Compounds > cilastatin, imipenem drug combination
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cilastatin, imipenem drug combination

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Description

Cilastatin, Imipenem Drug Combination: Combination of imipenem and cilastatin that is used in the treatment of bacterial infections; cilastatin inhibits renal dehydropeptidase I to prolong the half-life and increase the tissue penetration of imipenem, enhancing its efficacy as an anti-bacterial agent. [Medical Subject Headings (MeSH), National Library of Medicine, extracted Dec-2023]

Cross-References

ID SourceID
PubMed CID17756656
CHEMBL ID1628401
MeSH IDM0130282

Synonyms (14)

Synonym
imipenem - cilastatin
thienam
tienam 500
cilastatin, imipenem drug combination
92309-29-0
cilastatin / imipenem
1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid, 6-((1r)-1-hydroxyethyl)-3-((2-((iminomethyl)amino)ethyl)thio)-7-oxo-, (5r,6s)-, mixt. with (2z)-7-(((2r)-2-amino-2-carboxyethyl)thio)-2-((((1s)-2,2-dimethylcyclopropyl)carbonyl)amino)-2-heptenoic acid
imipenem / cilastatin
imipenem and cilastatin
tainem
1-azabicyclo(3.2.0)hept-2-ene-2-carboxylic acid, 6-(1-hydroxyethyl)-3-((2-((iminomethyl)amino)ethyl)thio)-7-oxo-, (5r-(5alpha,6alpha(r*)))-, mixt. with (r-(r*,s*-(z)))-7-((2-amino-2-carboxyethyl)thio)-2-(((2,2-dimethylcyclopropyl)carbonyl)amino)-2-heptano
CHEMBL1628401
imipenem-cilastatin sodium hydrate
(z)-7-[(2r)-2-amino-2-carboxyethyl]sulfanyl-2-[[(1s)-2,2-dimethylcyclopropanecarbonyl]amino]hept-2-enoic acid;(5r,6s)-3-[2-(aminomethylideneamino)ethylsulfanyl]-6-[(1r)-1-hydroxyethyl]-7-oxo-1-azabicyclo[3.2.0]hept-2-ene-2-carboxylic acid

Research Excerpts

Toxicity

ExcerptReferenceRelevance
" Adverse effects were generally mild and reversible and included diarrhea alone or with vomiting (5."( Imipenem-cilastatin in pediatric patients: an overview of safety and efficacy in studies conducted in the United States.
Ahonkhai, VI; Brown, KR; Cyhan, GM; Wilson, SE, 1989)		0.28
" In the remaining two patients treatment had to be prematurely discontinued due to adverse effects."( Efficacy and safety of imipenem/cilastatin in the empirical treatment of septicemia.
Del Valle, J; Noriega, AR; Otero, JR; Revilla, AP; Sanz, F, 1987)		0.27
" Because VCM has the adverse reaction of nephrotoxicity, we are apprehensive about using VCM with other antibiotics, which might increase this problem."( [Nephrotoxicity and drug interaction of vancomycin (2)].
Nakagawa, Y; Toyoguchi, T, 1996)		0.29
"719]) were the most frequently reported adverse events."( The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections: analysis of pooled clinical trial data.
Babinchak, T; Dartois, N; Ellis-Grosse, E; Loh, E; Rose, GM, 2005)		0.33
"435]) were the most frequently reported adverse events."( A multicenter trial of the efficacy and safety of tigecycline versus imipenem/cilastatin in patients with complicated intra-abdominal infections [Study ID Numbers: 3074A1-301-WW; ClinicalTrials.gov Identifier: NCT00081744].
Babinchak, T; Campos, M; Ellis-Grosse, EJ; Loh, E; Oliva, ME; Pasternak, J; Rekha, A; Rose, GM; Yellin, A, 2005)		0.33
" Most commonly reported treatment emergent adverse events for tigecycline and imipenem/cilastatin were nausea (14."( The efficacy and safety of tigecycline for the treatment of complicated intra-abdominal infections - the European experience.
Babinchak, T; Castaing, N; Cooper, A; Dartois, N; De Vane, N; Fomin, P; Koalov, S; Tellado, J, 2008)		0.35
" Drug-induced seizures are a rare but serious adverse effect, with carbapenems being one of the most common classes of antibiotics associated with seizures."( Safety of imipenem/cilastatin in neurocritical care patients.
Brophy, GM; Hoffman, J; Trimble, J, 2009)		0.35
" The overall incidence of treatment-emergent adverse events was 80."( Efficacy and safety of tigecycline monotherapy vs. imipenem/cilastatin in Chinese patients with complicated intra-abdominal infections: a randomized controlled trial.
Bi, J; Chen, X; Chen, Z; Cooper, A; Leng, X; Li, R; Liu, D; Ma, X; Maroko, R; Quan, Z; Wei, J; Wu, J; Wu, Z; Yan, L; Yu, Y; Zhang, Y, 2010)		0.36
" We compared the incidence of adverse events in hospitalized infants receiving meropenem versus imipenem/cilastatin."( Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants.
Benjamin, DK; Capparelli, EV; Clark, RH; Cohen-Wolkowiez, M; Herring, AH; Hornik, CP; Kearns, GL; Smith, PB; van den Anker, J, 2013)		0.39
" Multivariable conditional logistic regression was performed to evaluate the association between carbapenem therapy and adverse events, controlling for infant factors and severity of illness."( Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants.
Benjamin, DK; Capparelli, EV; Clark, RH; Cohen-Wolkowiez, M; Herring, AH; Hornik, CP; Kearns, GL; Smith, PB; van den Anker, J, 2013)		0.39
"In this cohort of infants, meropenem was associated with more frequent but less severe adverse events when compared with imipenem/cilastatin."( Adverse events associated with meropenem versus imipenem/cilastatin therapy in a large retrospective cohort of hospitalized infants.
Benjamin, DK; Capparelli, EV; Clark, RH; Cohen-Wolkowiez, M; Herring, AH; Hornik, CP; Kearns, GL; Smith, PB; van den Anker, J, 2013)		0.39
"0% of patients, respectively, had treatment-emergent adverse events."( Prospective, randomized, double-blind, Phase 2 dose-ranging study comparing efficacy and safety of imipenem/cilastatin plus relebactam with imipenem/cilastatin alone in patients with complicated urinary tract infections.
Akers, W; Brown, ML; Du, J; Kartsonis, NA; Lee, YC; Mariyanovski, V; McLeroth, P; Paschke, A; Pedley, A; Sims, M, 2017)		0.46
" Adverse events (AEs) were reported in 74."( The safety and efficacy of relebactam/imipenem/cilastatin in Japanese patients with complicated intra-abdominal infection or complicated urinary tract infection: A multicenter, open-label, noncomparative phase 3 study.
Aoyama, N; Bando, H; Brown, M; Kawahara, K; Kikukawa, H; Kohno, S; Paschke, A; Shirakawa, M; Takase, A; Yoneyama, F, 2021)		0.62
"We conducted a meta-analysis of clinical trials comparing novel carbapenem-β-lactamase inhibitor combinations with comparators to assess the clinical and microbiological responses, mortality, and adverse events (AEs)."( Efficacy and safety of novel carbapenem-β-lactamase inhibitor combinations: Results from phase II and III trials.
Luo, Q; Shen, P; Xiao, Y; Xiong, L; Yu, W, 2022)		0.72
" Serious adverse events were reported in 36 (40%) of 91 patients in the sulbactam-durlobactam group and 42 (49%) of 86 patients in the colistin group."( Efficacy and safety of sulbactam-durlobactam versus colistin for the treatment of patients with serious infections caused by Acinetobacter baumannii-calcoaceticus complex: a multicentre, randomised, active-controlled, phase 3, non-inferiority clinical tri
Altarac, D; Chen, L; Du, B; Isaacs, R; Kaye, KS; Lewis, D; Miller, A; O'Donnell, J; Poirier, GE; Rana, K; Reinhart, H; Shorr, AF; Srinivasan, S; Wunderink, RG, 2023)		0.91
" No severe or life-threatening adverse events were encountered."( Effectiveness and Safety of Intra-arterial Imipenem/Cilastatin Sodium Infusion for Patients with Hand Osteoarthritis-Related Interphalangeal Joint Pain.
Huang, HH; Liang, KW; Tsao, TF; Tyan, YS; Wang, B; Wang, PH, 2023)		0.91

Pharmacokinetics

ExcerptReferenceRelevance
" Intravenously administered FCE 22101 at a dose of 250 mg gave peak plasma concentrations of about 12 mg/l and the plasma half-life was about 60 min."( Pharmacokinetics in healthy subjects of FCE 22101 and its acetoxymethyl ester, FCE 22891: effect of co-administration of imipenem/cilastatin on the renal metabolism of FCE 22101.
Burman, LA; Cassinelli, G; Corigli, R; Dornbusch, K; Franceschi, G; Norrby, SR; Sassella, D, 1990)		0.28
"96 mg/l), plasma half-life (60 min), volume of distribution (0."( Pharmacokinetics of imipenem/cilastatin in neutropenic patients with haematological malignancies.
Farrell, I; Janmohamed, RM; Kelly, J; Leyland, MJ, 1990)		0.28
"76 hours, and the half-life of CS tended to be longer than that of IPM."( [Pharmacokinetic and clinical evaluations of imipenem/cilastatin sodium in neonates and premature infants].
Fujimoto, T; Kawakami, A; Koga, T; Motohiro, T; Oda, K; Sakata, Y; Shimada, Y; Tanaka, K; Tominaga, K; Tomita, S, 1989)		0.28
" Drug levels in plasma and the peritoneal dialysis fluid were analyzed at frequent intervals, and various pharmacokinetic variables were calculated for a one-compartment open model."( Pharmacokinetics of imipenem-cilastatin in patients with renal insufficiency undergoing continuous ambulatory peritoneal dialysis.
Freimer, EH; Gross, ML; Higgins, JT; Somani, P, 1988)		0.27
" Pharmacokinetic studies were performed in the 11 children and in 10 of the neonates."( Pharmacokinetic and clinical evaluation of imipenem/cilastatin in children and neonates.
Baron, S; Bégué, PC; Challier, P; Fontaine, JL; Lasfargues, G, 1987)		0.27
"To determine the appropriate compartmental and noncompartmental pharmacokinetic parameters for intravenous piperacillin and tazobactam."( Piperacillin-tazobactam pharmacokinetics in patients with intraabdominal infections.
Burm, JP; Gill, MA; Jhee, SS; Kern, JW; Yellin, AE, )		0.13
"The estimated noncompartmental pharmacokinetic parameters (mean +/- SD) for piperacillin and tazobactam, respectively, were as follows: maximum concentration in plasma 218."( Piperacillin-tazobactam pharmacokinetics in patients with intraabdominal infections.
Burm, JP; Gill, MA; Jhee, SS; Kern, JW; Yellin, AE, )		0.13
" Therefore, knowledge of the impact of continuous haemofiltration on drug elimination and the pharmacokinetic profile of drugs is essential to good clinical management."( Clinical pharmacokinetics during continuous haemofiltration.
Bressolle, F; de la Coussaye, JE; Eledjam, JJ; Galtier, M; Kinowski, JM; Wynn, N, 1994)		0.29
" Imipenem pharmacokinetic parameters were determined in 10 anuric patients with renal failure managed by continuous venovenous hemofiltration (CVVH)."( Comparison of imipenem pharmacokinetics in patients with acute or chronic renal failure treated with continuous hemofiltration.
Macias, WL; Mueller, BA; Scarim, SK, 1993)		0.29
" Pharmacokinetic parameters were based on an open two-compartment model and a noncompartmental technique."( Serum bactericidal activities and comparative pharmacokinetics of meropenem and imipenem-cilastatin.
Borner, K; Dreetz, M; Eller, J; Hamacher, J; Koeppe, P; Lode, H; Schaberg, T, 1996)		0.29
"h/ml in the chimpanzee) and a longer half-life at beta phase (1."( Pharmacokinetics in nonhuman primates of a prototype carbapenem active against methicillin-resistant Staphylococcus aureus.
Cama, L; Kropp, H; Sasor, MW; Sundelof, JG; Thompson, R; White, KM, 1996)		0.29
" Pharmacokinetic variables were calculated by a first-order, two-compartment pharmacokinetic model for both substances."( Pharmacokinetics of imipenem-cilastatin in critically ill patients undergoing continuous venovenous hemofiltration.
Bremer, F; Brune, K; Geisslinger, G; Oelkers, R; Schobel, H; Schüttler, J; Tegeder, I, 1997)		0.3
"To investigate the pharmacokinetic characteristics of Imipenem/cilastatin in burn patients during the acute phase."( [Study on the pharmacokinetics of Imipenem cilastatin in burn patients during the acute phase].
Peng, Y; Wang, H; Xiao, G, 2000)		0.31
"Compared to those in control group, pharmacokinetic parameters of Imipenem exhibited evident difference, such as prolonged half-life [(1."( [Study on the pharmacokinetics of Imipenem cilastatin in burn patients during the acute phase].
Peng, Y; Wang, H; Xiao, G, 2000)		0.31
" Pharmacokinetic parameters, obtained from previously published studies in healthy volunteers were used to simulate the %T > MIC for 10,000 patients receiving imipenem-cilastatin, meropenem, and piperacillin/tazobactam."( Pharmacodynamic modeling of beta-lactam antibiotics for the empiric treatment of secondary peritonitis: a report from the OPTAMA program.
Kotapati, S; Kuti, JL; Nicolau, DP, 2005)		0.33
"The bactericidal exposures necessary for positive clinical outcomes among skin and soft tissue infections are largely dependent on interpatient pharmacokinetic variability and pathogen drug susceptibility."( Pharmacodynamic modeling of imipenem-cilastatin, meropenem, and piperacillin-tazobactam for empiric therapy of skin and soft tissue infections: a report from the OPTAMA Program.
Kuti, JL; Nicolau, DP; Ong, CT, 2005)		0.33
"This phase I study assessed the intrapulmonary pharmacokinetic profiles of relebactam (MK-7655), a novel β-lactamase inhibitor, and imipenem."( Intrapulmonary Pharmacokinetics of Relebactam, a Novel β-Lactamase Inhibitor, Dosed in Combination with Imipenem-Cilastatin in Healthy Subjects.
Bi, S; Butterton, JR; Chavez-Eng, CM; Gotfried, MH; Jumes, PA; Mangin, E; Rhee, EG; Rizk, ML; Zhang, Z; Zhao, T, 2018)		0.48
" This decision was based on substantial clinical and pre-clinical data, including rigorous pharmacokinetic and pharmacodynamic work, and is an important step forward in the management of these debilitating conditions."( Clinical Pharmacokinetics and Pharmacodynamics of Imipenem-Cilastatin/Relebactam Combination Therapy.
McCarthy, MW, 2020)		0.56
" The pharmacokinetic profile is a beta-lactam one: no oral absorption, and with a wide distribution within the vascular space and the interstitial fluid of well vascularized tissues, reaching therapeutic concentrations in the alveolar lavage fluid and within the macrophage."( Pharmacokinetics/Pharmacodynamics and tolerability of cefiderocol in the clinical setting.
Azanza Perea, JR; Sádaba Díaz de Rada, B, 2022)		0.72

