval, route of administration combined with the demographic factors of the patient and clinical diagnosis based on a pre-defined list."	( Assessment of antibiotic prescribing in Latvian general practitioners. Akermanis, M; Dimiņa, E; Dumpis, U; Tirāns, E; Veide, S, 2013)	0.39
" For the outcome measures, where a clinically important effect size was defined, improvements exceeded the thresholds, and a trend towards a dose-response relationship with double dose antibiotics being more efficacious."	( Antibiotic treatment in patients with chronic low back pain and vertebral bone edema (Modic type 1 changes): a double-blind randomized clinical controlled trial of efficacy. Albert, HB; Christensen, BS; Manniche, C; Sorensen, JS, 2013)	0.39
" Although guidelines continue to endorse amoxicillin as the preferred treatment, amoxicillin/clavulanate in high dosage would be the preferred treatment based on the otopathogen mix currently."	( Otitis media. Pichichero, ME, 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
"In this observational pharmacokinetic study, multiple blood samples were taken over one dosing interval of intravenous amoxicillin/clavulanic acid (1000/200 mg)."	( Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. Carlier, M; De Waele, JJ; Lipman, J; Noë, M; Roberts, JA; Stove, V; Verstraete, AG, 2013)	0.39
" Dosing simulations for amoxicillin supported the use of standard dosing regimens (30 min infusion of 1 g four-times daily or 2 g three-times daily) for most patients when using a target MIC of 8 mg/L and a pharmacodynamic target of 50% fT>MIC, except for those with a creatinine clearance >190 mL/min."	( Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. Carlier, M; De Waele, JJ; Lipman, J; Noë, M; Roberts, JA; Stove, V; Verstraete, AG, 2013)	0.39
"Although vast pharmacokinetic variability exists for both amoxicillin and clavulanic acid in intensive care unit patients, current dosing regiments are appropriate for most patients, except those with very high creatinine clearance."	( Population pharmacokinetics and dosing simulations of amoxicillin/clavulanic acid in critically ill patients. Carlier, M; De Waele, JJ; Lipman, J; Noë, M; Roberts, JA; Stove, V; Verstraete, AG, 2013)	0.39
" Indication for use was appropriate in 87% and dosage in 74% of cases."	( Evaluation of the appropriateness of intravenous amoxicillin/clavulanate prescription in a teaching hospital. Artoisenet, C; Ausselet, N; Delaere, B; Spinewine, A, )	0.13
" Individual dosing simulations were performed with MW\\Pharm."	( Is the standard dose of amoxicillin-clavulanic acid sufficient? Bruggeman, C; Haeseker, M; Havenith, T; Neef, C; Stolk, L; Verbon, A, 2014)	0.4
"Children undergoing laparoscopic appendectomy for perforated appendicitis were prospectively observed after institution of a new antibiotic regimen consisting of daily intravenous dosing ceftriaxone/metronidazole while an inpatient."	( Safety of a new protocol decreasing antibiotic utilization after laparoscopic appendectomy for perforated appendicitis in children: A prospective observational study. Alemayehu, H; Desai, AA; Holcomb, GW; St Peter, SD, 2015)	0.42
"There is little data available to guide amoxicillin-clavulanic acid dosing in critically ill children."	( Augmented renal clearance implies a need for increased amoxicillin-clavulanic acid dosing in critically ill children. Barker, CI; Carlier, M; De Cock, PA; de Jaeger, A; De Paepe, P; Delanghe, JR; Dhont, E; Robays, H; Standing, JF; Verstraete, AG, 2015)	0.42
"To describe the population pharmacokinetics of oral amoxicillin and to compare the PTA of current dosing regimens."	( Non-linear absorption pharmacokinetics of amoxicillin: consequences for dosing regimens and clinical breakpoints. de Velde, F; de Winter, BC; Koch, BC; Mouton, JW; van Gelder, T, 2016)	0.43
" The PTA was computed using Monte Carlo simulations for several dosing regimens."	( Non-linear absorption pharmacokinetics of amoxicillin: consequences for dosing regimens and clinical breakpoints. de Velde, F; de Winter, BC; Koch, BC; Mouton, JW; van Gelder, T, 2016)	0.43
" Cumulative exposure to any antimicrobial in the previous 6 months has a monotonic dose-response association with CA-CDI."	( Cumulative and temporal associations between antimicrobial prescribing and community-associated Clostridium difficile infection: population-based case-control study using administrative data. Bennie, M; Bryson, S; Davey, P; Kavanagh, K; Marwick, C; Pan, J; Robertson, C; Wiuff, C, 2017)	0.46
"This analysis demonstrated temporal and dose-response associations between CA-CDI risk and antimicrobials, with an impact of exposure to high-risk antimicrobials remaining 4-6 months later."	( Cumulative and temporal associations between antimicrobial prescribing and community-associated Clostridium difficile infection: population-based case-control study using administrative data. Bennie, M; Bryson, S; Davey, P; Kavanagh, K; Marwick, C; Pan, J; Robertson, C; Wiuff, C, 2017)	0.46
"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
"To calculate the clavulanic acid exposure of oral amoxicillin/clavulanic acid dosing regimens, to investigate variability using a population pharmacokinetic model and to explore target attainment using Monte Carlo simulations."	( Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis. De Velde, F; De Winter, BCM; Koch, BCP; Mouton, JW; Van Gelder, T, 2018)	0.48