Compound-Compound Interactions

ExcerptReferenceRelevance
"In a randomised and coordinated multicentre study, 143 patients with severe infections received treatment with either imipenem/cilastatin (72; I/C group) or cefotaxime combined with metronidazole and optional cloxacillin (71; CX/M/CL group)."( Imipenem/cilastatin as monotherapy in severe infections: comparison with cefotaxime in combination with metronidazole and cloxacillin. Report from a Norwegian Study Group.
, 1987)		0.27
" These results indicate that IPM/CS alone produces of good response in moderate to severe respiratory infections while IPM/CS combined with AMK is useful in intractable respiratory infections."( [Imipenem/cilastatin sodium alone or combined with amikacin sulfate in respiratory infections].
Ichikawa, Y; Ishibashi, T; Oizumi, K; Takamoto, M; Tamaru, N; Tanaka, H; Tokunaga, N; Toyoshima, H; Watanabe, K; Yoshida, M, 1994)		0.29
" Therefore, the nephrotoxic effects and pharmacokinetics of VCM were examined in rabbits and compared with those in rabbits administered with VCM and other antibiotics."( [Nephrotoxicity and drug interaction of vancomycin (2)].
Nakagawa, Y; Toyoguchi, T, 1996)		0.29
"Convulsant activity of pazufloxacin mesilate (PZFX mesilate), a new quinolone antibacterial agent for intravenous use, in combination with nonsteroidal anti-inflammatory drug (NSAID) was investigated in mice after intravenous or intracerebroventricular administration."( [Drug interactions between nonsteroidal anti-inflammatory drug and pazufloxacin mesilate, a new quinolone antibacterial agent for intravenous use: convulsions in mice after intravenous or intracerebroventricular administration].
Fukuda, H; Kawamura, Y, 2002)		0.31
"β-Lactamase inhibitors with a bicyclic urea core and a variety of heterocyclic side chains were prepared and evaluated as potential partners for combination with imipenem to overcome class A and C β-lactamase mediated antibiotic resistance."( Discovery of MK-7655, a β-lactamase inhibitor for combination with Primaxin®.
Blizzard, TA; Bodner, R; Chen, H; Fitzgerald, P; Gude, C; Ha, S; Hairston, N; Hammond, ML; Hermes, J; Imbriglio, J; Kim, S; Lu, J; Ogawa, A; Painter, RE; Park, YW; Raghoobar, S; Scapin, G; Sharma, N; Wisniewski, D; Wu, J; Young, K, 2014)		0.4
" SIGNIFICANCE AND IMPACT OF THE STUDY: Drug combination is an effective approach for the treatment of resistant bacterial infection."( In vitro interactions of ambroxol hydrochloride or amlodipine in combination with antibacterial agents against carbapenem-resistant Acinetobacter baumannii.
Li, X; Lu, C; Sun, S; Wang, D; Wang, Y, 2020)		0.56

Bioavailability

ExcerptReferenceRelevance
" Bioavailability was 93."( Pharmacokinetics of imipenem after intravenous, intramuscular and subcutaneous administration to cats.
Albarellos, GA; Denamiel, GA; Landoni, MF; Lupi, MP; Montoya, L; Quaine, PC, 2013)		0.39

Dosage Studied

ExcerptRelevanceReference
"To report a case of Pseudomonas aeruginosa endocarditis that was successfully treated with high-dose imipenem/cilastatin and to discuss dosage modification based on individual pharmacokinetic parameters."( Successful use of higher-than-recommended dosage of imipenem in Pseudomonas aeruginosa endocarditis.
Hrdy, DB; Kailath, EJ; King, JH, 1992)		0.28
" Dosage may need to be adjusted to body size in order to obtain optimal serum concentrations and activity."( Successful use of higher-than-recommended dosage of imipenem in Pseudomonas aeruginosa endocarditis.
Hrdy, DB; Kailath, EJ; King, JH, 1992)		0.28
" (22) and other dosages (a change in dosing regimen, 2)."( [Clinical study of intramuscular imipenem/cilastatin sodium in the field of obstetrics and gynecology].
Banzai, M; Chimura, T; Kanasugi, H; Kihara, K; Matsuo, M; Miyata, R; Oda, T; Takahashi, H; Yamazaki, K; Yokoyama, Y, 1991)		0.28
" Mean imipenem AUCss (area under the concentration-time curve over a dosage interval at steady state) values were 38."( Steady-state pharmacokinetics of intramuscular imipenem-cilastatin in elderly patients with various degrees of renal function.
Bland, JA; Graziani, AL; Lawson, LA; MacGregor, RR; Pietroski, NA; Rogers, JD, 1991)		0.28
" Dosing regimens in evaluable patients were 500 mg every 12 h (45."( Intramuscular imipenem/cilastatin in multiple-dose treatment regimens: review of the worldwide clinical experience.
Calandra, GB; Garau, J, 1991)		0.28
"Imipenem is the broadest-spectrum antibiotic currently available but requires frequent intravenous dosing for efficacy."( Overall clinical utility of the intramuscular preparation of imipenem/cilastatin.
MacGregor, RR, 1991)		0.28
" Pharmacists evaluated I/C dosage based upon culture/sensitivity results and indicators of renal function."( Evaluation of an imipenem/cilastatin target drug program.
Abel, SR; Guba, EA, 1991)		0.28
" This dose should be the starting dose for a period of 12-h dosing intervals until the next IHF procedure."( Pharmacokinetics of intravenous imipenem/cilastatin during intermittent haemofiltration.
Alarabi, AA; Cars, O; Danielson, BG; Salmonson, T; Wikström, B, 1990)		0.28
" Up to six hours after dosing the concentrations in prostatic secretions ranged between 1 and 2 mg/l."( [Imipenem/cilastatin: in vitro activity, concentrations in plasma and prostatic adenoma and therapeutic results in patients with complicated urinary tract infections].
Adam, D; Bauernfeind, A; Hönig, E; Naber, KG, 1986)		0.27
" The concentration of IPM in plasma showed a dose-response to the 10 mg/10 mg/kg and 20 mg/20 mg/kg dosages."( [Pharmacokinetic, bacteriological and clinical studies on imipenem/cilastatin sodium in neonates].
Iwai, N; Kasai, K; Miyazu, M; Nakamura, H; Taneda, Y, 1989)		0.28
" There was an association with Pseudomonas aeruginosa infection that remained statistically significant even after controlling for imipenem/cilastatin dosage as well as for the other factors indicated."( Factors predisposing to seizures in seriously ill infected patients receiving antibiotics: experience with imipenem/cilastatin.
Calandra, G; Carrigan, J; Guess, H; Lydick, E; Weiss, L, 1988)		0.27
"The chemistry, antimicrobial spectrum, mechanism of action, pharmacology and pharmacokinetics, clinical use, adverse effects, dosage and administration, place in therapy, cost-effectiveness, and formulary considerations of imipenem-cilastatin sodium are reviewed."( Imipenem-cilastatin sodium, a broad-spectrum carbapenem antibiotic combination.
Pastel, DA, 1986)		0.27
" Imipenem and cilastatin sodium in a dosage of 100 mg/kg/d was used for children 3 years of age or younger, while older ones received 60 mg/kg/d intravenously, divided in four equal doses."( Imipenem and cilastatin in acute osteomyelitis and suppurative arthritis. Therapy in infants and children.
Freij, BJ; Kusmiesz, H; Nelson, JD; Shelton, S, 1987)		0.27
" Because patients undergoing continuous haemofiltration have impaired renal function, dosage reduction is often recommended so that adverse drug reactions are avoided."( Clinical pharmacokinetics during continuous haemofiltration.
Bressolle, F; de la Coussaye, JE; Eledjam, JJ; Galtier, M; Kinowski, JM; Wynn, N, 1994)		0.29
" At the dosage used piperacillin/tazobactam was as safe as, and statistically more effective than, imipenem/cilastatin in the treatment of intra-abdominal infections caused by sensitive organisms."( A randomized multicenter trial of piperacillin/tazobactam versus imipenem/cilastatin in the treatment of severe intra-abdominal infections. Swedish Study Group.
Eklund, AE; Nord, CE, 1993)		0.29
" Current dosing recommendations for the administration of imipenem to patients with acute or chronic renal failure are based on this reduced clearance rate."( Comparison of imipenem pharmacokinetics in patients with acute or chronic renal failure treated with continuous hemofiltration.
Macias, WL; Mueller, BA; Scarim, SK, 1993)		0.29
"To develop computerized methods to monitor and recommend dosage changes for patients treated with excessive dosages of imipenem/cilastatin (I/C) and to determine the incidence of I/C-associated seizures in our patient population."( Prospective surveillance of imipenem/cilastatin use and associated seizures using a hospital information system.
Burke, JP; Classen, DC; Evans, RS; Pestotnik, SL; Stevens, LE, 1993)		0.29
" Additional computer-generated alerts identified patients who were receiving anticonvulsants concomitantly with I/C or whose therapy reflected dosage changes in the previous 24 hours."( Prospective surveillance of imipenem/cilastatin use and associated seizures using a hospital information system.
Burke, JP; Classen, DC; Evans, RS; Pestotnik, SL; Stevens, LE, 1993)		0.29
" We believe that appropriate dosing of I/C results in a low rate of associated seizures."( Prospective surveillance of imipenem/cilastatin use and associated seizures using a hospital information system.
Burke, JP; Classen, DC; Evans, RS; Pestotnik, SL; Stevens, LE, 1993)		0.29
"In a nonblind, randomised, parallel-group study, initial empirical monotherapy with meropenem 1 g intravenously every 8 h was compared to an identical dosage of imipenem/cilastatin for the treatment of 66 febrile episodes in 61 adult neutropenic patients."( Empirical monotherapy with meropenem versus imipenem/cilastatin for febrile episodes in neutropenic patients.
Böhme, A; Fuhr, HG; Halir, S; Heller, A; Jung, B; Köhler, A; Lips-Schulte, C; Schaumann, R; Shah, PM; Stille, W; Walther, F, )		0.13
" Plasma and hemofiltrate samples were taken at specified times during one dosing interval, and the concentrations of imipenem and cilastatin were determined by high-performance liquid chromatography."( Pharmacokinetics of imipenem-cilastatin in critically ill patients undergoing continuous venovenous hemofiltration.
Bremer, F; Brune, K; Geisslinger, G; Oelkers, R; Schobel, H; Schüttler, J; Tegeder, I, 1997)		0.3
" The same dosage regimen resulted in complete bacterial eradication in 88% of the kidneys."( Comparative therapeutic efficacy of clinafloxacin in a Pseudomonas aeruginosa mouse renal abscess model.
Desaty, TM; Griffin, TJ; Heifetz, CL; Sesnie, JC; Shapiro, MA, 1998)		0.3
"Tazobactam/piperacillin (total daily dosage of 13."( Cost efficacy of tazobactam/piperacillin versus imipenem/cilastatin in the treatment of intra-abdominal infection.
Daschner, F; Dietrich, ES; Ebner, W; Schubert, B, 2001)		0.31
" In addition, concurrent dosing of BPAA (1 microgram/body) did not reduce the convulsion-inducing dose of PZFX mesilate."( [Drug interactions between nonsteroidal anti-inflammatory drug and pazufloxacin mesilate, a new quinolone antibacterial agent for intravenous use: convulsions in mice after intravenous or intracerebroventricular administration].
Fukuda, H; Kawamura, Y, 2002)		0.31
") infusion at an imipenem dosage of 10 mg/kg (study 1) and 20 mg/kg (study 2)."( Pharmacokinetics of imipenem-cilastatin following intravenous administration in healthy adult horses.
Benson, CE; Boston, RC; Engiles, J; Moate, PJ; Norman, T; Orsini, JA; Poppenga, R, 2005)		0.33
"When dosed appropriately, imipenem/cilastatin may be used to treat serious infections in critically ill patients with central nervous system (CNS) disorders or injury with minimal seizure risk."( Safety of imipenem/cilastatin in neurocritical care patients.
Brophy, GM; Hoffman, J; Trimble, J, 2009)		0.35
" Sixty-four patients underwent the imipenem-cilastatin intramuscular test dosing and none of them had a clinical reaction."( Cross-reactivity and tolerability of imipenem in patients with delayed-type, cell-mediated hypersensitivity to beta-lactams.
Altomonte, G; Buonomo, A; Decinti, M; Lombardo, C; Nucera, E; Pascolini, L; Patriarca, G; Schiavino, D, 2009)		0.35
"To compare clinical outcomes of patients receiving an alternative dosage of meropenem with those of patients receiving imipenem-cilastatin or the traditional dosage of meropenem after failure of or intolerance to cefepime for treatment of febrile neutropenia."( Assessment of an alternative meropenem dosing strategy compared with imipenem-cilastatin or traditional meropenem dosing after cefepime failure or intolerance in adults with neutropenic fever.
Arnold, HM; Augustin, KM; Casabar, E; Dubberke, ER; Hladnik, LM; McKinnon, PS; Reichley, RM; Ritchie, DJ; Westervelt, P, 2009)		0.35
"Of the 127 patients, 40 received imipenem-cilastatin 500 mg every 6 hours between September 1, 2005, and August 31, 2006; 87 patients received meropenem between September 1, 2006, and August 31, 2007: 29 received a traditional dosage of meropenem 1 g every 8 hours, and 58 received an alternative dosage of meropenem 500 mg every 6 hours."( Assessment of an alternative meropenem dosing strategy compared with imipenem-cilastatin or traditional meropenem dosing after cefepime failure or intolerance in adults with neutropenic fever.
Arnold, HM; Augustin, KM; Casabar, E; Dubberke, ER; Hladnik, LM; McKinnon, PS; Reichley, RM; Ritchie, DJ; Westervelt, P, 2009)		0.35
"The alternative meropenem dosage of 500 mg every 6 hours yielded similar patient outcomes, including time to defervescence, need for additional antibiotics, duration of therapy, and mortality, when compared with the traditional meropenem dosage and imipenem-cilastatin in adults with febrile neutropenia."( Assessment of an alternative meropenem dosing strategy compared with imipenem-cilastatin or traditional meropenem dosing after cefepime failure or intolerance in adults with neutropenic fever.
Arnold, HM; Augustin, KM; Casabar, E; Dubberke, ER; Hladnik, LM; McKinnon, PS; Reichley, RM; Ritchie, DJ; Westervelt, P, 2009)		0.35
" Monte Carlo simulations using various dosage regimens at steady-state and 30-min and 3-h infusion rates were performed to evaluate the probabilities of attaining 20% (bacteriostatic), 30%, and 40% (maximum kill) time above the MIC."( Comparison of 30-min and 3-h infusion regimens for imipenem/cilastatin and for meropenem evaluated by Monte Carlo simulation.
Bertino, JS; Drusano, GL; Jones, RN; Kinzig-Schippers, M; Lee, LS; Ma, L; Nafziger, AN; Sörgel, F, 2010)		0.36
" Imipenem would be predicted to be effective for the treatment of antimicrobial resistant bacterial infections in cats at a dosage of 5 mg/kg every 6-8 h (IV, IM), or longer for the SC route."( Pharmacokinetics of imipenem after intravenous, intramuscular and subcutaneous administration to cats.
Albarellos, GA; Denamiel, GA; Landoni, MF; Lupi, MP; Montoya, L; Quaine, PC, 2013)		0.39
" Data including the dosage and duration of the drug use, occurrence of seizures and mortality outcome was collected from the electronic pharmacy records."( A Retrospective Study on the Incidence of Seizures among Neurosurgical Patients Who Treated with Imipenem/Cilastatin or Meropenem.
Chen, K; Shi, Z; Wang, Q; Wu, Y, 2014)		0.4
" There was not further risk for patients with pre-existing seizures or creatinine clearance abnormalities when dosed appropriate."( A Retrospective Study on the Incidence of Seizures among Neurosurgical Patients Who Treated with Imipenem/Cilastatin or Meropenem.
Chen, K; Shi, Z; Wang, Q; Wu, Y, 2014)		0.4
" Therapeutic drug monitoring (TDM) may aid antibiotic prescription and implementation of initial empirical antimicrobial dosage recommendations."( Impact of the introduction of real-time therapeutic drug monitoring on empirical doses of carbapenems in critically ill burn patients.
Decosterd, LA; Eggimann, P; Fournier, A; Marchetti, O; Pagani, JL; Pannatier, A; Que, YA; Revelly, JP; Voirol, P, 2015)		0.42
"Imipenem/cilastatin and meropenem use and daily empirical dosage at a five-bed burn ICU were analyzed retrospectively."( Impact of the introduction of real-time therapeutic drug monitoring on empirical doses of carbapenems in critically ill burn patients.
Decosterd, LA; Eggimann, P; Fournier, A; Marchetti, O; Pagani, JL; Pannatier, A; Que, YA; Revelly, JP; Voirol, P, 2015)		0.42
"Real-time carbapenem TDM availability significantly altered the empirical daily dosage of imipenem/cilastatin at our burn ICU."( Impact of the introduction of real-time therapeutic drug monitoring on empirical doses of carbapenems in critically ill burn patients.
Decosterd, LA; Eggimann, P; Fournier, A; Marchetti, O; Pagani, JL; Pannatier, A; Que, YA; Revelly, JP; Voirol, P, 2015)		0.42
" The significance of using drug combination is that it can reduce drug dosage requirements, reduce the toxic effects of agents and prevent or delay the emergence of drug resistance."( In vitro interactions of ambroxol hydrochloride or amlodipine in combination with antibacterial agents against carbapenem-resistant Acinetobacter baumannii.
Li, X; Lu, C; Sun, S; Wang, D; Wang, Y, 2020)		0.56
" Hence, there is a strong rationale to individualize anti-infective dosing in these patients by using therapeutic drug monitoring (TDM)."( Determination of Total and Unbound Meropenem, Imipenem/Cilastatin, and Cefoperazone/Sulbactam in Human Plasma: Application for Therapeutic Drug Monitoring in Critically Ill Patients.
Dang, ZL; Li, B; Qin, HY; Rao, Z; Wei, YH; Wu, XA; Zhu, L, 2020)		0.56
"This phase 3, multicenter, open-label, noncomparative study (NCT03293485) evaluated relebactam/imipenem/cilastatin (250 mg/500 mg/500 mg) dosed every 6 h for 5-14 days in Japanese patients with complicated intra-abdominal infections (cIAIs) or complicated urinary tract infections (cUTIs), including those with secondary sepsis."( The safety and efficacy of relebactam/imipenem/cilastatin in Japanese patients with complicated intra-abdominal infection or complicated urinary tract infection: A multicenter, open-label, noncomparative phase 3 study.
Aoyama, N; Bando, H; Brown, M; Kawahara, K; Kikukawa, H; Kohno, S; Paschke, A; Shirakawa, M; Takase, A; Yoneyama, F, 2021)		0.62
"Antibiotic dosing in critically ill patients is complicated by variations in the pharmacokinetics of antibiotics in this group."( Evaluating the usefulness of the estimated glomerular filtration rate for determination of imipenem dosage in critically ill patients.
Becker, P; Chausse, J; Gous, A; Milne, M; Mitton, B; Paruk, F; Said, M, 2022)		0.72
" Owing to the variability of antibiotic pharmacokinetics in critically ill patients, this task becomes almost impossible when relying on conventional dosing guidelines."( Evaluating the usefulness of the estimated glomerular filtration rate for determination of imipenem dosage in critically ill patients.
Becker, P; Chausse, J; Gous, A; Milne, M; Mitton, B; Paruk, F; Said, M, 2022)		0.72
[information is derived through text-mining from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Bioassays (19)

Assay IDTitleYearJournalArticle
AID1079948Times to onset, minimal and maximal, observed in the indexed observations. [column 'DELAI' in source]
AID1079936Choleostatic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is < 2 (see ACUTE). Value is number of references indexed. [column 'CHOLE' in source]
AID1079939Cirrhosis, proven histopathologically. Value is number of references indexed. [column 'CIRRH' in source]
AID1079933Acute liver toxicity defined via clinical observations and clear clinical-chemistry results: serum ALT or AST activity > 6 N or serum alkaline phosphatases activity > 1.7 N. This category includes cytolytic, choleostatic and mixed liver toxicity. Value is
AID1079931Moderate liver toxicity, defined via clinical-chemistry results: ALT or AST serum activity 6 times the normal upper limit (N) or alkaline phosphatase serum activity of 1.7 N. Value is number of references indexed. [column 'BIOL' in source]
AID1079942Steatosis, proven histopathologically. Value is number of references indexed. [column 'STEAT' in source]
AID1079947Comments (NB not yet translated). [column 'COMMENTAIRES' in source]
AID1079937Severe hepatitis, defined as possibly life-threatening liver failure or through clinical observations. Value is number of references indexed. [column 'MASS' in source]
AID1079941Liver damage due to vascular disease: peliosis hepatitis, hepatic veno-occlusive disease, Budd-Chiari syndrome. Value is number of references indexed. [column 'VASC' in source]
AID1079932Highest frequency of moderate liver toxicity observed during clinical trials, expressed as a percentage. [column '% BIOL' in source]
AID1079934Highest frequency of acute liver toxicity observed during clinical trials, expressed as a percentage. [column '% AIGUE' in source]
AID1079944Benign tumor, proven histopathologically. Value is number of references indexed. [column 'T.BEN' in source]
AID1079935Cytolytic liver toxicity, either proven histopathologically or where the ratio of maximal ALT or AST activity above normal to that of Alkaline Phosphatase is > 5 (see ACUTE). Value is number of references indexed. [column 'CYTOL' in source]
AID1079945Animal toxicity known. [column 'TOXIC' in source]
AID1079943Malignant tumor, proven histopathologically. Value is number of references indexed. [column 'T.MAL' in source]
AID1079946Presence of at least one case with successful reintroduction. [column 'REINT' in source]
AID1079940Granulomatous liver disease, proven histopathologically. Value is number of references indexed. [column 'GRAN' in source]
AID1079949Proposed mechanism(s) of liver damage. [column 'MEC' in source]
AID1079938Chronic liver disease either proven histopathologically, or through a chonic elevation of serum amino-transferase activity after 6 months. Value is number of references indexed. [column 'CHRON' in source]
[information is prepared from bioassay data collected from National Library of Medicine (NLM), extracted Dec-2023]

Research

Studies (440)

TimeframeStudies, This Drug (%)All Drugs %
pre-199079 (17.95)18.7374
1990's148 (33.64)18.2507
2000's88 (20.00)29.6817
2010's86 (19.55)24.3611
2020's39 (8.86)2.80
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Market Indicators

Research Demand Index: 8.28

According to the monthly volume, diversity, and competition of internet searches for this compound, as well the volume and growth of publications, there is estimated to be weak demand-to-supply ratio for research on this compound.

MetricThis Compound (vs All)
Research Demand Index8.28 (24.57)
Research Supply Index6.40 (2.92)
Research Growth Index4.68 (4.65)
Search Engine Demand Index0.00 (26.88)
Search Engine Supply Index0.00 (0.95)

This Compound (8.28)

All Compounds (24.57)

Study Types

Publication TypeThis drug (%)All Drugs (%)
Trials130 (27.48%)5.53%
Reviews30 (6.34%)6.00%
Case Studies97 (20.51%)4.05%
Observational3 (0.63%)0.25%
Other213 (45.03%)84.16%
[information is prepared from research data collected from National Library of Medicine (NLM), extracted Dec-2023]

Clinical Trials (14)

Trial Overview

TrialPhaseEnrollmentStudy TypeStart DateStatus
A Phase III Non-randomized, Non-controlled, Open Label Clinical Trial to Study the Safety and Efficacy of Imipenem/Cilastatin/Relebactam (IMI/REL [MK-7655A]) in Japanese Subjects With Complicated Intra-Abdominal Infection (cIAI) or Complicated Urinary Tra [NCT03293485]Phase 383 participants (Actual)Interventional2017-10-04Completed
Prospective Randomized Study to Compare Clinical Outcomes in Patients With Osteomyelitis Treated With Intravenous Antibiotics Versus Intravenous Antibiotics With an Early Switch to Oral Antibiotics [NCT02099240]Early Phase 111 participants (Actual)Interventional2014-03-06Terminated(stopped due to Not enough patient enrollment and lack of staffing)
A Multi-center, Randomized, Double-blind, Active Controlled, Parallel Groups, Phase II Study to Evaluate the Efficacy and Safety of Intravenous HRS-8427 in the Treatment of Adults With Complicate Urinary Tract Infection, Including Acute Pyelonephritis [NCT06144060]Phase 2126 participants (Anticipated)Interventional2023-12-31Not yet recruiting
Short Versus Extended Antibiotic Treatment With a Carbapenem for High-risk Febrile Neutropenia in Hematology Patients With Fever of Unknown Origin: a Randomized Multicenter Non-inferiority Trial. [NCT02149329]Phase 4276 participants (Actual)Interventional2014-12-31Completed
A Multicenter, Randomized, Double Blind, Comparative Trial of Intravenous MERREM (Meropenem, ICI 194,660) vs PRIMAXIN I.V. (Imipenem-cilastatin) in the Treatment of Hospitalised Subjects With Complicated Skin and Skin Structure Infections. [NCT00619710]Phase 31,000 participants (Anticipated)Interventional2001-02-28Completed
A Prospective, Randomized, Double-Blind, Double-Dummy, Multicenter Study to Assess the Safety and Efficacy of Doripenem Compared With Imipenem-Cilastatin in the Treatment of Subjects With Ventilator-Associated Pneumonia [NCT00589693]Phase 3274 participants (Actual)Interventional2008-04-30Terminated(stopped due to Observed lower cure rates and higher mortality rates in one of the treatment groups.)
A De-Escalating Strategy for Antibiotic Treatment of Pneumonia in The Medical Intensive Care Unit [NCT00445094]Phase 4120 participants (Actual)Interventional2006-11-30Completed
Imipenem Prophylaxis of Infectious Complications in Patients With Acute Pancreatitis [NCT02897206]Phase 498 participants (Actual)Interventional2014-10-31Completed
A Phase III, Randomized, Double-Blind, Active Comparator-Controlled Clinical Trial to Estimate the Efficacy and Safety of Imipenem/Cilastatin/Relebactam (MK-7655A) Versus Colistimethate Sodium + Imipenem/Cilastatin in Subjects With Imipenem-Resistant Bact [NCT02452047]Phase 350 participants (Actual)Interventional2015-08-21Completed
A Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety and Efficacy of Intravenous Sulbactam-ETX2514 in the Treatment of Hospitalized Adults With Complicated Urinary Tract Infections, Including Acute Pyelonephritis [NCT03445195]Phase 280 participants (Actual)Interventional2018-01-17Completed
A Randomised, Double-blind, Dose-finding, Multicenter Study of the Safety, Tolerability, and Efficacy of GSK2251052 Therapy Compared to Imipenem-cilastatin in the Treatment of Adult Subjects With Febrile Complicated Lower Urinary Tract Infections and Acut [NCT01381549]Phase 220 participants (Actual)Interventional2011-06-28Terminated(stopped due to Microbiological findings of resistance on therapy in patients with complicated urinary tract infection)
Efficacy and Safety of Colistin Based Antibiotic Therapy for Multidrug Resistant Gram Negative Infections in Pediatric Intensive Care Unit [NCT04764058]Phase 1/Phase 260 participants (Actual)Interventional2017-09-01Enrolling by invitation
A Phase 3, Randomized, Double-blind, Double-dummy, Multicenter, Multinational Study to Assess the Efficacy and Safety of Orally Administered Tebipenem Pivoxil Hydrobromide (TBP-PI-HBr) Compared to Intravenously Administered Imipenem-cilastatin in Patients [NCT06059846]Phase 32,648 participants (Anticipated)Interventional2023-11-30Not yet recruiting
A Single-Dose Study to Investigate the Pharmacokinetics of MK-7655 in Subjects With Impaired Renal Function [NCT01275170]Phase 149 participants (Actual)Interventional2011-01-28Completed
[information is prepared from clinicaltrials.gov, extracted Sep-2024]