" The model developed here may serve to suggest clavulanic acid dosing regimens to optimize efficacy and prevent underdosing."	( Highly variable absorption of clavulanic acid during the day: a population pharmacokinetic analysis. De Velde, F; De Winter, BCM; Koch, BCP; Mouton, JW; Van Gelder, T, 2018)	0.48
" For amoxicillin and amoxicillin/clavulanate, the target was free antibiotic concentration remaining above the minimum inhibitory concentration (MIC) for ≥50% of the dosing interval (fT>MIC≥50%), whereas for cefuroxime axetil and cefotaxime, the target was fT>MIC≥60%."	( Application of pharmacokinetic/pharmacodynamic analysis to evaluate the adequacy of antimicrobial therapy for pediatric acute otitis media in Spain before and after the introduction of the PCV7 vaccine. Canut-Blasco, A; Ibar-Bariain, M; Isla, A; Rodríguez-Gascón, A; Solinís, MA, 2019)	0.51
" 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
" Here we use co-amoxiclav (a clinically important combination of the β-lactam antibiotic amoxicillin and the β-lactamase inhibitor clavulanate) to ask whether treatment efficacy and resistance evolution can be decoupled via component dosing modifications."	( Modified Antibiotic Adjuvant Ratios Can Slow and Steer the Evolution of Resistance: Co-amoxiclav as a Case Study. Allen, RC; Brown, SP, 2019)	0.51
" In only 13 of 138 patients with impaired or unknown renal function the dosage regimen was adjusted."	( The appropriateness of antimicrobial use in the outpatient clinics of three hospitals in the Netherlands. Jimmink, A; Lauw, FN; Lettinga, KD; Prins, JM; van den Broek, AK; van Hest, RM; Visser, CE, 2020)	0.56
" Interventions were any antibiotic prophylaxis (any dosage regimen, any route of administration or at any time during delivery or the puerperium)."	( Antibiotic prophylaxis for operative vaginal delivery. Choobun, T; Islam, QM; Liabsuetrakul, T; Peeyananjarassri, K, 2020)	0.56
" On the basis of these results, orally dosing hens with amoxicillin and clavulanic acid tablets at 125 mg/kg PO q12h does not reach therapeutic plasma concentrations."	( Pharmacokinetics and Drug Residue in Eggs After Multiple-Day Oral Dosing of Amoxicillin-Clavulanic Acid in Domestic Chickens. Bailey, J; Cox, SK; Davis, R; Fortner, C; Gerhardt, L; Shannon, L; Souza, MJ, 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
" While all isolates were fully susceptible at standard dosing regimen to amoxicillin-clavulanate, most were only susceptible at increased exposure or resistant to piperacillin-tazobactam."	( Antimicrobial susceptibility testing of Eggerthella lenta blood culture isolates at a university hospital in Belgium from 2004 to 2018. De Geyter, D; Declerck, B; Piérard, D; Van der Beken, Y; Wybo, I, 2021)	0.62
" Our investigations excluded other possible causes for deranged LFTs and there was no improvement of same despite reduced dosing of potentially hepatotoxic medications."	( Prednisolone: role in amoxicillin-clavulanate-induced cholestatic liver injury. Chigozie, R; Khan, I; Lee, MQ; O'Mara, G, 2021)	0.62
" The treatment with prednisolone in the amount of 50 mg/day, amoxicillin and clavulanic acid in the amount of 1000 mg twice per day and Diflucan in a dosage of 50 mg/day for 15 days was prescribed."	( A case of polymorphic dermal angiitis in a B-cell chronic lymphocytic leukemia patient during rituximab therapy. Grabovskaya, O; Kayumova, L; Morozova, E; Smirnova, L; Teplyuk, N, 2022)	0.72
" Results obtained from this study aid in ameliorating current dosing regimens to optimise antibiotic efficacy; however, more in-depth amoxicillin and clavulanic acid y-site compatibility studies are warranted."	( Stability of Amoxicillin and Clavulanic Acid in Separate Containers for Administration via a Y-Site. Barton, S; Fawaz, S; Merzouk, M; Nabhani-Gebara, S, 2021)	0.62
"In critically ill children, severely altered pharmacokinetics may result in subtherapeutic β-lactam antibiotic concentrations when standard pediatric dosing regimens are applied."	( Suboptimal Beta-Lactam Therapy in Critically Ill Children: Risk Factors and Outcome. De Cock, PAJG; De Paepe, P; Delanghe, JR; Dhont, E; Herck, I; Stove, V; Van Der Heggen, T; Vanhaesebrouck, S; Verstraete, AG; Willems, J, 2022)	0.72
"Post hoc analysis of the "Antibiotic Dosing in Pediatric Intensive Care" study (NCT02456974, 2012-2019)."	( Suboptimal Beta-Lactam Therapy in Critically Ill Children: Risk Factors and Outcome. De Cock, PAJG; De Paepe, P; Delanghe, JR; Dhont, E; Herck, I; Stove, V; Van Der Heggen, T; Vanhaesebrouck, S; Verstraete, AG; Willems, J, 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
" A pilot study on amoxicillin-clavulanate that used a portion of the study animals demonstrated empirically that dosing twice a day was efficacious."	( Evaluation of Amoxicillin and Amoxicillin-Clavulanate (Augmentin) for Antimicrobial Postexposure Prophylaxis Following Bacillus anthracis Inhalational Exposure in Cynomolgus Macaques. Hatch, GJ; Hewitt, JA; Slay, RM, 2022)	0.72
"Uroliths dissolved in 8 of 11 dogs in a median of 2 months (range, 1 to 4 months) with a final effective dosage of d,l-methionine of approximately 100 mg/kg, PO, every 12 hours."	( d,l-Methionine in combination with amoxicillin-clavulanic acid successfully dissolves spontaneously occurring infection-induced struvite urocystoliths in dogs: a pilot study. Bartges, JW; Harris, ASM; Moyers, TD, 2023)	0.91