Trial Outcomes

TrialOutcome
NCT00589693 (5) [back to overview]28-day All-cause Mortality Rate
NCT00589693 (5) [back to overview]Clinical Cure Rate at the End-of-treatment (EOT) Visit
NCT00589693 (5) [back to overview]Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline
NCT00589693 (5) [back to overview]Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline
NCT00589693 (5) [back to overview]Number of Patients Who Had Emergence of P. Aeruginosa Resistance
NCT01275170 (27) [back to overview]Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD)
NCT01275170 (27) [back to overview]Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD)
NCT01275170 (27) [back to overview]Parts 1 and 2: Percentage of Participants With ≥1 Adverse Events (AEs)
NCT01275170 (27) [back to overview]Part 2: Plasma AUC0-∞ of Omeprazole as a Probe Substrate of Cytochrome P450 Enzyme (CYP)2C19
NCT01275170 (27) [back to overview]Part 2: Plasma AUC0-∞ of Midazolam as a Probe Substrate of Cytochrome P450 Enzyme (CYP)3A4
NCT01275170 (27) [back to overview]Part 2: Plasma AUC0-∞ of Caffeine as a Probe Substrate of Cytochrome P450 Enzyme (CYP)1A2
NCT01275170 (27) [back to overview]Part 1: Renal Clearance (CLR) of MK-7655 in Urine
NCT01275170 (27) [back to overview]Part 1: VZpred of Imipenem in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: VZpred of Cilastin in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Tmax of Imipenem in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Tmax of Cilastin in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Time of Maximum Plasma Concentration (Tmax) of MK-7655 in Combination With PRIMAXIN®
NCT01275170 (27) [back to overview]Part 1: Predicted Volume of Distribution During the Terminal Phase (VZpred) of MK-7655 in Combination With PRIMAXIN®
NCT01275170 (27) [back to overview]Part 1: Predicted Clearance (CLpred) of MK-7655 in Combination With PRIMAXIN®
NCT01275170 (27) [back to overview]Part 1: Concentration at End of Infusion (Ceoi) of MK-7655 in Combination With PRIMAXIN®
NCT01275170 (27) [back to overview]Part 1: CLR of Imipenem in Urine
NCT01275170 (27) [back to overview]Part 1: CLR of Cilastin in Urine
NCT01275170 (27) [back to overview]Part 1: CLpred of Imipenem in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: CLpred of Cilastin in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Ceoi of Imipenem in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Ceoi of Cilastin in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: AUC0-inf of Imipenem in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: AUC0-inf of Cilastin in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Area Under the Plasma Concentration-time Curve From Dosing to Infinity (AUC0-inf) of MK-7655 in Combination With PRIMAXIN®
NCT01275170 (27) [back to overview]Part 1: Apparent t½ of Imipenem in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Apparent t½ of Cilastin in Combination With MK-7655
NCT01275170 (27) [back to overview]Part 1: Apparent Plasma Half-life (t½) of MK-7655 in Combination With PRIMAXIN®
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin
NCT01381549 (34) [back to overview]Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin
NCT01381549 (34) [back to overview]Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)
NCT01381549 (34) [back to overview]Change From Baseline in Hematology Parameters- Hematocrit
NCT01381549 (34) [back to overview]Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)
NCT01381549 (34) [back to overview]Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)
NCT01381549 (34) [back to overview]Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)
NCT01381549 (34) [back to overview]Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes
NCT01381549 (34) [back to overview]Number of Participants With Abnormal Electrocardiogram (ECG) Findings
NCT01381549 (34) [back to overview]Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Heart Rate
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Heart Rate
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Heart Rate
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Respiration Rate
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Respiration Rate
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Respiration Rate
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Temperature
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Temperature
NCT01381549 (34) [back to overview]Summary of Vital Signs- Mean Temperature
NCT01381549 (34) [back to overview]Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT01381549 (34) [back to overview]Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT01381549 (34) [back to overview]Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)
NCT01381549 (34) [back to overview]Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit
NCT01381549 (34) [back to overview]Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit
NCT01381549 (34) [back to overview]Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit
NCT02452047 (18) [back to overview]Percentage of Participants With ≥1 Events of Clinical Interest (ECI)
NCT02452047 (18) [back to overview]Analysis of Specific AEs With an Incidence of ≥4 Participants in a Treatment Group
NCT02452047 (18) [back to overview]Percentage of Participants With FCR on Therapy (OTX)
NCT02452047 (18) [back to overview]Percentage of Participants With FCR at End of Therapy (EOT)
NCT02452047 (18) [back to overview]Percentage of Participants With FCR at EFU
NCT02452047 (18) [back to overview]Percentage of Participants With Favorable Overall Response (FOR)
NCT02452047 (18) [back to overview]Percentage of Participants With All-cause Mortality Up to Day 28
NCT02452047 (18) [back to overview]Percentage of Participants With ≥1 Serious Adverse Events (SAEs)
NCT02452047 (18) [back to overview]Percentage of Participants With ≥1 Events of Treatment-Emergent Nephrotoxicity
NCT02452047 (18) [back to overview]Percentage of Participants With ≥1 Drug-Related SAEs
NCT02452047 (18) [back to overview]Percentage of Participants With ≥1 Drug-Related AEs
NCT02452047 (18) [back to overview]Percentage of Participants With Favorable Clinical Response (FCR) at Day 28
NCT02452047 (18) [back to overview]Percentage of Participants With ≥1 Adverse Events (AEs)
NCT02452047 (18) [back to overview]Percentage of Participants Discontinuing From Study Therapy Due to ≥1 Drug-Related AEs
NCT02452047 (18) [back to overview]Percentage of Participants Discontinuing From Study Therapy Due to ≥1 AEs
NCT02452047 (18) [back to overview]Percentage of cUTI Participants With FMR at EOT
NCT02452047 (18) [back to overview]Percentage of cUTI Participants With FMR at EFU
NCT02452047 (18) [back to overview]Percentage of cUTI Participants With Favorable Microbiological Response (FMR) at OTX
NCT03293485 (6) [back to overview]Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit
NCT03293485 (6) [back to overview]Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)
NCT03293485 (6) [back to overview]Percentage of Participants Experiencing ≥1 Adverse Events (AE)
NCT03293485 (6) [back to overview]Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit
NCT03293485 (6) [back to overview]Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit
NCT03293485 (6) [back to overview]Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit
NCT03445195 (3) [back to overview]Microbiologic Eradication
NCT03445195 (3) [back to overview]Clinical Cure
NCT03445195 (3) [back to overview]Number of Participants With Overall Success

28-day All-cause Mortality Rate

Number of deaths which occured up to 28 days of the study period due to all causes (NCT00589693)
Timeframe: Up to 28 days

InterventionParticipants (Number)
Doripenem17
Imipenem-cilastatin13

[back to top]

Clinical Cure Rate at the End-of-treatment (EOT) Visit

The number of patients who achieved clinical cure at the EOT visit on Day 10. The patient's were classified as clinical cure if they had resolution of signs and symptoms and objective findings of pneumonia to such an extent that no further antimicrobial therapy was necessary. (NCT00589693)
Timeframe: End-of-treatment (Day 10 or Day 11)

InterventionParticipants (Number)
Doripenem36
Imipenem-cilastatin50

[back to top]

Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom a Qualifying P. Aeruginosa Was Isolated at Baseline

The clinical cure rate at the EOT visit in patients, whose bronchoalveolar lavage (BAL) or mini-BAL culture results yielded qualifying pneumonia pathogen P. aeruginosa at baseline. (NCT00589693)
Timeframe: End-of-treatment (Day 10 or Day 11)

InterventionParticipants (Number)
Doripenem7
Imipenem-cilastatin6

[back to top]

Clinical Cure Rate at the End-of-treatment (EOT) Visit in Patients From Whom at Least 1 of the Gram-negative Qualifying Pneumonia Pathogens (Enterobacteriaceae, P. Aeruginosa, and Acinetobacter Spp) Was Isolated at Baseline

The clinical cure rate at the EOT visit in patients whose BAL or mini-BAL culture results yielded at least 1 of the following Gram-negative qualifying pneumonia pathogens was isolated at baseline: any Enterobacteriaceae, P. aeruginosa, and Acinetobacter Spp. (NCT00589693)
Timeframe: End-of-treatment (Day 10 or Day 11)

InterventionParticipants (Number)
Doripenem32
Imipenem-cilastatin34

[back to top]

Number of Patients Who Had Emergence of P. Aeruginosa Resistance

Number of patients who had P. aeruginosa isolates with a 4 fold or greater increase in minimum inhibitory concentration (MIC) at anytime during the study (after the study medication is received) from baseline (NCT00589693)
Timeframe: Up to 6 weeks

InterventionParticipants (Number)
Doripenem3
Imipenem-cilastatin6

[back to top]

Extraction Coefficient of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD)

The extraction coefficient of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating extraction coefficient was: Extraction Coefficient = ABS[100*(post-dialyzer concentration - pre-dialyzer concentration) / pre-dialyzer concentration]. (NCT01275170)
Timeframe: 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours postdose

InterventionExtraction coefficient (Geometric Mean)
1 hour postdose1.5 hours postdose2 hours postdose2.5 hours postdose3.0 hours postdose3.5 hours postdose4 hours postdose4.5 hours postdose
Panel G: ESRD/HD Period 2 Predialysis7367737173768784

[back to top]

Dialysis Clearance (CLD) of MK-7655 in Participants With End-stage Renal Diseases Requiring Hemodialysis (ESRD/HD)

The CLD of MK-7655 was determined in ESRD/HD participants for 4.5 hours during HD. The formula for calculating CLD was: CLd = (1-Hct)*QB*[(pre-dialyzer concentration - post-dialyzer concentration) / (pre-dialyzer concentration)] where QB=350 mL/min and Hct=hematocrit. (NCT01275170)
Timeframe: 1, 1.5, 2, 2.5, 3, 3.5, 4, and 4.5 hours postdose

InterventionmL/min (Geometric Mean)
1 hour postdose1.5 hours postdose2 hours postdose2.5 hours postdose3.0 hours postdose3.5 hours postdose4 hours postdose4.5 hours postdose
Panel G: ESRD/HD Period 2 Predialysis172158170166171177204198

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Parts 1 and 2: Percentage of Participants With ≥1 Adverse Events (AEs)

An AE is defined as any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with this treatment. (NCT01275170)
Timeframe: Up to 14 days after the last dose of study drug in Part 2 (up to 11 weeks)

InterventionPercentage of Participants (Number)
Panel A: Mild Renal Impairment28.6
Panel C: Moderate Renal Impairment16.7
Panel E: Severe Renal Impairment16.7
Panel G: ESRD/HD Participants33.3
Healthy Matched Controls (Part 1)0.0
Panel E: Severe Renal Impairment (Part 2)33.3
Panel G: ESRD/HD (Part 2)33.3
Healthy Matched Controls (Part 2)0.0

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Part 2: Plasma AUC0-∞ of Omeprazole as a Probe Substrate of Cytochrome P450 Enzyme (CYP)2C19

Omeprazole was selected as a substrate of CYP2C19. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants. (NCT01275170)
Timeframe: Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose

InterventionµM*hr (Geometric Mean)
Panel E: Severe Renal Impairment9.10
Panel F: Healthy Controls to Panel E6.20
Panel G: ESRD/HD Period 1 Postdialysis4.56
Panel G: ESRD/HD Period 2 Predialysis4.08
Panel H: Healthy Controls to Panel G5.03

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Part 2: Plasma AUC0-∞ of Midazolam as a Probe Substrate of Cytochrome P450 Enzyme (CYP)3A4

Midazolam was selected as a substrate of CYP3A4. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants. (NCT01275170)
Timeframe: Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose

InterventionµM*hr (Geometric Mean)
Panel E: Severe Renal Impairment0.130
Panel F: Healthy Controls to Panel E0.121
Panel G: ESRD/HD Period 1 Postdialysis0.0681
Panel G: ESRD/HD Period 2 Predialysis0.0700
Panel H: Healthy Controls to Panel G0.114

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Part 2: Plasma AUC0-∞ of Caffeine as a Probe Substrate of Cytochrome P450 Enzyme (CYP)1A2

Caffeine was selected as a substrate of CYP1A2. AUC0-∞ was determined in participants with severe renal impairment and ESRD/HD participants. (NCT01275170)
Timeframe: Predose and 0.5, 1, 2,3, 4, 8, 12, and 24 hours postdose

InterventionµM*hr (Geometric Mean)
Panel E: Severe Renal Impairment336
Panel F: Healthy Controls to Panel E221
Panel G: ESRD/HD Period 1 Postdialysis190
Panel G: ESRD/HD Period 2 Predialysis200
Panel H: Healthy Controls to Panel G300

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Part 1: Renal Clearance (CLR) of MK-7655 in Urine

CLR represents renal clearance in urine. Urine was collected for 24 hours postdose. (NCT01275170)
Timeframe: Predose to 24 hours postdose

InterventionmL/min (Geometric Mean)
Panel A: Mild Renal Impairment69.8
Panel B: Healthy Controls to Panel A118
Panel C: Moderate Renal Impairment38.4
Panel D: Healthy Controls to Panel C110
Panel E: Severe Renal Impairment22.3
Panel F: Healthy Controls to Panel E107
Panel H: Healthy Controls to Panel G110

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Part 1: VZpred of Imipenem in Combination With MK-7655