Timeframe	Studies, This Drug (%)	All Drugs %
pre-1990	232 (8.91)	18.7374
1990's	510 (19.58)	18.2507
2000's	784 (30.10)	29.6817
2010's	825 (31.67)	24.3611
2020's	254 (9.75)	2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Publication Type	This drug (%)	All Drugs (%)
Trials	612 (21.65%)	5.53%
Reviews	224 (7.92%)	6.00%
Case Studies	728 (25.75%)	4.05%
Observational	20 (0.71%)	0.25%
Other	1,243 (43.97%)	84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (164)

Trial Overview

Trial	Phase	Enrollment	Study Type	Start Date	Status
Efficacy and Tolerability of Systemic Methylprednisolone in Children and Adolescents With Chronic Rhinosinusitis [NCT01205984]	Phase 4	48 participants (Actual)	Interventional	2007-07-31	Completed
A Comparison of Single Preoperative Dose of Co-amoxiclav Versus Postoperative Full Course of Amoxicillin/ Co-amoxiclav in Prevention of Postoperative Complications in Dentoalveolar Surgery: a Randomized Controlled Trial [NCT03844776]		135 participants (Anticipated)	Interventional	2019-10-02	Recruiting
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 3	458 participants (Actual)	Interventional	2010-07-21	Completed
Prospective Randomized Clinical Trial Comparing Efficacy Surgical Versus Medical Treatment of Osteomyelitis in Diabetic Foot Ulcers [NCT01137903]		88 participants (Anticipated)	Interventional	2010-04-30	Recruiting
Comparison of Postoperative Infection and Graft Uptake Rate Using Single Dose of Intravenous Co-amoxiclav Versus no Antibiotic in Children Undergoing Myringoplasty [NCT03700814]	Phase 4	60 participants (Actual)	Interventional	2014-01-10	Completed
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 2	58 participants (Actual)	Interventional	2019-02-11	Completed
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 2	22 participants (Actual)	Interventional	2020-08-17	Completed
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 4	385 participants (Actual)	Interventional	2016-12-02	Completed
Open-label, Randomized, Crossover, Two-period, Two-sequence, Single-center, Comparative Bioequivalence Study of Clavamox, Film-coated Tablets, 875 mg + 125 mg (Pharmtechnology LLC, Belarus), and Augmentin®, Film-coated Tablets, 875 mg + 125 mg (GlaxoSmith [NCT03702894]	Phase 1	56 participants (Actual)	Interventional	2018-09-21	Completed
Are Prophylactic Antibiotics Necessary Before Laparoscopic Living Kidney Donation? A Double Blind, Randomised, Controlled Trial. [NCT02089568]	Phase 4	284 participants (Actual)	Interventional	2012-07-31	Completed
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 1	11 participants (Actual)	Interventional	2014-03-06	Terminated(stopped due to Not enough patient enrollment and lack of staffing)
Single Intraoperative Intravenous Enhancin[Co-amoxiclav] Versus Postoperative Full Oral Course in Prevention of Post Adenotonsillectomy Morbidity:A Randomised Clinical Trial. [NCT01267942]		126 participants (Actual)	Interventional	2008-05-31	Completed
The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines [NCT01089218]	Phase 4	241 participants (Actual)	Interventional	2008-04-30	Completed
Pharmacokinetics and Pleural Fluid Penetration of Amoxicillin and Clavulanic Acid in Patients With Pleural Infections [NCT04350502]		11 participants (Actual)	Interventional	2020-04-04	Completed
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)	Interventional	2014-01-31	Recruiting
Pneumonia in Children: Aetiology, Ideal Antibiotic Duration, Quality of Life [NCT02258763]	Phase 4	19 participants (Actual)	Interventional	2014-11-30	Completed
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 1	48 participants (Actual)	Interventional	2002-08-31	Completed
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 1	52 participants (Actual)	Interventional	2003-09-30	Completed
Evaluation of the Efficacy of an Antibiotic Combined With Standard Treatment in Severe Alcoholic Hepatitis [NCT02281929]	Phase 3	297 participants (Actual)	Interventional	2015-06-13	Completed
[NCT02431832]	Phase 1	17 participants (Actual)	Interventional	2015-02-28	Completed
Population Pharmacokinetics of Anti-tuberculosis Drugs in Children With Tuberculosis [NCT03625739]		800 participants (Anticipated)	Observational [Patient Registry]	2018-07-01	Recruiting
Study Of The Antibiotic Role In Post Tonsillectomy Complications [NCT03491085]	Phase 1/Phase 2	200 participants (Anticipated)	Interventional	2018-05-15	Not yet recruiting
Open-label, Randomized, Crossover, Two-period, Two-sequence, Single-center, Comparative Bioequivalence Study of Clavamox, Powder for Oral Suspension, 400 mg + 57 mg / 5 ml (Pharmtechnology LLC, Belarus), and Augmentin®, Powder for Oral Suspension, 400 mg [NCT03616301]	Phase 1	56 participants (Actual)	Interventional	2018-07-28	Completed
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)	Observational	2023-11-01	Not yet recruiting
An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics and Safety of Augmentin Extra Strength (ES)-600 Suspension in Children Presenting With Community Acquired Pneumonia (CAP) and Acute Bacterial Rhinosinusitis (ABRS) in Brazil [NCT05340257]	Phase 2	24 participants (Anticipated)	Interventional	2023-06-23	Not yet recruiting
Antibiotic PRophylAxis Based on infeCTIve Risk in Cardiac Implantable Electronic Device - PRACTICE Study [NCT04736979]		1,044 participants (Actual)	Observational	2017-01-01	Completed
A Multicenter, Open-label, Non-comparative Phase IV Clinical Study to Evaluate the Safety and Clinical Efficacy of Augmentin Extra Strength (ES)-600 in Children With Acute Otitis Media (AOM) in India [NCT04600752]	Phase 4	310 participants (Actual)	Interventional	2022-01-12	Completed
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 3	98 participants (Anticipated)	Interventional	2022-02-02	Recruiting
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 1	48 participants (Actual)	Interventional	2002-08-31	Completed
A Clinical Study to Evaluate the Effect of Glutathion S-transferase Polymorphism on Pharmacokinetics/Pharmacodynamics After Multiple Administration of Amoxicillin/Clavulanate and Explore Biomarkers for Drug-induced Liver Injury (DILI) [NCT02143323]	Phase 1	32 participants (Actual)	Interventional	2013-12-31	Completed
DIABOLO Trial: A Multicenter Randomized Clinical Trial Investigating the Cost-effectiveness of Treatment Strategies With or Without Antibiotics for Uncomplicated Acute Diverticulitis. [NCT01111253]	Phase 4	533 participants (Anticipated)	Interventional	2010-05-31	Active, not recruiting
Antibiotic-associated Gastrointestinal Side Effects and the Role of the Gut Microbiome [NCT04156555]	Phase 4	30 participants (Actual)	Interventional	2019-08-01	Completed
The Role of Oral Steroids in the Management of Chronic Rhinosinusitis Without Nasal Polyps [NCT02927834]		24 participants (Actual)	Interventional	2015-08-31	Completed
Routine vs. Clinically-Directed Antibiotic Treatment in Snake Bite With Local Envenomation: a Randomised Controlled Trial [NCT02570347]	Phase 4	130 participants (Anticipated)	Interventional	2016-04-30	Recruiting
Effects of Phenoximethylpenicillin, Amoxicillin and Amoxicillin-clavulanic Acid on the Gut Microbiota of Healthy Volunteers: a Randomized Clinical Trail [NCT04084106]	Phase 4	104 participants (Actual)	Interventional	2019-09-10	Completed
Comparing Oral Versus Parenteral Antimicrobial Therapy (COPAT) Trial [NCT05977868]	Phase 4	135 participants (Anticipated)	Interventional	2023-08-04	Enrolling 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 1	52 participants (Actual)	Interventional	2003-09-30	Completed
An Open Label, Single Arm Study, to Evaluate the Pharmacokinetics of LP-001 Oral Suspension in Children With a Bacterial Infection [NCT05584683]	Phase 1	24 participants (Anticipated)	Interventional	2022-12-12	Not yet recruiting
Target Attainment and Pharmacokinetics of Antimicrobials in Non-critically Ill Surgery Patients [NCT03120663]		120 participants (Anticipated)	Observational	2016-11-30	Recruiting
Home Intravenous Versus Oral Antibiotics Following Appendectomy for Perforated Appendicitis in Children, a Randomized Controlled Trial [NCT02724410]		82 participants (Actual)	Interventional	2011-01-31	Completed
Clindamycin Versus Amoxicillin With Clavulanic Acid in Prevention of Early Dental Implants Failure [NCT04980170]	Early Phase 1	100 participants (Anticipated)	Interventional	2021-11-01	Not yet recruiting
Use of Perioperative Antibiotics in Endoscopic Sinus Surgery [NCT03369717]	Phase 4	400 participants (Anticipated)	Interventional	2018-08-01	Suspended(stopped due to Expired IRB approval since 05/07/2020)
Antibiotic Dosing in Pediatric Intensive Care [NCT02456974]		640 participants (Anticipated)	Observational [Patient Registry]	2012-05-31	Recruiting
Use of Prophylactic Antibiotics Prior to OnabotulinumtoxinA Treatment of Overactive Bladder: a Randomized Controlled Trial [NCT05519072]	Phase 4	140 participants (Anticipated)	Interventional	2022-08-16	Recruiting
Early Bactericidal Activity of Cephalexin and Amoxicillin-clavulanate for Susceptible Tuberculosis - BLAST 1 Trial [NCT05664568]	Phase 2	30 participants (Anticipated)	Interventional	2023-03-15	Recruiting
Efficacy of Antimicrobials in Young Children With Acute Otitis Media (AOM) [NCT00377260]	Phase 4	291 participants (Actual)	Interventional	2006-11-30	Completed
Randomized, Embedded, Multifactorial Adaptive Platform Trial for Community- Acquired Pneumonia [NCT02735707]	Phase 3	10,000 participants (Anticipated)	Interventional	2016-04-11	Recruiting
Benefit of a Single Preoperative Dose of Antibiotics in a Sub-Saharan District Hospital: Minimal Input, Massive Impact [NCT00801099]		276 participants (Actual)	Interventional	2004-12-31	Completed
Randomized Controlled Trial Comparing Long and Short Duration of Antibiotic Prophylaxis for Patients Undergoing Sinus Lift Surgery [NCT02764710]	Phase 3	250 participants (Anticipated)	Interventional	2016-05-31	Not yet recruiting
Pharmacodynamic Drug Interaction Between Warfarin and Amoxicillin-clavulanic Acid [NCT00603317]	Phase 4	13 participants (Actual)	Interventional	2008-03-31	Completed
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 3	437 participants (Actual)	Interventional	2003-05-31	Completed
Comparison of Intravenous Co-amoxiclav Versus Benzyl Penicillin in Children With Severe Tonsillitis [NCT04215770]		310 participants (Actual)	Interventional	2018-01-01	Completed
Application of LiveSpo Navax® in the Treatment Support of Acute Rhinosinusitis and Acute Otitis Media [NCT05804123]		120 participants (Anticipated)	Interventional	2021-10-28	Recruiting
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 4	302 participants (Actual)	Interventional	2016-12-31	Active, 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 3	902 participants (Actual)	Interventional	2003-01-31	Completed
Prophylaxis of Surgical Wound Infection in Incisional Hernia Repair With Topical Antibiotics (PROTOP-PAR) [NCT05508152]	Phase 3	260 participants (Actual)	Interventional	2021-02-01	Completed
Nasal Steroids, Irrigation, Oral Antibiotics, and Subgroup Targeting for Effective Management of Sinusitis [NCT06076304]	Phase 4	144 participants (Anticipated)	Interventional	2023-12-31	Not yet recruiting
Efficacy of Tympanostomy Tubes for Children With Recurrent Acute Otitis Media [NCT02567825]		250 participants (Actual)	Interventional	2015-11-30	Completed
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 4	293 participants (Actual)	Interventional	2006-02-28	Terminated(stopped due to The study was prematurely terminated due to slow enrollment beyond the planned study timelines.)
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 4	1,372 participants (Actual)	Interventional	2008-03-31	Completed
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 2	35 participants (Actual)	Interventional	2009-01-31	Completed
Supportive Care and Antibiotics for Severe Pneumonia Among Hospitalized Children [NCT04041791]	Phase 3	4,392 participants (Anticipated)	Interventional	2019-08-19	Recruiting
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)	Interventional	2006-06-30	Completed
[NCT04082598]	Phase 4	165 participants (Actual)	Interventional	2016-10-01	Completed
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 3	60 participants (Actual)	Interventional	2008-02-29	Completed
Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in Febrile UTIs Caused by ESBL-producing Enterobacterales (PACUTI) [NCT05224401]	Phase 3	330 participants (Anticipated)	Interventional	2023-05-29	Recruiting
Short (5 Days) Versus Long (14 Days) Duration of Antimicrobial Therapy for Acute Bacterial Sinusitis in Children [NCT01166945]		98 participants (Actual)	Interventional	2010-11-30	Completed
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 3	41 participants (Actual)	Interventional	2010-12-31	Terminated(stopped due to Trial terminated early per business decision)
Effect of Irrigation With Antibiotic-containing Solutions Versus Sodium Hypochlorite on Postoperative Pain and Intra-canal Bacteria in Teeth With Necrotic Pulps (a Randomized Double-blind Clinical Trial) [NCT04035070]	Phase 4	51 participants (Anticipated)	Interventional	2021-01-31	Not yet recruiting
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 3	2,229 participants (Actual)	Interventional	2022-10-18	Active, not recruiting
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 3	344 participants (Actual)	Interventional	2016-10-31	Completed
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 4	1,325 participants (Actual)	Interventional	2017-06-01	Completed
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)	Interventional	2006-06-30	Completed
Beta-lactam Monotherapy Versus Beta-lactam - Macrolide Association as Empiric Antibiotherapy Strategies in Non-severe Hospitalized Community-acquired Pneumonia: a Randomized, Non-inferiority, Open Trial. [NCT00818610]	Phase 4	601 participants (Actual)	Interventional	2009-01-31	Completed
A Comparison Study Between Cefdinir and Amoxicilline/Clavulanate in Patients With Acute Sinusitis and Assessment of Quality of Life (QOL) [NCT00147914]	Phase 4	100 participants (Actual)	Interventional	2005-02-28	Completed
A Prospective, Randomized Trial of Antibiotic Duration in Post-appendectomy Abscess [NCT03795194]	Phase 4	12 participants (Actual)	Interventional	2019-05-01	Terminated(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 1	66 participants (Actual)	Interventional	2019-07-23	Completed
Perianal Abscess Recurrence and Fistula Formation: Antibiotics Following Incision and Drainage Trial - (PARFAIT) A Vanguard Randomized Controlled Trial [NCT04549311]	Phase 3	15 participants (Actual)	Interventional	2021-11-18	Active, 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 2	112 participants (Actual)	Interventional	2017-08-23	Completed
A Non-Inferiority, Multicentered, Controlled, Randomized, Double Blinded Study Investigating the Antibiotic Treatment Duration (3-day Versus 8-day) for Subjects Admitted to Emergency Services With Acute Non-severe Community Acquired Pneumonia (CAP) [NCT01963442]	Phase 2	310 participants (Anticipated)	Interventional	2013-11-30	Recruiting