Imipenem is 1 of the 2 constituents of PRIMAXIN®. VZpred is the predicted volume of distribution during the terminal phase. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionliters (L) (Geometric Mean)
Panel A: Mild Renal Impairment21.1
Panel B: Healthy Controls to Panel A26.1
Panel C: Moderate Renal Impairment22.3
Panel D: Healthy Controls to Panel C23.4
Panel E: Severe Renal Impairment20.0
Panel F: Healthy Controls to Panel E24.8
Panel G: ESRD/HD Period 1 Postdialysis20.5
Panel H: Healthy Controls to Panel G24.9
Panel G: ESRD/HD Period 2 Predialysis63.3

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Part 1: VZpred of Cilastin in Combination With MK-7655

Cilastin is 1 of the 2 constituents of PRIMAXIN®. VZpred is the predicted volume of distribution during the terminal phase. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionliters (L) (Geometric Mean)
Panel A: Mild Renal Impairment19.2
Panel B: Healthy Controls to Panel A23.9
Panel C: Moderate Renal Impairment19.4
Panel D: Healthy Controls to Panel C21.4
Panel E: Severe Renal Impairment16.9
Panel F: Healthy Controls to Panel E21.2
Panel G: ESRD/HD Period 1 Postdialysis15.9
Panel H: Healthy Controls to Panel G21.0
Panel G: ESRD/HD Period 2 Predialysis59.1

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Part 1: Tmax of Imipenem in Combination With MK-7655

Tmax is the time at which the highest plasma drug concentration was observed. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionhours (Median)
Panel A: Mild Renal Impairment0.50
Panel B: Healthy Controls to Panel A0.50
Panel C: Moderate Renal Impairment0.49
Panel D: Healthy Controls to Panel C0.48
Panel E: Severe Renal Impairment0.48
Panel F: Healthy Controls to Panel E0.48
Panel G: ESRD/HD Period 1 Postdialysis0.48
Panel H: Healthy Controls to Panel G0.48
Panel G: ESRD/HD Period 2 Predialysis0.48

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Part 1: Tmax of Cilastin in Combination With MK-7655

Tmax is the time at which the highest plasma drug concentration was observed. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionhours (Median)
Panel A: Mild Renal Impairment0.50
Panel B: Healthy Controls to Panel A0.50
Panel C: Moderate Renal Impairment0.49
Panel D: Healthy Controls to Panel C0.48
Panel E: Severe Renal Impairment0.48
Panel F: Healthy Controls to Panel E0.48
Panel G: ESRD/HD Period 1 Postdialysis0.48
Panel H: Healthy Controls to Panel G0.48
Panel G: ESRD/HD Period 2 Predialysis0.48

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Part 1: Time of Maximum Plasma Concentration (Tmax) of MK-7655 in Combination With PRIMAXIN®

Tmax is the time at which the highest plasma drug concentration was observed. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionhours (Median)
Panel A: Mild Renal Impairment0.50
Panel B: Healthy Controls to Panel A0.50
Panel C: Moderate Renal Impairment0.50
Panel D: Healthy Controls to Panel C0.49
Panel E: Severe Renal Impairment0.48
Panel F: Healthy Controls to Panel E0.48
Panel G: ESRD/HD Period 1 Postdialysis0.48
Panel H: Healthy Controls to Panel G0.48
Panel G: ESRD/HD Period 2 Predialysis0.48

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Part 1: Predicted Volume of Distribution During the Terminal Phase (VZpred) of MK-7655 in Combination With PRIMAXIN®

VZpred is the predicted volume of distribution during the terminal phase. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionliters (L) (Geometric Mean)
Panel A: Mild Renal Impairment21.4
Panel B: Healthy Controls to Panel A21.6
Panel C: Moderate Renal Impairment22.2
Panel D: Healthy Controls to Panel C21.9
Panel E: Severe Renal Impairment20.1
Panel F: Healthy Controls to Panel E22.4
Panel G: ESRD/HD Period 1 Postdialysis16.2
Panel H: Healthy Controls to Panel G17.0
Panel G: ESRD/HD Period 2 Predialysis55.7

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Part 1: Predicted Clearance (CLpred) of MK-7655 in Combination With PRIMAXIN®

CLpred is the predicted apparent total body clearance of drug. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

InterventionmL/min (Geometric Mean)
Panel A: Mild Renal Impairment81.3
Panel B: Healthy Controls to Panel A133
Panel C: Moderate Renal Impairment52.1
Panel D: Healthy Controls to Panel C114
Panel E: Severe Renal Impairment25.3
Panel F: Healthy Controls to Panel E123
Panel G: ESRD/HD Period 1 Postdialysis14.4
Panel H: Healthy Controls to Panel G135
Panel G: ESRD/HD Period 2 Predialysis76.6

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Part 1: Concentration at End of Infusion (Ceoi) of MK-7655 in Combination With PRIMAXIN®

Ceoi is the observed plasma drug concentration at the end of IV infusion. (NCT01275170)
Timeframe: At 0.5 hours postdose

InterventionµM (Geometric Mean)
Panel A: Mild Renal Impairment22.4
Panel B: Healthy Controls to Panel A20.4
Panel C: Moderate Renal Impairment23.5
Panel D: Healthy Controls to Panel C22.5
Panel E: Severe Renal Impairment23.6
Panel F: Healthy Controls to Panel E18.1
Panel G: ESRD/HD Period 1 Postdialysis53.1
Panel H: Healthy Controls to Panel G22.7
Panel G: ESRD/HD Period 2 Predialysis19.3

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Part 1: CLR of Imipenem in Urine

CLR represents renal clearance in urine. Urine was collected for 24 hours postdose. (NCT01275170)
Timeframe: Predose to 24 hours postdose

InterventionmL/min (Geometric Mean)
Panel A: Mild Renal Impairment75.0
Panel B: Healthy Controls to Panel A115
Panel C: Moderate Renal Impairment41.1
Panel D: Healthy Controls to Panel C109
Panel E: Severe Renal Impairment17.4
Panel F: Healthy Controls to Panel E104
Panel H: Healthy Controls to Panel G99.1

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Part 1: CLR of Cilastin in Urine

CLR represents renal clearance in urine. Urine was collected for 24 hours postdose. (NCT01275170)
Timeframe: Predose to 24 hours postdose

InterventionmL/min (Geometric Mean)
Panel A: Mild Renal Impairment99.4
Panel B: Healthy Controls to Panel A144
Panel C: Moderate Renal Impairment59.6
Panel D: Healthy Controls to Panel C136
Panel E: Severe Renal Impairment24.5
Panel F: Healthy Controls to Panel E140
Panel H: Healthy Controls to Panel G146

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Part 1: CLpred of Imipenem in Combination With MK-7655

Imipenem is 1 of the 2 constituents of PRIMAXIN®. CLpred is the predicted apparent total body clearance of drug. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

InterventionmL/min (Geometric Mean)
Panel A: Mild Renal Impairment180
Panel B: Healthy Controls to Panel A253
Panel C: Moderate Renal Impairment138
Panel D: Healthy Controls to Panel C211
Panel E: Severe Renal Impairment87.0
Panel F: Healthy Controls to Panel E218
Panel G: ESRD/HD Period 1 Postdialysis62.5
Panel H: Healthy Controls to Panel G194
Panel G: ESRD/HD Period 2 Predialysis195

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Part 1: CLpred of Cilastin in Combination With MK-7655

Cilastin is 1 of the 2 constituents of PRIMAXIN®. CLpred is the predicted apparent total body clearance of drug. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

InterventionmL/min (Geometric Mean)
Panel A: Mild Renal Impairment162
Panel B: Healthy Controls to Panel A259
Panel C: Moderate Renal Impairment116
Panel D: Healthy Controls to Panel C217
Panel E: Severe Renal Impairment38.7
Panel F: Healthy Controls to Panel E217
Panel G: ESRD/HD Period 1 Postdialysis15.0
Panel H: Healthy Controls to Panel G206
Panel G: ESRD/HD Period 2 Predialysis56.6

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Part 1: Ceoi of Imipenem in Combination With MK-7655

Imipenem is 1 of the 2 constituents of PRIMAXIN®. Ceoi is the observed plasma drug concentration at the end of IV infusion. (NCT01275170)
Timeframe: At 0.5 hours postdose

InterventionµM (Geometric Mean)
Panel A: Mild Renal Impairment40.7
Panel B: Healthy Controls to Panel A35.3
Panel C: Moderate Renal Impairment45.6
Panel D: Healthy Controls to Panel C42.6
Panel E: Severe Renal Impairment46.9
Panel F: Healthy Controls to Panel E35.5
Panel G: ESRD/HD Period 1 Postdialysis103
Panel H: Healthy Controls to Panel G41.8
Panel G: ESRD/HD Period 2 Predialysis35.9

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Part 1: Ceoi of Cilastin in Combination With MK-7655

Cilastin is 1 of the 2 constituents of PRIMAXIN®. Ceoi is the observed plasma drug concentration at the end of IV infusion. (NCT01275170)
Timeframe: At 0.5 hours postdose

InterventionµM (Geometric Mean)
Panel A: Mild Renal Impairment43.4
Panel B: Healthy Controls to Panel A34.8
Panel C: Moderate Renal Impairment48.7
Panel D: Healthy Controls to Panel C42.9
Panel E: Severe Renal Impairment53.3
Panel F: Healthy Controls to Panel E35.8
Panel G: ESRD/HD Period 1 Postdialysis111
Panel H: Healthy Controls to Panel G44.5
Panel G: ESRD/HD Period 2 Predialysis41.7

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Part 1: AUC0-inf of Imipenem in Combination With MK-7655

Imipenem is 1 of the 2 constituents of PRIMAXIN®. AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

InterventionµM*hr (Geometric Mean)
Panel A: Mild Renal Impairment77.3
Panel B: Healthy Controls to Panel A55.0
Panel C: Moderate Renal Impairment101
Panel D: Healthy Controls to Panel C66.0
Panel E: Severe Renal Impairment160
Panel F: Healthy Controls to Panel E63.8
Panel G: ESRD/HD Period 1 Postdialysis223
Panel H: Healthy Controls to Panel G71.8
Panel G: ESRD/HD Period 2 Predialysis71.2

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Part 1: AUC0-inf of Cilastin in Combination With MK-7655

Cilastin is 1 of the 2 constituents of PRIMAXIN®. AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

InterventionµM*hr (Geometric Mean)
Panel A: Mild Renal Impairment71.7
Panel B: Healthy Controls to Panel A44.8
Panel C: Moderate Renal Impairment100.0
Panel D: Healthy Controls to Panel C53.6
Panel E: Severe Renal Impairment300
Panel F: Healthy Controls to Panel E53.7
Panel G: ESRD/HD Period 1 Postdialysis777
Panel H: Healthy Controls to Panel G56.5
Panel G: ESRD/HD Period 2 Predialysis205

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Part 1: Area Under the Plasma Concentration-time Curve From Dosing to Infinity (AUC0-inf) of MK-7655 in Combination With PRIMAXIN®

AUC0-∞ is a measure of the mean (extrapolated) plasma drug concentration after dosing to infinity. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

InterventionµM*hr (Geometric Mean)
Panel A: Mild Renal Impairment73.5
Panel B: Healthy Controls to Panel A45.0
Panel C: Moderate Renal Impairment115
Panel D: Healthy Controls to Panel C52.3
Panel E: Severe Renal Impairment236
Panel F: Healthy Controls to Panel E48.5
Panel G: ESRD/HD Period 1 Postdialysis414
Panel H: Healthy Controls to Panel G44.5
Panel G: ESRD/HD Period 2 Predialysis78.0

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Part 1: Apparent t½ of Imipenem in Combination With MK-7655

Imipenem is 1 of the 2 constituents of PRIMAXIN®. Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionhours (Geometric Mean)
Panel A: Mild Renal Impairment1.54
Panel B: Healthy Controls to Panel A1.24
Panel C: Moderate Renal Impairment2.18
Panel D: Healthy Controls to Panel C1.40
Panel E: Severe Renal Impairment2.78
Panel F: Healthy Controls to Panel E1.32
Panel G: ESRD/HD Period 1 Postdialysis3.24
Panel H: Healthy Controls to Panel G1.21
Panel G: ESRD/HD Period 2 Predialysis3.20

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Part 1: Apparent t½ of Cilastin in Combination With MK-7655

Cilastin is 1 of the 2 constituents of PRIMAXIN®. Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionhours (Geometric Mean)
Panel A: Mild Renal Impairment1.43
Panel B: Healthy Controls to Panel A1.08
Panel C: Moderate Renal Impairment2.11
Panel D: Healthy Controls to Panel C1.19
Panel E: Severe Renal Impairment5.08
Panel F: Healthy Controls to Panel E1.09
Panel G: ESRD/HD Period 1 Postdialysis12.2
Panel H: Healthy Controls to Panel G1.14
Panel G: ESRD/HD Period 2 Predialysis12.2

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Part 1: Apparent Plasma Half-life (t½) of MK-7655 in Combination With PRIMAXIN®

Apparent t½ is the amount of time for the maximum drug concentration to decrease by 50%. (NCT01275170)
Timeframe: Predose and 0.08, 0.25, 0.5, 0.75, 1, 1.5, 2, 3, 4.5, 6, 8, 10, and 14 hours postdose

Interventionhours (Geometric Mean)
Panel A: Mild Renal Impairment2.63
Panel B: Healthy Controls to Panel A1.75
Panel C: Moderate Renal Impairment4.51
Panel D: Healthy Controls to Panel C2.10
Panel E: Severe Renal Impairment8.65
Panel F: Healthy Controls to Panel E2.00
Panel G: ESRD/HD Period 1 Postdialysis15.6
Panel H: Healthy Controls to Panel G1.79
Panel G: ESRD/HD Period 2 Predialysis10.5

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Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)

Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,
InterventionInternational units per Liter (Mean)
ALT: On IV therapy (Day 3)ALT: On IV therapy (Day 5)ALT: On IV therapy (Day 8)ALT: End of IV therapyALT: Test of CureALT: Early Follow-upALT: Late Follow-upALP: On IV therapy (Day 3)ALP: On IV therapy (Day 5)ALP: On IV therapy (Day 8)ALP: End of IV therapyALP: Test of CureALP: Early Follow-upALP: Late Follow-upAST: On IV therapy (Day 3)AST: On IV therapy (Day 5)AST: On IV therapy (Day 8)AST: End of IV therapyAST: Test of CureAST: Early Follow-upAST: Late Follow-upCreatine kinase : On IV therapy (Day 5)Creatine kinase : End of IV therapyCreatine kinase : Test of CureCreatine kinase : Early Follow-upCreatine kinase : Late Follow-upGGT : On IV therapy (Day 5)GGT : End of IV therapyGGT : Test of CureGGT : Early Follow-upGGT : Late Follow-up
GSK2251052 1500 mg10.44.81.518.67.31.0-0.314.34.021.516.36.91.22.34.16.32.013.1-2.3-4.8-3.3-37.8-165.6-156.4-218.2-168.86.528.923.38.31.3
Imipenem-Cilastatin12.813.3-3.021.37.05.84.213.217.7-10.010.214.88.23.619.220.02.015.7-1.41.23.4-26.0-23.718.4-6.00.224.014.03.6-0.8-3.8

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Change From Baseline in Clinical Laboratory Parameters- Alanine Amino Transferase (ALT), Alkaline Phosphatase (ALP), Aspartate Amino Transferase (AST), Creatine Kinase and Gamma Glutamyl Transferase (GGT)

Clinical laboratory parameters included ALT, ALP, AST, Creatine kinase and GGT. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in ALT, ALP, AST, Creatine kinase and GGT are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionInternational units per Liter (Mean)
ALT: On IV therapy (Day 3)ALT: On IV therapy (Day 5)ALT: On IV therapy (Day 8)ALT: On IV therapy (Day 11)ALT: End of IV therapyALT: Test of CureALT: Early Follow-upALT: Late Follow-upALP: On IV therapy (Day 3)ALP: On IV therapy (Day 5)ALP: On IV therapy (Day 8)ALP: On IV therapy (Day 11)ALP: End of IV therapyALP: Test of CureALP: Early Follow-upALP: Late Follow-upAST: On IV therapy (Day 3)AST: On IV therapy (Day 5)AST: On IV therapy (Day 8)AST: On IV therapy (Day 11)AST: End of IV therapyAST: Test of CureAST: Early Follow-upAST: Late Follow-upCreatine kinase : On IV therapy (Day 5)Creatine kinase : On IV therapy (Day 11)Creatine kinase : End of IV therapyCreatine kinase : Test of CureCreatine kinase : Early Follow-upCreatine kinase : Late Follow-upGGT : On IV therapy (Day 5)GGT : On IV therapy (Day 11)GGT : End of IV therapyGGT : Test of CureGGT : Early Follow-upGGT : Late Follow-up
GSK2251052 750 mg5.733.24.02.035.417.54.83.310.811.2-10.0-11.07.410.87.45.75.031.5-2.02.022.01.5-1.23.3-76.04.0-36.0-65.3-41.4-37.841.722.035.816.5-1.4-16.7

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Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein

Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,
InterventionGram per Liter (Mean)
Albumin: On IV therapy (Day 5)Albumin: End of IV therapyAlbumin: Test of CureAlbumin: Early Follow-upAlbumin: Late Follow-upTotal protein: On IV therapy (Day 5)Total protein: End of IV therapyTotal protein: Test of CureTotal protein: Early Follow-upTotal protein: Late Follow-up
GSK2251052 1500 mg-3.8-2.11.73.53.5-5.0-3.32.15.35.3
Imipenem-Cilastatin-0.30.82.63.43.21.03.06.46.44.8

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Change From Baseline in Clinical Laboratory Parameters- Albumin and Total Protein

Clinical laboratory parameters included albumin and total protein. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in albumin and total protein are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionGram per Liter (Mean)
Albumin: On IV therapy (Day 5)Albumin: On IV therapy (Day 11)Albumin: End of IV therapyAlbumin: Test of CureAlbumin: Early Follow-upAlbumin: Late Follow-upTotal protein: On IV therapy (Day 5)Total protein: On IV therapy (Day 11)Total protein: End of IV therapyTotal protein: Test of CureTotal protein: Early Follow-upTotal protein: Late Follow-up
GSK2251052 750 mg-0.52.01.05.78.27.30.0-5.0-0.45.89.48.2

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Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)

Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,
InterventionMillimole per Liter (Mean)
Calcium: On IV therapy (Day 5)Calcium: End of IV therapyCalcium: Test of CureCalcium: Early Follow-upCalcium: Late Follow-upC02 content/Bicarbonate: On IV therapy (Day 5)C02 content/Bicarbonate: End of IV therapyC02 content/Bicarbonate: Test of CureC02 content/Bicarbonate: Early Follow-upC02 content/Bicarbonate: Late Follow-upChloride: On IV therapy (Day 5)Chloride: End of IV therapyChloride: Test of CureChloride: Early Follow-upChloride: Late Follow-upGlucose: On IV therapy (Day 5)Glucose: End of IV therapyGlucose: Test of CureGlucose: Early Follow-upGlucose: Late Follow-upPotassium: On IV therapy (Day 5)Potassium: End of IV therapyPotassium: Test of CurePotassium: Early Follow-upPotassium: Late Follow-upSodium: On IV therapy (Day 5)Sodium: End of IV therapySodium: Test of CureSodium: Early Follow-upSodium: Late Follow-upUrea/BUN: On IV therapy (Day 5)Urea/BUN: End of IV therapyUrea/BUN: Test of CureUrea/BUN: Early Follow-upUrea/BUN: Late Follow-up
GSK2251052 1500 mg-0.1120.0710.0960.1200.1150.00.62.70.31.81.83.01.00.5-0.52.251.09-0.110.070.58-0.050.240.400.500.530.31.71.3-0.5-1.2-0.45-1.13-0.730.20-0.33
Imipenem-Cilastatin0.0600.0780.1280.1420.110-2.0-0.31.4-0.41.23.7-0.20.20.02.2-2.00-0.68-0.24-0.78-0.560.370.480.440.420.402.3-0.81.01.02.0-0.97-0.57-0.38-0.34-0.12

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Change From Baseline in Clinical Laboratory Parameters- Calcium, Carbon-dioxide (C02) Content/Bicarbonate, Chloride, Glucose, Potassium, Sodium and Urea/Blood Urea Nitrogen (BUN)

Clinical laboratory parameters included C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in C02 content/bicarbonate, chloride, glucose, potassium, sodium and urea/BUN are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMillimole per Liter (Mean)
Calcium: On IV therapy (Day 5)Calcium: On IV therapy (Day 11)Calcium: End of IV therapyCalcium: Test of CureCalcium: Early Follow-upCalcium: Late Follow-upC02 content/Bicarbonate: On IV therapy (Day 5)C02 content/Bicarbonate: On IV therapy (Day 11)C02 content/Bicarbonate: End of IV therapyC02 content/Bicarbonate: Test of CureC02 content/Bicarbonate: Early Follow-upC02 content/Bicarbonate: Late Follow-upChloride: On IV therapy (Day 5)Chloride: On IV therapy (Day 11)Chloride: End of IV therapyChloride: Test of CureChloride: Early Follow-upChloride: Late Follow-upGlucose: On IV therapy (Day 5)Glucose: On IV therapy (Day 11)Glucose: End of IV therapyGlucose: Test of CureGlucose: Early Follow-upGlucose: Late Follow-upPotassium: On IV therapy (Day 5)Potassium: On IV therapy (Day 11)Potassium: End of IV therapyPotassium: Test of CurePotassium: Early Follow-upPotassium: Late Follow-upSodium: On IV therapy (Day 5)Sodium: On IV therapy (Day 11)Sodium: End of IV therapySodium: Test of CureSodium: Early Follow-upSodium: Late Follow-upUrea/BUN: On IV therapy (Day 5)Urea/BUN: On IV therapy (Day 11)Urea/BUN: End of IV therapyUrea/BUN: Test of CureUrea/BUN: Early Follow-upUrea/BUN: Late Follow-up
GSK2251052 750 mg0.0820.030-0.0200.2350.2760.243-1.7-3.0-2.4-0.80.00.71.24.01.00.50.60.30.421.50-1.06-0.35-0.80-0.450.520.000.460.780.400.281.24.00.41.81.81.2-0.98-2.50-0.30-0.38-0.64-0.30

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Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)

Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMilliliter per minute (Mean)
CCE: Test of CureCCE: Early Follow-up
Imipenem-Cilastatin56.060.0

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Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)

Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMilliliter per minute (Mean)
CCE: Test of CureCCE: Early Follow-upCCE: Late Follow-up
GSK2251052 750 mg2.01.025.0

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Change From Baseline in Clinical Laboratory Parameters- Creatinine Clearance, Estimated (CCE)

Clinical laboratory parameters included CCE. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in CCE are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMilliliter per minute (Mean)
CCE: On IV therapy (Day 5)CCE: Test of CureCCE: Early Follow-upCCE: Late Follow-up
GSK2251052 1500 mg18.013.021.021.0

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Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin

Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,
InterventionMicromole per liter (Mean)
Creatinine: On IV therapy (Day 5)Creatinine: End of IV therapyCreatinine: Test of CureCreatinine: Early Follow-upCreatinine: Late Follow-upTotal bilirubin: On IV therapy (Day 3)Total bilirubin: On IV therapy (Day 5)Total bilirubin: On IV therapy (Day 8)Total bilirubin: End of IV therapyTotal bilirubin: Test of CureTotal bilirubin: Early Follow-upTotal bilirubin: Late Follow-up
GSK2251052 1500 mg-5.78-11.26-9.662.88-5.22-4.9-3.5-4.5-5.6-4.7-4.5-4.8
Imipenem-Cilastatin-11.97-8.70-8.54-4.56-5.22-7.2-7.3-1.0-5.5-6.4-6.0-5.0

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Change From Baseline in Clinical Laboratory Parameters- Creatinine, Direct Bilirubin and Total Bilirubin

Clinical laboratory parameters included creatinine, direct bilirubin and total bilirubin. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in creatinine, direct bilirubin and total bilirubin are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMicromole per liter (Mean)
Creatinine: On IV therapy (Day 5)Creatinine: On IV therapy (Day 11)Creatinine: End of IV therapyCreatinine: Test of CureCreatinine: Early Follow-upCreatinine: Late Follow-upTotal bilirubin: On IV therapy (Day 3)Total bilirubin: On IV therapy (Day 5)Total bilirubin: On IV therapy (Day 8)Total bilirubin: On IV therapy (Day 11)Total bilirubin: End of IV therapyTotal bilirubin: Test of CureTotal bilirubin: Early Follow-upTotal bilirubin: Late Follow-up
GSK2251052 750 mg-4.20-1.50-0.24-2.17-3.904.43-7.5-7.0-5.0-1.0-8.2-7.7-6.2-5.2

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Change From Baseline in Hematology Parameters- Basophils, Eosinophils, Lymphocytes, Monocytes, Platelet Count, Total Neutrophils and White Blood Cell Count (WBC)

Hematology parameters included basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in basophils, eosinophils, lymphocytes, monocytes, platelet count, total neutrophils and WBC are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,,
InterventionGigacells per Liter (Mean)
Basophils: End of IV therapyBasophils: Late Follow-upEosinophils: End of IV therapyEosinophils: Late Follow-upLymphocytes: End of IV therapyLymphocytes: Late Follow-upMonocytes: End of IV therapyMonocytes: Late Follow-upPlatelet count: End of IV therapyPlatelet count: Late Follow-upTotal neutrophils: End of IV therapyTotal neutrophils: Late Follow-upWBC count: End of IV therapyWBC count: Late Follow-up
GSK2251052 1500 mg0.0180.0200.0960.0670.5140.774-0.256-0.23083.245.4-6.695-7.737-6.30-7.11
GSK2251052 750 mg0.0280.0220.2740.0930.5800.687-0.188-0.380141.048.8-8.178-6.765-7.48-6.33
Imipenem-Cilastatin0.0140.0160.0900.0860.5960.436-0.442-0.186105.439.8-4.656-7.902-4.36-7.54

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Change From Baseline in Hematology Parameters- Hematocrit

Hematology parameters included hematocrit. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hematocrit are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,,
InterventionFraction (Mean)
End of IV therapyLate Follow-up
GSK2251052 1500 mg-0.0155-0.0007
GSK2251052 750 mg-0.01400.0373
Imipenem-Cilastatin-0.0120-0.0038

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Change From Baseline in Hematology Parameters- Hemoglobin and Mean Corpuscle Hemoglobin Concentration (MCHC)

Hematology parameters included hemoglobin and MCHC. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in hemoglobin and MCHC are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,,
InterventionGram per Liter (Mean)
Hemoglobin: End of IV therapyHemoglobin: Late Follow-upMCHC: End of IV therapyMCHC: Late Follow-up
GSK2251052 1500 mg-5.5-2.1-1.8-5.0
GSK2251052 750 mg-3.011.04.0-3.0
Imipenem-Cilastatin-2.5-0.64.21.8

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Change From Baseline in Hematology Parameters- Mean Corpuscle Hemoglobin (MCH)

Hematology parameters included MCH. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCH are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,,
InterventionPicograms (Mean)
End of IV therapyLate Follow-up
GSK2251052 1500 mg-0.60-0.89
GSK2251052 750 mg-0.60-0.85
Imipenem-Cilastatin-0.07-0.14

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Change From Baseline in Hematology Parameters- Mean Corpuscle Volume (MCV)

Hematology parameters included MCV. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in MCV are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,,
InterventionFemtoliters (Mean)
End of IV therapyLate Follow-up
GSK2251052 1500 mg-1.3-1.3
GSK2251052 750 mg-3.0-2.2
Imipenem-Cilastatin-1.0-0.8

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Change From Baseline in Hematology Parameters- Red Blood Cell (RBC) Count and Reticulocytes

Hematology parameters included RBC count and reticulocytes. Baseline was Day 1. Change from Baseline was calculated by subtracting Baseline values from individual post-Baseline values. Mean change from Baseline up to Late follow-up visit in RBC count and reticulocytes are presented. (NCT01381549)
Timeframe: Baseline (Day 1) to Late Follow up Visit (21 to 28 days post-IV therapy)

,,
InterventionTrillion cells per liter (Mean)
RBC: End of IV therapyRBC: Late Follow-upReticulocytes: End of IV therapyReticulocytes: Late Follow-up
GSK2251052 1500 mg-0.100.07-0.0312-0.0092
GSK2251052 750 mg-0.100.52-0.0331-0.0466
Imipenem-Cilastatin-0.080.02-0.00720.0080