Phase I Study of Safety and Immunogenicity of ADU-623, a Live-attenuated Listeria Monocytogenes Strain (ΔactA/ΔinlB) Expressing the EGFRvIII-NY-ESO-1 Vaccine, in Patients With Treated and Recurrent WHO Grade III/IV Astrocytomas [NCT01967758]	Phase 1	11 participants (Actual)	Interventional	2014-01-08	Completed
A Randomised Control Trial to Determine Whether a 5 Day Course of Antibiotics is More Clinically and Cost Effective Than a 24 Hour Prophylactic Course for the Prevention of Surgical Site Infection Following Lower Limb Amputation [NCT02018094]	Phase 4	160 participants (Actual)	Interventional	2013-10-08	Completed
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 2	140 participants (Anticipated)	Interventional	2021-12-01	Recruiting
CAT BITE Antibiotic Prophylaxis and Durations for the Hand/Forearm (CATBITE): A Prospective, Randomized, Placebo-controlled, Double-blinded, Clinical Trial [NCT05846399]	Phase 4	72 participants (Anticipated)	Interventional	2023-09-07	Recruiting
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 3	41 participants (Actual)	Interventional	2010-12-31	Terminated(stopped due to Trial terminated early per business decision)
Use of Pathological Phenotype to Determine Optimal Management for Moderate to Severe Preschool Wheeze [NCT02517099]	Phase 2	60 participants (Actual)	Interventional	2015-06-05	Completed
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)	Interventional	2005-09-30	Completed
Antibiotic Treatment Versus no Antibiotics in the Postoperative Acute Cholecystitis Low and Moderately Severe [NCT01015417]	Phase 3	414 participants (Actual)	Interventional	2010-05-31	Completed
Open-label Comparative Safety and Efficacy Study of Levofloxacin and Amoxicillin Clavulanic Acid in Patients With Acute ,Bacterial Rhinosinusitis [NCT02712502]		100 participants (Actual)	Observational	2014-09-30	Completed
Fast-track Absolute Neutrophil Count in Suspected Neutropenic Fever (The FRANCiS-NF Trial): A Single-centre, Pragmatic, Open-label, Randomised, Controlled Trial [NCT05393505]	Phase 4	344 participants (Anticipated)	Interventional	2022-10-24	Recruiting
Exploratory Pilot Studies to Demonstrate Mechanisms of Preventing Antibiotic-Associated Diarrhea and the Role for Probiotics [NCT04414722]	Early Phase 1	138 participants (Actual)	Interventional	2021-01-01	Completed
Prophylactic Versus Clinically-driven Antibiotics in Comatose Survivors of Out-of-hospital Cardiac Arrest [NCT02899507]	Phase 4	60 participants (Actual)	Interventional	2013-09-30	Completed
The Efficiency of Postoperative Antibiotics in Orthognathic Surgery: A Prospective, Randomized, Double-blind, Placebo-controlled Clinical Trial [NCT02740647]		25 participants (Anticipated)	Interventional	2016-04-30	Not yet recruiting
[NCT00185939]	Phase 2/Phase 3	125 participants	Interventional	2003-08-31	Completed
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)	Interventional	2013-03-31	Recruiting
Antibiotic Prophylaxis for Percutaneous Endoscopic Gastrostomy (PEG) in Children: a Randomised Controlled Trial. [NCT01870167]	Phase 4	90 participants (Anticipated)	Interventional	2013-01-31	Recruiting
Use of Antibiotics to Eradicate Bacterial Pathogens Colonising the Colonic Mucosa in Ulcerative Colitis Patients [NCT00355602]		40 participants (Anticipated)	Interventional	2006-07-31	Completed
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 3	400 participants (Anticipated)	Interventional	2007-07-31	Recruiting
The Effect of a Combination of Systemic Steroids and Antibiotics on Obstructive Sleep Apnea Syndrome in Children [NCT00456339]	Phase 4	4 participants (Actual)	Interventional	2006-07-31	Terminated(stopped due to Problems recruiting; patient relapse following treatment)
Quadruple Therapy Using Esomeprazole, Colloidal Bismuth Subcitrate, Amoxicillin-Clavulanate, and Furazolidone in Patients Who Failed to Eradicate H. Pylori With Triple Therapy [NCT00520949]		176 participants (Actual)	Interventional	2006-10-31	Completed
Clinical Relevance of Middle Meatal Bacteriology During Acute Respiratory Infection in Children - Randomised, Double-Blinded Clinical Study [NCT00545961]	Phase 4	120 participants (Anticipated)	Interventional	2007-11-30	Not 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 4	350 participants (Anticipated)	Interventional	2023-08-16	Recruiting
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)	Interventional	2019-10-18	Completed
Phase 4 Efficacy Study of Antimicrobials in the Treatment of Acute Otitis Media in Young Children [NCT00299455]	Phase 4	320 participants (Anticipated)	Interventional	2006-03-31	Active, not recruiting
Effects of Pre-operative Antibiotics on the Wound Healing Following Clinical Crown Lengthening Surgery [NCT05925179]	Phase 4	28 participants (Anticipated)	Interventional	2023-08-01	Not yet 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 4	195 participants (Actual)	Interventional	2004-12-31	Completed
A Prospective Randomized Multicentric Trial Comparing Amoxicillin/Clavulanate Potassium Therapy to Appendectomy for Acute Non Complicated Appendicitis [NCT00135603]		243 participants (Actual)	Interventional	2004-02-29	Completed
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry [NCT01244581]	Phase 3	84 participants (Actual)	Interventional	1999-09-30	Completed
Antibiotics for Severe Perineal Laceration to Prevent Infection Following Repair [NCT04573504]	Phase 4	274 participants (Anticipated)	Interventional	2020-09-23	Recruiting
Bacteriological Study of Acute Follicular Tonsillitis in Patients Attending the ENT Outpatient Clinic of Assiut University Hospital [NCT04321733]		66 participants (Anticipated)	Observational	2020-04-30	Not yet recruiting
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 3	161 participants (Actual)	Interventional	2012-09-30	Completed
[NCT00042718]	Phase 3	659 participants (Actual)	Interventional	2001-11-30	Completed
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 3	1,643 participants (Actual)	Interventional	2002-11-30	Completed
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)	Interventional	2002-04-30	Terminated(stopped due to low accrual)
Reduced Clavulanate Formulation of Amoxicillin-Clavulanate in Children 6-23 Months With Acute Otitis Media [NCT02630992]	Phase 3	112 participants (Actual)	Interventional	2015-12-31	Completed
Higher Versus Standard Dose of Amoxicillin-clavulanate in Pediatric Protracted Bacterial Bronchitis: a Randomized Controlled Study. [NCT04378231]		100 participants (Anticipated)	Interventional	2020-05-31	Not yet recruiting
Phase 1 Study to Evaluate the Effect of Oral Administration of Tebipenem Pivoxil Hydrobromide on Normal Human Intestinal Microbiota in Healthy Volunteers [NCT04376554]	Phase 1	30 participants (Actual)	Interventional	2020-02-10	Completed
PROTOP: Study of the Efficacy of Topical Antibiotherapy in the Prophylaxis of Incisional Surgical Localization Infection in Colorectal Surgery [NCT03574090]	Phase 4	268 participants (Actual)	Interventional	2020-10-20	Completed
Initial Antibiotics and Delayed Appendectomy for Acute Appendicitis [NCT01697059]		73 participants (Actual)	Interventional	2012-09-30	Completed
Comparing Post-drainage Treatment of Peritonsillar Abscesses With Antibiotics (Clavulin or Clindamycin) to Treating With Placebo - a Double-blinded Randomized Control Trial [NCT01715610]		0 participants (Actual)	Interventional	2012-05-24	Withdrawn(stopped due to unsuccessful recruitment)
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 3	100 participants (Actual)	Interventional	2010-05-31	Terminated(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)	Interventional	2012-09-30	Recruiting
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 1	35 participants (Actual)	Interventional	2011-03-22	Completed
Bacterial Infections Associated With Healthcare (Healthcare-Associated) in Hospitalized Cirrhotic Patients: Randomized Study of Use of Traditional Empirical Antibiotic Therapy and Second-line Targeted at Multi-resistant Bacteria [NCT01820026]	Phase 4	96 participants (Anticipated)	Interventional	2012-12-31	Recruiting
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)	Observational	2006-10-31	Completed
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)	Interventional	2012-04-30	Completed
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 3	27 participants (Actual)	Interventional	2013-08-30	Completed
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 1	52 participants (Actual)	Interventional	2006-01-19	Completed
Clinical Trial of the Treatment of Acute Sinusitis With Standard-dose Versus High-dose Amoxicillin/Clavulanate [NCT02340000]	Phase 4	315 participants (Actual)	Interventional	2014-11-18	Completed
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 3	674 participants (Actual)	Interventional	2018-09-18	Completed
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 3	7 participants (Actual)	Interventional	2010-12-31	Terminated(stopped due to Trial terminated early per business decision)
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 3	0 participants (Actual)	Interventional	2022-03-01	Withdrawn(stopped due to No enrolment due to Covid-19)
Fast Track Therapeutic Model in Acute Complicated Appendicitis in Pediatrics [NCT05761080]	Phase 4	158 participants (Anticipated)	Interventional	2021-04-22	Recruiting
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 3	97 participants (Actual)	Interventional	2016-04-30	Terminated(stopped due to Development not proceeding)
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 4	314 participants (Anticipated)	Interventional	2016-06-30	Active, not recruiting
2-day Prophylactic Antibiotic is Effective in Transoral Endoscopic Thyroidectomy [NCT04268407]		60 participants (Actual)	Interventional	2020-02-26	Completed
Comparison of Two Lengths of Treatment in Early-onset Ventilated Associated Pneumonia [NCT01559753]	Phase 4	225 participants (Actual)	Interventional	1998-01-31	Completed
Non-operative Management of Uncomplicated Appendicitis With an Appendicolth in Children [NCT02189668]		14 participants (Actual)	Interventional	2014-07-31	Terminated(stopped due to High failure rate)
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 2	103 participants (Actual)	Interventional	2019-02-21	Completed
Antibiotic Prophylaxis in Critically Ill Patients After Suspected Aspiration [NCT05079620]	Phase 4	100 participants (Anticipated)	Interventional	2021-11-30	Recruiting
The HYsteroscopic Miscarriage MaNagement (HYMMN) Trial [NCT04751500]		149 participants (Actual)	Interventional	2021-01-31	Completed
Efficacy of Antibiotics in Children With Acute Sinusitis: Which Subgroups Benefit? [NCT02554383]	Phase 3	515 participants (Actual)	Interventional	2016-02-29	Completed
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 3	1,395 participants (Actual)	Interventional	2018-09-18	Completed
Delineation of Therapeutic Potential and the Causal Relationship Between Vitamin D and Helicobacter Pylori (HP) Infection and Gastritis [NCT03142620]	Phase 3	96 participants (Anticipated)	Interventional	2015-03-31	Recruiting
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 2	520 participants (Actual)	Interventional	2012-01-31	Terminated(stopped due to The primary objective of the study was met.)
Comparing Efficacy of Postoperative Antibiotic Use in Transoral Thyroidectomy: a Prospective Randomized Controlled Trial Study [NCT03295955]		50 participants (Anticipated)	Interventional	2017-09-04	Recruiting
Efficacy of Seven-day Combined Rabeprazole Plus Levofloxacin Plus Augmentin for Eradication of Helicobacter Pylori. [NCT01575899]	Phase 4	208 participants (Actual)	Interventional	2007-12-31	Terminated(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)	Interventional	2012-03-31	Completed
Oral-only Antibiotics for Bone and Joint Infections in Children - A Nationwide Randomized Controlled Trial [NCT04563325]	Phase 4	180 participants (Actual)	Interventional	2020-09-15	Active, not recruiting
Antibiotic Prophylaxis and Renal Damage In Congenital Abnormalities of the Kidney and Urinary Tract [NCT02021006]	Phase 3	292 participants (Actual)	Interventional	2013-12-31	Active, not recruiting
Prophylactic Antibiotics After Functional Endoscopic Sinus Surgery: a Randomized, Double-blind Placebo Controlled Trial [NCT01919411]	Phase 4	134 participants (Actual)	Interventional	2013-02-28	Completed
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 3	104 participants (Anticipated)	Interventional	2020-04-30	Not yet recruiting
Surgical Site Infection Following Episiotomy Repair in Relation to Routine Use of Postpartum Antibiotic Prophylaxis in Low Risk Population: A Randomized Controlled Trial [NCT06154720]		200 participants (Actual)	Observational	2022-09-10	Completed
Effect of Amoxicillin/Clavulanic Acid Combination on Postoperative Endodontic Pain in Patients With Symptomatic Apical Periodontitis: A Randomized Controlled Trial [NCT03007342]		78 participants (Anticipated)	Interventional	2017-01-31	Not yet recruiting
A Randomized Cohort Trial Evaluating Duration of Antibiotic Therapy as Part of Maximal Medical Therapy for Chronic Rhinosinusitis [NCT01825408]	Phase 4	40 participants (Actual)	Interventional	2013-02-28	Completed
Determining the Necessity for Postoperative Antibiotics After Salivary Stent Placement [NCT03333408]	Phase 4	40 participants (Anticipated)	Interventional	2018-06-15	Recruiting
The Evaluation of Postoperative Antibiotics in Non-Infected Mandible Fractures [NCT04198129]	Phase 1	174 participants (Anticipated)	Interventional	2020-10-01	Recruiting
Antibiotic Prophylaxis in Ragged Placental Membranes: A Prospective, Multicenter, Randomized Trial [NCT03459599]		716 participants (Actual)	Interventional	2016-10-01	Completed
Collaborative Urological Prosthetics Investigation Directive Research Group [NCT05100654]		800 participants (Anticipated)	Interventional	2022-04-22	Recruiting
Evaluating Pharmacokinetics and Whole Blood Bactericidal Activity Against Mycobacterium Tuberculosis of Single Doses of Faropenem Plus Amoxicillin/Clavulanic Acid in Healthy Volunteers [NCT02393586]	Phase 1	43 participants (Actual)	Interventional	2015-02-28	Completed
Intravenous to Oral Antibiotic Switch Therapy for Probable Neonatal Bacterial Infections: Clinical Efficacy, Safety and Cost-effectiveness [NCT03247920]	Phase 4	510 participants (Actual)	Interventional	2017-11-04	Completed
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 4	1,538 participants (Actual)	Interventional	2018-04-03	Completed
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 4	762 participants (Actual)	Interventional	2006-06-30	Completed
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 4	472 participants (Actual)	Interventional	2013-03-21	Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