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Number of Participants With Abnormal Electrocardiogram (ECG) Findings

Twelve lead ECGs were obtained during the study using an ECG machine that automatically measured PR, QRS, QT, and QT corrected by Bazett's formula (QTcB), QT corrected by Fridericia's formula (QTcF) intervals. Twelve lead ECGs were performed with the participant in a semi-supine position having rested in this position for at least 10 minutes beforehand. Measurements that deviated substantially from previous readings were repeated immediately. Three measurements were taken at pre-dose on Day 1 at least 5 min apart. One additional ECG measurement was taken after completion of the first infusion of study medication. Two ECG measurements (pre and post-1st infusion of the day) were taken on Day 4 while the participant was on IV therapy. When there was an abnormal finding, two more were taken and the mean PR interval, QRS duration, QT interval and QTcB were calculated from automated ECG readings. One ECG measurement was taken at the early safety follow-up visit. (NCT01381549)
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)

,,
InterventionParticipants (Count of Participants)
Day 1: Pre-dose 1Day 1: Pre-dose 2Day 1: Pre-dose 3Day 1: Post-doseDay 4 (on IV treatment): Pre-doseDay 4 (on IV treatment): Post-doseEarly Follow-upWithdrawal
GSK2251052 1500 mg44254330
GSK2251052 750 mg02112300
Imipenem-Cilastatin22332220

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Number of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)

AE is any untoward medical occurrence in a participant or clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. For marketed medicinal products, this also includes failure to produce expected benefits (i.e., lack of efficacy), abuse or misuse. SAE is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, or is a congenital anomaly/birth defect or is medically significant. (NCT01381549)
Timeframe: Up to 28 days post-therapy

,,
InterventionParticipants (Count of Participants)
AESAE
GSK2251052 1500 mg62
GSK2251052 750 mg51
Imipenem-Cilastatin50

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Summary of Vital Signs- Mean Heart Rate

Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented. (NCT01381549)
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)

InterventionBeats per minute (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)End of IV therapyTest of CureEarly Follow-upLate Follow-up
GSK2251052 1500 mg99.383.080.681.080.392.088.587.580.082.873.674.071.8

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Summary of Vital Signs- Mean Heart Rate

Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented. (NCT01381549)
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)

InterventionBeats per minute (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)On IV therapy (Day 10)End of IV therapyTest of CureEarly Follow-upLate Follow-up
Imipenem-Cilastatin87.781.581.473.668.274.878.382.085.086.071.074.665.878.2

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Summary of Vital Signs- Mean Heart Rate

Vital sign measurements included heart rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean heart rate is presented. (NCT01381549)
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)

InterventionBeats per minute (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)On IV therapy (Day 10)On IV therapy (Day 11)On IV therapy (Day 12)On IV therapy (Day 13)On IV therapy (Day 14)End of IV therapyTest of CureEarly Follow-upLate Follow-up
GSK2251052 750 mg85.878.277.878.572.389.081.088.084.091.0100.084.090.092.072.874.572.576.8

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Summary of Vital Signs- Mean Respiration Rate

Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented. (NCT01381549)
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)

InterventionBreaths/minute (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)End of IV therapyTest of CureEarly Follow-upLate Follow-up
GSK2251052 1500 mg19.618.116.617.316.617.016.515.016.015.815.515.916.0

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Summary of Vital Signs- Mean Respiration Rate

Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented. (NCT01381549)
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)

InterventionBreaths/minute (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)On IV therapy (Day 10)End of IV therapyTest of CureEarly Follow-upLate Follow-up
Imipenem-Cilastatin17.316.816.817.818.816.017.320.022.020.016.418.216.416.6

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Summary of Vital Signs- Mean Respiration Rate

Vital sign measurements included respiratory rate. Measurements that deviated substantially from previous readings were repeated immediately. Mean respiration rate are presented. (NCT01381549)
Timeframe: Up to Late Follow-up Visit (21 to 28 days post-IV therapy)

InterventionBreaths/minute (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)On IV therapy (Day 10)On IV therapy (Day 11)On IV therapy (Day 12)On IV therapy (Day 13)On IV therapy (Day 14)End of IV therapyTest of CureEarly Follow-upLate Follow-up
GSK2251052 750 mg17.315.014.215.514.516.016.016.014.017.015.016.014.014.016.014.015.313.4

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Summary of Vital Signs- Mean Temperature

Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF). (NCT01381549)
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionCelsius (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)End of IV therapyTest of CureEarly Follow-upLate Follow-up
GSK2251052 1500 mg38.4137.3036.7936.7136.5936.9036.9536.8036.8036.7535.9835.9936.08

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Summary of Vital Signs- Mean Temperature

Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF). (NCT01381549)
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionCelsius (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)On IV therapy (Day 10)End of IV therapyTest of CureEarly Follow-upLate Follow-up
Imipenem-Cilastatin38.3037.3037.7437.3836.9636.4036.9336.5036.5036.5036.3836.1436.2836.00

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Summary of Vital Signs- Mean Temperature

Vital sign measurements included temperature (oral, tympanic or rectal). Measurements that deviated substantially from previous readings were repeated immediately. Temperature was assessed as normal hospital practice dictated and the maximum daily temperature was recorded in the electronic case report form (eCRF). (NCT01381549)
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionCelsius (Mean)
Baseline (Day 1)On IV therapy (Day 2)On IV therapy (Day 3)On IV therapy (Day 4)On IV therapy (Day 5)On IV therapy (Day 6)On IV therapy (Day 7)On IV therapy (Day 8)On IV therapy (Day 9)On IV therapy (Day 10)On IV therapy (Day 11)On IV therapy (Day 12)On IV therapy (Day 13)On IV therapy (Day 14)End of IV therapyTest of CureEarly Follow-upLate Follow-up
GSK2251052 750 mg38.0836.9736.7536.6036.2737.0036.2036.8036.5037.0037.0036.8036.2036.8036.1836.2536.2336.40

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Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented. (NCT01381549)
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMillimeters of mercury (mmHg) (Mean)
SBP: Baseline (Day 1)SBP: On IV therapy (Day 2)SBP: On IV therapy (Day 3)SBP: On IV therapy (Day 4)SBP: On IV therapy (Day 5)SBP: On IV therapy (Day 6)SBP: On IV therapy (Day 7)SBP: On IV therapy (Day 8)SBP: On IV therapy (Day 9)SBP: End of IV therapySBP: Test of CureSBP: Early Follow-upSBP: Late Follow-upDBP: Baseline (Day 1)DBP: On IV therapy (Day 2)DBP: On IV therapy (Day 3)DBP: On IV therapy (Day 4)DBP: On IV therapy (Day 5)DBP: On IV therapy (Day 6)DBP: On IV therapy (Day 7)DBP: On IV therapy (Day 8)DBP: On IV therapy (Day 9)DBP: End of IV therapyDBP: Test of CureDBP: Early Follow-upDBP: Late Follow-up
GSK2251052 1500 mg131.9125.4126.6127.0126.6125.5125.0125.0130.0116.1126.9120.1117.677.369.072.179.579.781.070.069.080.069.470.672.067.5

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Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented. (NCT01381549)
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMillimeters of mercury (mmHg) (Mean)
SBP: Baseline (Day 1)SBP: On IV therapy (Day 2)SBP: On IV therapy (Day 3)SBP: On IV therapy (Day 4)SBP: On IV therapy (Day 5)SBP: On IV therapy (Day 6)SBP: On IV therapy (Day 7)SBP: On IV therapy (Day 8)SBP: On IV therapy (Day 9)SBP: On IV therapy (Day 10)SBP: End of IV therapySBP: Test of CureSBP: Early Follow-upSBP: Late Follow-upDBP: Baseline (Day 1)DBP: On IV therapy (Day 2)DBP: On IV therapy (Day 3)DBP: On IV therapy (Day 4)DBP: On IV therapy (Day 5)DBP: On IV therapy (Day 6)DBP: On IV therapy (Day 7)DBP: On IV therapy (Day 8)DBP: On IV therapy (Day 9)DBP: On IV therapy (Day 10)DBP: End of IV therapyDBP: Test of CureDBP: Early Follow-upDBP: Late Follow-up
Imipenem-Cilastatin120.0120.0123.8124.2116.8115.0116.7110.0105.0110.0117.5126.4123.8116.666.570.371.269.667.072.567.770.065.070.071.571.868.865.0

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Summary of Vital Signs: Mean Systolic Blood Pressure (SBP) and Diastolic Blood Pressure (DBP)

Vital sign measurements included SBP and DBP (supine or semi-supine). Measurements that deviated substantially from previous readings were repeated immediately. Mean SBP and DBP are presented. (NCT01381549)
Timeframe: Up to Late Follow up Visit (21 to 28 days post-IV therapy)

InterventionMillimeters of mercury (mmHg) (Mean)
SBP: Baseline (Day 1)SBP: On IV therapy (Day 2)SBP: On IV therapy (Day 3)SBP: On IV therapy (Day 4)SBP: On IV therapy (Day 5)SBP: On IV therapy (Day 6)SBP: On IV therapy (Day 7)SBP: On IV therapy (Day 8)SBP: On IV therapy (Day 9)SBP: On IV therapy (Day 10)SBP: On IV therapy (Day 11)SBP: On IV therapy (Day 12)SBP: On IV therapy (Day 13)SBP: On IV therapy (Day 14)SBP: End of IV therapySBP: Test of CureSBP: Early Follow-upSBP: Late Follow-upDBP: Baseline (Day 1)DBP: On IV therapy (Day 2)DBP: On IV therapy (Day 3)DBP: On IV therapy (Day 4)DBP: On IV therapy (Day 5)DBP: On IV therapy (Day 6)DBP: On IV therapy (Day 7)DBP: On IV therapy (Day 8)DBP: On IV therapy (Day 9)DBP: On IV therapy (Day 10)DBP: On IV therapy (Day 11)DBP: On IV therapy (Day 12)DBP: On IV therapy (Day 13)DBP: On IV therapy (Day 14)DBP: End of IV therapyDBP: Test of CureDBP: Early Follow-upDBP: Late Follow-up
GSK2251052 750 mg129.7131.2123.8137.8135.2150.0165.0170.0161.0140.0155.0140.0130.0152.0130.0131.3128.0148.068.078.377.285.583.890.085.090.095.069.069.075.080.069.074.082.273.887.7

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Clinical Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit

Clinical response was a combination of clinical success and clinical failure. In clinical success, participants showed no signs and symptoms of pyelonephritis and lower complicated urinary tract infection and antibiotics are not used for the same. In clinical failure, there is reappearance of signs and symptoms of and lower complicated urinary tract infection and participant required antibiotics for the same. (NCT01381549)
Timeframe: End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)

InterventionParticipants (Count of Participants)
End of IV therapy72057612End of IV therapy72057610End of IV therapy72057611Test of Cure72057612Test of Cure72057611Test of Cure72057610Late Follow-up72057612Late Follow-up72057610Late Follow-up72057611
Clinical SuccessClinical Failure
GSK2251052 750 mg4
Imipenem-Cilastatin5
GSK2251052 750 mg2
Imipenem-Cilastatin0
GSK2251052 1500 mg6
Imipenem-Cilastatin4
GSK2251052 1500 mg2
Imipenem-Cilastatin1
GSK2251052 750 mg3
Imipenem-Cilastatin2
Imipenem-Cilastatin3

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Microbiological Response at the End of IV Therapy Visit, Test of Cure Visit and Late Follow-Up Visit

Microbiological response involved both microbiological success and microbiological failure. A reduction in the uropathogens in the urine culture and no growth on blood culture was termed as microbiological success. Increase in the uropathogens in the urine culture and pathogens identified in the blood culture or use of antibacterials other than study treatments were classified as microbiological failures. (NCT01381549)
Timeframe: End of IV therapy (0-24 hours post-therapy), Test of Cure Visit (5 to 9 days post-IV therapy) and Late Follow-up (21-28 days post-therapy)

InterventionParticipants (Count of Participants)
End of IV therapy72057612End of IV therapy72057610End of IV therapy72057611Test of Cure72057612Test of Cure72057610Test of Cure72057611Late Folllow-up72057612Late Folllow-up72057610Late Folllow-up72057611
Microbiological SuccessMicrobiological Failure
Imipenem-Cilastatin5
GSK2251052 750 mg3
Imipenem-Cilastatin0
GSK2251052 750 mg1
GSK2251052 1500 mg5
Imipenem-Cilastatin1
GSK2251052 750 mg5
GSK2251052 1500 mg3
Imipenem-Cilastatin4
GSK2251052 750 mg2
GSK2251052 1500 mg6
GSK2251052 750 mg4
GSK2251052 1500 mg2

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Therapeutic Response (Combined Clinical and Microbiological Response) at the End of IV Visit and Late Follow-Up Visit

The therapeutic response was the combination of a participant's clinical and microbiological response. It was assessed at the Test of Cure visit in participants who have a qualifying Gram-negative uropathogen at Baseline and have had a minimum of 5 days of IV therapy. Therapeutic response was a measure of the overall efficacy response, and a therapeutic success referred to participants who have been deemed both a 'clinical success' and a 'microbiological success'. All other combinations (other than 'clinical success' + 'microbiological success') were deemed failures for therapeutic response. (NCT01381549)
Timeframe: End of IV therapy (0-24 hours post-therapy) and Late Follow-up (21-28 days post-therapy)

InterventionParticipants (Count of Participants)
End of IV therapy72057612End of IV therapy72057611End of IV therapy72057610Late Follow-up72057612Late Follow-up72057610Late Follow-up72057611
Therapeutic FailureTherapeutic Success
GSK2251052 750 mg3
GSK2251052 1500 mg5
Imipenem-Cilastatin5
GSK2251052 1500 mg3
Imipenem-Cilastatin0
GSK2251052 750 mg2
GSK2251052 1500 mg6
Imipenem-Cilastatin1
GSK2251052 750 mg4
GSK2251052 1500 mg2
Imipenem-Cilastatin4

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Percentage of Participants With ≥1 Events of Clinical Interest (ECI)