Trial	Outcome
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 Mean Number of Emergency Room Visits 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 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 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 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 Mean Number of Antibiotic Prescriptions, Exclusive of Study Medication, According to Treatment Assignment
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 Distribution of Clinical Failures by the End-of-therapy Visit 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 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 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 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 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
NCT00493038 (5) [back to overview]	Number of Participants With Response (Microbiologically Valid Patients)
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 (Per-protocol Population)
NCT00493038 (5) [back to overview]	Number of Participants With Response (Intent-to-treat Population)
NCT00797108 (8) [back to overview]	Number of Participants With Microbiological Response at Test of Cure (TOC) Visit
NCT00797108 (8) [back to overview]	Number of Participants With Categorical Change From Baseline in Vital Signs
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 Abnormal Physical Examination Findings
NCT00797108 (8) [back to overview]	Number of Participants With Abnormal Laboratory Test Findings
NCT00797108 (8) [back to overview]	Number of Participants Who Died
NCT00797108 (8) [back to overview]	Percentage of Participants With Clinical 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
NCT00801099 (1) [back to overview]	Number of Participants With Surgical Site Infections
NCT00835705 (6) [back to overview]	Cmax (Maximum Observed Concentration) - Amoxicillin
NCT00835705 (6) [back to overview]	Cmax (Maximum Observed Concentration) - 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)] - Clavulanic Acid
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
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]	AUC0-inf [Area Under the Concentration-time Curve From Time Zero to Infinity (Extrapolated)] - Clavunlanic 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-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]	Cmax (Maximum Observed Concentration) - Amoxicillin
NCT00836901 (6) [back to overview]	Cmax (Maximum Observed Concentration) - 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 Amoxicillin
NCT00840099 (6) [back to overview]	Bioequivalence Based on Cmax for Clavulanic Acid
NCT00840099 (6) [back to overview]	Bioequivalence Based on AUC0-inf for Clavulanic Acid
NCT00840099 (6) [back to overview]	Bioequivalence Based on AUC0-inf for Amoxicillin
NCT00840840 (6) [back to overview]	Bioequivalence Based on AUC0-t for Amoxicillin
NCT00840840 (6) [back to overview]	Bioequivalence Based on AUC0-t for Clavulanic Acid
NCT00840840 (6) [back to overview]	Bioequivalence Based on Cmax for Amoxicillin
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 Clavulanic Acid
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]	Clinical Response at Test-of-Cure (TOC) Visit in Subjects With Bacteriologically Confirmed Complicated Intra-abdominal Infection (cIAI)
NCT01069900 (20) [back to overview]	Clinical Response at the End-of-Treatment (EOT) Visit
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 Adverse Events
NCT01069900 (20) [back to overview]	Number of Subjects With Clinical Cardiac 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]	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
NCT01069900 (20) [back to overview]	Bacteriological Response at a 'During Therapy' 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]	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 Improvement Rate at End of IV (EIV) Visit
NCT01110382 (7) [back to overview]	Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at End of IV (EIV) 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]	Number of Participants With Favorable Per-pathogen Microbiological Outcome Rate at Test Of Cure (TOC) Visit
NCT01110382 (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 Late Follow-Up (LFU) Visit
NCT01110408 (7) [back to overview]	The Number of Participants With Favorable Per-participant Microbiological Response
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 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
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
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 Favorable Per-participant Microbiological Response Rate
NCT01110421 (7) [back to overview]	The Number of Participants With Clinical Improvement Rate at End of IV (EIV) 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 Symptom Rating 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
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 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 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 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 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 for Whom Diaper Dermatitis Was Reported and Associated With Study Product
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 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 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 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 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 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 Mean Rate, Per Month, of Protocol AOM Recurrences and Relapses Within 60 Days of Enrollment
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
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 6 Week Follow-up, Non-Illness Visits During the Respiratory Season at Which a Nonsusceptible Pathogen is Recovered
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 AOM Recurrences for Which the Follow-up Nasopharyngeal (NP) Culture at the Day 12-14 Visit Yields a Nonsusceptible Haemophilus Influenzae (H Flu) Isolate
NCT01561703 (1) [back to overview]	Healthcare Utilization
NCT01575899 (3) [back to overview]	Re-eradication Rate
NCT01575899 (3) [back to overview]	Eradication Rate of Participants Living in Rural Area.
NCT01575899 (3) [back to overview]	Eradication Rate (Participants Naive to Anti-H. Pylori Treatment)
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]	Lund Kennedy Endoscopic Score
NCT01919411 (6) [back to overview]	Lund Kennedy Endoscopic Score
NCT01919411 (6) [back to overview]	Sinonasal Outcome Test - 22
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]	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
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)
NCT02189668 (2) [back to overview]	Number of Participants That Did Not Have an Appendectomy
NCT02189668 (2) [back to overview]	Number of Participants With Complicated Appendicitis
NCT02340000 (6) [back to overview]	"Subjective Improvement - Day 3 (Rating of a Lot Better or no Symptoms)"
NCT02340000 (6) [back to overview]	SNOT-16 - Day 10
NCT02340000 (6) [back to overview]	Nasal Colonization With Resistant Bacteria
NCT02340000 (6) [back to overview]	Willingness to Take the Study Antibiotic in the Future
NCT02340000 (6) [back to overview]	Subjective Improvement - Day 10
NCT02340000 (6) [back to overview]	SNOT-16 - Day 3
NCT02517099 (4) [back to overview]	Health Related Quality of Life
NCT02517099 (4) [back to overview]	Number of Courses of Oral Steroids
NCT02517099 (4) [back to overview]	Number of Unscheduled Healthcare Visits (UHCV)
NCT02517099 (4) [back to overview]	Symptom Days
NCT02554383 (8) [back to overview]	The Distribution of Children Compliant With Study Medication
NCT02554383 (8) [back to overview]	The Distribution of Children Experiencing Treatment Failure (TF)
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 Receiving a Systemic Antibiotic Over the First 10 Days of Follow-up
NCT02554383 (8) [back to overview]	The Distribution of Children With a Nonsusceptible Pathogen at the Follow-up Visit
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 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 Developing Acute Otitis Media (AOM) Over the First 10 Days of Follow-up
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 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
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 Mean Score Representing Parental Satisfaction With Clinical Management
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 Rate of Occurrence of Acute Otitis Media (AOM) Episodes Per Child-Year
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
NCT02567825 (12) [back to overview]	The Mean Scores on the 6 Item Caregiver Impact Questionnaire (CIQ)
NCT02567825 (12) [back to overview]	The Mean Scores on the 6 Item Quality of Life Survey Questionnaire (OM-6)
NCT02605122 (4) [back to overview]	Summary of Clinical Cure
NCT02605122 (4) [back to overview]	Summary of Clinical Improvement
NCT02605122 (4) [back to overview]	Summary of Early Clinical Response
NCT02605122 (4) [back to overview]	Overview of Adverse Events By Treatment Arm
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]	Distribution of Population Plasma Concentration of Amoxicillin According to Time For Participants Receiving Formulation 1
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 2 for Whom Protocol-Defined Diarrhea (PDD) 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 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
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
NCT02724410 (4) [back to overview]	Number of Participants With Wound Infections
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 Persistent or Worsening Pneumonia During Medically Attended Visits
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 All Causes 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]	Resolution of Symptoms (a Component of DOOR)
NCT02891915 (10) [back to overview]	Resolution of Symptoms (a Component of DOOR)
NCT02927834 (3) [back to overview]	Nasal Endoscopy
NCT02927834 (3) [back to overview]	CT Scan Changes
NCT02927834 (3) [back to overview]	Sinonasal Outcome Test (SNOT 20)
NCT03174184 (5) [back to overview]	Distribution of Minimum Inhibitory Concentration (MIC) of Rifampin
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]	AUC for Rifampin
NCT03174184 (5) [back to overview]	Estimate the Antimycobacterial Activity Based on Liquid Culture Time-to-positivity
NCT03174184 (5) [back to overview]	Frequency of Grade 2 or Higher Adverse Events
NCT03357614 (2) [back to overview]	Percentage of Participants With Overall Success
NCT03357614 (2) [back to overview]	Percentage of Participants With Microbiologic 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]	Change in Community Diversity (Shannon Diversity Index) From Pre run-in Baseline
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]	Level of Fecal SCFA Propionate
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)

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.

Intervention	visits (Number)
Amoxicillin-Clavulanate	33
Placebo	33

Intervention	participants (Number)
	Colonization with penicillin-susceptible S. pn	No colonization with penicillin-susceptible S. pn
Amoxicillin-Clavulanate	7	121
Placebo	17	112

Intervention	Participants (Number)
	Number of children with worsening symptoms	Number of children unchanged or improved
Amoxicillin-Clavulanate	31	112
Placebo	39	104

Intervention	participants (Number)
	Presence of at least one AOM pathogen	Absence of any AOM pathogen	Presence of Streptococcus pneumoniae	Absence of Streptococcus pneumoniae	Presence of Haemophilus influenzae	Absence of Haemophilus influenzae	Presence of Moraxella catarrhalis	Absence of Moraxella catarrhalis	Presence of Streptococcus pyogenes	Absence of Streptococcus pyogenes
Amoxicillin-Clavulanate	63	67	18	112	45	85	9	121	0	130
Placebo	88	43	46	85	44	87	38	93	3	128

Intervention	participants (Number)
	Mastoiditis	Perforation of tympanic membrane	Protocol-defined diarrhea	Diaper dermatitis	Oral thrush	Vomiting	Rash
Amoxicillin-Clavulanate	0	1	36	73	7	12	1
Placebo	1	7	22	51	1	12	2

Intervention	participants (Number)
	Clinical failures by the end of therapy visit	Subjects not classified as clinical failures
Amoxicillin-Clavulanate	23	119
Placebo	73	70

Intervention	participants (Number)
	Clinical failures by the on therapy visit	Subjects not classified as clinical failures
Amoxicillin-Clavulanate	5	138
Placebo	34	111

Intervention	AOM-SOS score (Mean)
	Day 1 PM	Day 2 AM	Day 2 PM	Day 3 AM	Day 3 PM	Day 4	Day 5	Day 6	Day 7
Amoxicillin-Clavulanate	5.80	4.12	3.78	2.86	2.82	2.40	1.93	1.40	1.28
Placebo	6.20	4.85	4.33	3.37	3.25	2.68	2.41	2.31	1.94

Intervention	participants (Number)
	Resolved by Day 1 - PM	Censored by Day 1 - PM	Resolved by Day 2 - AM	Censored by Day 2 - AM	Resolved by Day 2 - PM	Censored by Day 2 - PM	Resolved by Day 3 - AM	Censored by Day 3 - AM	Resolved by Day 3 - PM	Censored by Day 3 - PM	Resolved by Day 4	Censored by Day 4	Resolved by Day 5	Censored by Day 5	Resolved by Day 6	Censored by Day 6	Resolved by Day 7	Censored by Day 7
Amoxicillin-Clavulanate	0	1	17	1	29	1	34	1	50	1	58	1	70	1	80	1	96	48
Placebo	0	2	8	2	20	3	29	3	42	4	51	5	63	5	69	5	76	71

Intervention	Participants (Number)
	Bacteriological success	Failure	Missing / Indeterminate
Amoxicillin/Clavulanate	23	0	3
Moxifloxacin (Avelox, BAY12-8039)	19	0	2

Intervention	participants (Number)
	Eradication	Persistence	Not Applicable
Ceftriaxone and Amoxicillin/Clavulanate	3	0	1
Sulopenem (Multi Intravenous Dose) and PF-03709270	4	0	1
Sulopenem (Single Intravenous Dose) and PF-03709270	4	0	0

Intervention	probability of effusion (Mean)
	Right ear	Left ear
Amoxicillin-Clavulanate	.32	.33
Placebo	.41	.41

Intervention	probability of effusion (Mean)
	Right ear	Left ear
Amoxicillin-Clavulanate	.28	.27
Placebo	.32	.37

Intervention	probability of effusion (Mean)
	Right ear	Left ear
Amoxicillin-Clavulanate	.36	.39
Placebo	.42	.48

Intervention	participants (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/Clavulanate	1	1	2	0
Sulopenem (Multi Intravenous Dose) and PF-03709270	2	1	2	1
Sulopenem (Single Intravenous Dose) and PF-03709270	0	2	0	4

Intervention	units 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/Clavulanate	2.57	-1.74	-1.52
Sulopenem (Multi Intravenous Dose) and PF-03709270	2.75	-2.02	-1.89
Sulopenem (Single Intravenous Dose) and PF-03709270	2.17	-1.43	-1.39

Intervention	percentage of participants (Number)
	Cure	Failure	Indeterminate
Ceftriaxone and Amoxicillin/Clavulanate	62.5	25.0	12.5
Sulopenem (Multi Intravenous Dose) and PF-03709270	87.5	12.5	0
Sulopenem (Single Intravenous Dose) and PF-03709270	90.0	10.0	0

Intervention	percentage of participants (Number)
	EOT: Cure	EOT: Improvement	EOT: Failure	Follow-up: Cure	Follow-up: Failure	Follow-up: Indeterminate
Ceftriaxone and Amoxicillin/Clavulanate	75.0	12.5	12.5	62.5	12.5	25.0
Sulopenem (Multi Intravenous Dose) and PF-03709270	75.0	25.0	0.0	87.5	0.0	12.5
Sulopenem (Single Intravenous Dose) and PF-03709270	60.0	30.0	10.0	90.0	0.0	10.0

Intervention	Percentage of subjects (Number)
	Presumed Persistence	Presumed Eradication	Indeterminate
Comparator Ertapenem	2.2	94.9	2.9
Moxifloxacin (Avelox, BAY12-8039)	6.8	84.7	8.4

Intervention	Percentage of subjects (Number)
	Clinical Improvement	Clinical Failure	Indeterminate
Comparator Ertapenem	98	0.7	1.4
Moxifloxacin (Avelox, BAY12-8039)	94.3	1	4.7

Intervention	Percentage of subjects (Number)
	Clinical Cure	Clinical Failure	Indeterminate
Comparator Ertapenem	95.3	2	2.7
Moxifloxacin (Avelox, BAY12-8039)	86.2	5.7	8.1

Intervention	Percentage of subjects (Number)
	Resolution	Clinical Failure	Indeterminate
Comparator Ertapenem	98	0.7	1.4
Moxifloxacin (Avelox, BAY12-8039)	92.2	4.6	3.2

Intervention	milliseconds (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 Ertapenem	417.34	2.2905	412.7945	1
Moxifloxacin (Avelox, BAY12-8039)	419.5872	9.731	419.2055	9.2509

Intervention	Beats 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 Ertapenem	90.4	0.3	82.6	-0.9
Moxifloxacin (Avelox, BAY12-8039)	93.4	2.8	84.3	1

amoxicillin-potassium clavulanate combination

Description

Cross-References

Synonyms (1)

Research Excerpts

Toxicity

Pharmacokinetics

Compound-Compound Interactions

Bioavailability

Dosage Studied

Research

Studies (2,605)

Study Types

Clinical Trials (164)

Trial Overview

Trial Outcomes

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

The Mean Number of Emergency Room Visits According to Treatment Assignment

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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 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

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

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

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

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

Number of Participants With Response (Microbiologically Valid Patients)

Number of Participants With Response (Microbiologically Valid Patients)

Number of Participants With Response (Per-protocol Population)

Number of Participants With Response (Per-protocol Population)

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

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

Number of Participants With Categorical Change From Baseline in Vital Signs

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

Number of Participants With Abnormal Physical Examination Findings

Number of Participants With Abnormal Laboratory Test Findings

Number of Participants Who Died

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

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

Number of Participants With Surgical Site Infections

Cmax (Maximum Observed Concentration) - Amoxicillin

Cmax (Maximum Observed Concentration) - Clavulanic Acid

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

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

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

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

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

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

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

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

Cmax (Maximum Observed Concentration) - Amoxicillin

Cmax (Maximum Observed Concentration) - Clavulanic Acid

Bioequivalence Based on AUC0-t for Amoxicillin

Bioequivalence Based on AUC0-t for Clavulanic Acid

Bioequivalence Based on Cmax for Amoxicillin

Bioequivalence Based on Cmax for Clavulanic Acid

Bioequivalence Based on AUC0-inf for Clavulanic Acid

Bioequivalence Based on AUC0-inf for Amoxicillin