The percentage of participants in Groups 1, 2, and 3 having ECIs within 2 categories was determined. Category 1 ECIs included post-baseline laboratory values of an elevated aspartate aminotransferase (AST) or alanine aminotransferase (ALT) value that is ≥3x upper limit of normal (ULN) and an elevated total bilirubin value that is ≥2x ULN and (at the same time) an alkaline phosphatase value that is ≤2x ULN. Category 2 ECIs included a confirmed elevated AST or ALT value that is ≥5x ULN. Statistical analysis included only Groups 1 and 2 as indicated by the protocol. (NCT02452047)
Timeframe: Up to Day 35 (up to 14 days after completing study treatment)

,
InterventionPercentage of Participants (Number)
Category 1 ECICategory 2 ECI
Group 1: Imipenem+Cilastatin/Relebactam0.00.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin12.512.5

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Analysis of Specific AEs With an Incidence of ≥4 Participants in a Treatment Group

The percentage of participants experiencing AEs that occurred in ≥4 participants within either Group 1 or Group 2 was assessed. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol; Group 3 had <4 participants and therefore no data are presented. (NCT02452047)
Timeframe: Up to Day 35 (up to 14 days after completing study treatment)

,
InterventionPercentage of Participants (Number)
PyrexiaBlood creatinine increased
Group 1: Imipenem+Cilastatin/Relebactam12.90.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin12.525.0

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Percentage of Participants With FCR on Therapy (OTX)

"The percentage of participants with a FCR at OTX was determined for Groups 1 and 2. FCR at OTX was defined as improved. Improved was defined as all or most pretherapy signs and symptoms of index infection have improved or resolved, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed." (NCT02452047)
Timeframe: OTX (Day 3)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam81.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin40.0

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Percentage of Participants With FCR at End of Therapy (EOT)

"The percentage of participants with FCR at EOT was determined for Groups 1 and 2. FCR at EOT was defined as cure or improved. Cure was defined as all pretherapy signs and symptoms of index infection resolved or returned to preinfection status, and no additional IV antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures performed. Improved was defined as all or most pretherapy signs and symptoms of index infection have improved or resolved, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed." (NCT02452047)
Timeframe: At EOT (up to Day 21)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam90.5
Group 2: Colistimethate Sodium + Imipenem+Cilastatin60.0

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Percentage of Participants With FCR at EFU

"The percentage of participants with FCR at EFU was determined for Groups 1 and 2. FCR at EFU was defined as sustained cure or cure. Sustained cure (for participants with cure response at the prior visit) was defined as all pretherapy signs and symptoms of index infection resolved with no evidence of resurgence and no additional antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed. Cure (for participants with improved response at EOT visit) was defined as all pretherapy signs and symptoms of index infection resolved or returned to preinfection status, and no additional IV antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures performed." (NCT02452047)
Timeframe: EFU (Between Day 10 and Day 30 [5 to 9 Days after EOT])

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam81.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin50.0

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Percentage of Participants With Favorable Overall Response (FOR)

The percentage of participants with FOR was determined for Groups 1 and 2. FOR was determined based on clinically relevant outcomes for the primary site of infection as follows: HABP/VABP: survival through Day 28; cIAI: favorable clinical response (all pretherapy symptoms of index infection resolved with no evidence of resurgence, no additional antibiotic therapy required, and no unplanned surgical or percutaneous drainage procedures) at Day 28; cUTI: favorable composite clinical response (all pretherapy symptoms of index infection resolved with no evidence of resurgence, no additional antibiotic therapy required) and microbiological response (urine culture shows sustained eradication of the baseline uropathogen [e.g., ≥10^5 CFU/mL at study entry is reduced to <10^4 CFU/mL]) at Early Follow-up (EFU). (NCT02452047)
Timeframe: Up to Day 30 (up to 9 days after completing study treatment)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam71.4
Group 2: Colistimethate Sodium + Imipenem+Cilastatin70.0

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Percentage of Participants With All-cause Mortality Up to Day 28

The percentage of participants with all-cause mortality up to Day 28 was determined for Groups 1 and 2. (NCT02452047)
Timeframe: Up to Day 28

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam9.5
Group 2: Colistimethate Sodium + Imipenem+Cilastatin30.0

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Percentage of Participants With ≥1 Serious Adverse Events (SAEs)

The percentage of participants in Groups 1, 2, and 3 experiencing ≥1 SAEs during treatment and 14-day follow-up was determined. An SAE is any untoward medical occurrence that, at any dose, results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent or significant injury/incapacity; is a congenital anomaly/birth defect; or is an other important medical event. Statistical analysis included only Groups 1 and 2 as indicated by the protocol. (NCT02452047)
Timeframe: Up to Day 35 (up to 14 days after completing study treatment)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam9.7
Group 2: Colistimethate Sodium + Imipenem+Cilastatin31.3
Group 3: Open-Label Imipenem+Cilastatin/Relebactam100.0

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Percentage of Participants With ≥1 Events of Treatment-Emergent Nephrotoxicity

"Treatment-emergent nephrotoxity was assessed in Groups 1 and 2 as indicated by the protocol (Group 3 was not included). Nephrotoxicity for participants with normal baseline serum creatinine levels (<1.2 mg/dL) was defined as doubling of serum creatinine to >1.2 mg/dL or reduction in creatinine clearance (ClCR) of ≥50%. Nephrotoxicity for participants with pre-existing renal dysfunction (baseline serum creatinine level ≥1.2 mg/dL) was defined as increase in serum creatinine by ≥1 mg/dL or reduction from baseline ClCR of ≥20% or need for renal replacement therapy (RRT)." (NCT02452047)
Timeframe: Up to Day 35 (up to 14 days after completing study treatment)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam10.3
Group 2: Colistimethate Sodium + Imipenem+Cilastatin56.3

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Percentage of Participants With Favorable Clinical Response (FCR) at Day 28

"The percentage of participants with FCR at Day 28 was determined for Groups 1 and 2. FCR at Day 28 was defined as sustained cure or cure. Sustained cure (for participants with cure response at the prior visit) was defined as all pretherapy signs and symptoms of index infection resolved with no evidence of resurgence and no additional antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures have been performed. Cure (for participants with improved response at EOT visit) was defined as all pretherapy signs and symptoms of index infection resolved or returned to preinfection status, and no additional IV antibiotic therapy required, and (for cIAI participants) no unplanned surgical procedures or percutaneous drainage procedures performed." (NCT02452047)
Timeframe: Day 28

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam71.4
Group 2: Colistimethate Sodium + Imipenem+Cilastatin40.0

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Percentage of Participants With ≥1 Adverse Events (AEs)

The percentage of participants in Groups 1, 2, and 3 experiencing ≥1 AEs during treatment and 14-day follow-up was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol. (NCT02452047)
Timeframe: Up to Day 35 (up to 14 days after completing study treatment)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam71.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin81.3
Group 3: Open-Label Imipenem+Cilastatin/Relebactam100.0

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Percentage of Participants Discontinuing From Study Therapy Due to ≥1 AEs

The percentage of participants in Group 1, 2, and 3 discontinuing from study drug due to ≥1 AEs during the treatment period was determined. An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of study intervention, whether or not considered related to the study intervention. Statistical analysis included only Groups 1 and 2 as indicated by the protocol. (NCT02452047)
Timeframe: Up to Day 21

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam0.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin18.8
Group 3: Open-Label Imipenem+Cilastatin/Relebactam33.3

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Percentage of cUTI Participants With FMR at EOT

"The percentage of participants with FMR at EOT was determined for participants with cUTI in Groups 1 and 2. FMR was defined as urine culture results at EOT showing eradication (i.e., ≥10^5 CFU/mL at baseline was reduced to <10^4 CFU/mL at EOT) or sustained eradication (i.e., ≥10^5 CFU/mL at baseline that was reduced to <10^4 CFU/mL previously remained <10^4 CFU/mL at EOT) of the uropathogen." (NCT02452047)
Timeframe: At EOT (up to Day 21)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam100.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin100.0

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Percentage of cUTI Participants With FMR at EFU

"The percentage of participants with FMR at EFU was determined for participants with cUTI in Groups 1 and 2. FMR was defined as urine culture results at EFU showing sustained eradication (i.e., ≥10^5 CFU/mL at baseline that was reduced to <10^4 CFU/mL previously remained <10^4 CFU/mL at EFU) of the uropathogen." (NCT02452047)
Timeframe: EFU (Between Day 10 and Day 30 [5 to 9 Days after EOT])

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam72.7
Group 2: Colistimethate Sodium + Imipenem+Cilastatin100.0

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Percentage of cUTI Participants With Favorable Microbiological Response (FMR) at OTX

"The percentage of participants with FMR at OTX was determined for participants with cUTI in Groups 1 and 2. FMR was defined as urine culture results at OTX showing eradication (i.e., ≥10^5 colony forming units [CFU]/mL at baseline was reduced to <10^4 CFU/mL at OTX) of the uropathogen." (NCT02452047)
Timeframe: OTX (Day 3)

InterventionPercentage of Participants (Number)
Group 1: Imipenem+Cilastatin/Relebactam100.0
Group 2: Colistimethate Sodium + Imipenem+Cilastatin100.0

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Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at End of Therapy Visit

"The percentage of participants with cIAI who display a favorable clinical response at End of Therapy visit was presented. Per protocol, a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because clinical response is primarily relevant to cIAI. Favorable clinical response is a rating of cure or improved as determined by the investigator at the End of Therapy Visit. Cure is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed. Improved is defined as: All or most pretherapy signs and symptoms of the index infection(s) have improved or resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed." (NCT03293485)
Timeframe: Between Day 5 and Day 14 (End of Therapy Visit)

InterventionPercentage of Participants (Number)
cIAI85.7

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Percentage of Participants Who Discontinued Study Drug Due to an Adverse Event (AE)

The percentage of participants who discontinued from study medication due to an adverse event was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT03293485)
Timeframe: Up to 14 days (End of Therapy Visit)

InterventionPercentage of Participants (Number)
cIAI/cUTI4.9

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Percentage of Participants Experiencing ≥1 Adverse Events (AE)

The percentage of participants experiencing ≥1 AE was calculated. An AE was defined as any unfavorable and unintended sign, symptom, or disease (new or worsening) temporally associated with the use of study therapy, regardless of whether or not a causal relationship with the study therapy could be determined. (NCT03293485)
Timeframe: Up to 28 days

InterventionPercentage of Participants (Number)
cIAI/cUTI74.1

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Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at Test of Cure Visit

The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the Test of Cure visit still showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry. (NCT03293485)
Timeframe: Between Day 10 and Day 23 (Test of Cure Visit)

InterventionPercentage of Participants (Number)
cUTI59.0

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Percentage of Complicated Urinary Tract Infection (cUTI) Participants With Favorable Overall Microbiological Response at End of Therapy Visit

The percentage of participants with cUTI who display a favorable Overall Microbiological Response at the End of Therapy visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cUTI were evaluated because the microbiological response evaluation is primarily relevant to cUTI. A favorable Overall Microbiological Response is defined as a urine culture taken at the End of Therapy Visit showing eradication (e.g., ≥10^5 CFU/mL is reduced to <10^4 CFU/mL) of all uropathogens found at study entry. (NCT03293485)
Timeframe: Between Day 5 and Day 14 (End of Therapy Visit)

InterventionPercentage of Participants (Number)
cUTI100

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Percentage of Complicated Intra-Abdominal Infection (cIAI) Participants With Favorable Clinical Response at Test of Cure Visit

"The percentage of participants with cIAI who display a favorable Clinical Response at the Test of Cure visit was calculated. Per protocol, only a subset of the cIAI/cUTI study arm was analyzed: only participants with cIAI were evaluated because the clinical response evaluation is primarily relevant to cIAI. A favorable clinical response is a rating of cure as determined by the investigator at the Test of Cure Visit. Cure is defined as: all pretherapy signs and symptoms of the index infection(s) have resolved (or returned to preinfection status) AND no additional intravenous antibiotic therapy is required AND no unplanned surgical or percutaneous drainage procedures have been performed." (NCT03293485)
Timeframe: Between Day 10 and Day 23 (Test of Cure Visit)

InterventionPercentage of Participants (Number)
cIAI82.1

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Microbiologic Eradication

Proportion of patients with a response of microbiologic eradication for the m-MITT(microbiologically modified intent to treat) and ME(microbiologically evaluable) populations at the TOC visit (NCT03445195)
Timeframe: Baseline to day 21

,
InterventionParticipants (Count of Participants)
m-MITT populationME population
Placebo + Imipenem/Cilastatin1717
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin3736

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Clinical Cure

Proportion of patients with a response of clinical cure for the MITT(modified intent to treat), m-MITT (microbiologically modified intent to treat), CE(clinically evaluable), and ME(microbiologically evaluable) populations at the TOC(test of cure) visit. (NCT03445195)
Timeframe: Baseline to day 21

,
InterventionParticipants (Count of Participants)
MITT populationm-MITT populationCE populationME population
Placebo + Imipenem/Cilastatin27212721
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin52465245

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Number of Participants With Overall Success

The primary efficacy endpoint for this study was the proportion of patients with an overall success (clinical cure and micro-biologic eradication) for the m-MITT (Micro-biologically Modified Intent-to-Treat) Population at the TOC Visit. (NCT03445195)
Timeframe: From baseline through day 21

InterventionParticipants (Count of Participants)
Sulbactam-ETX2514 (ETX2514SUL) + Imipenem/Cilastatin36
Placebo + Imipenem/Cilastatin17

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SubstanceRelationship StrengthStudiesTrialsClassesRoles
gamma-aminobutyric acid
gamma-Aminobutyric Acid: The most common inhibitory neurotransmitter in the central nervous system.. gamma-aminobutyric acid : A gamma-amino acid that is butanoic acid with the amino substituent located at C-4.		1.9710amino acid zwitterion;
gamma-amino acid;
monocarboxylic acid		human metabolite;
neurotransmitter;
Saccharomyces cerevisiae metabolite;
signalling molecule
beta-alanine
[no description available]		6.1191amino acid zwitterion;
beta-amino acid		agonist;
fundamental metabolite;
human metabolite;
inhibitor;
neurotransmitter
lactic acid
Lactic Acid: A normal intermediate in the fermentation (oxidation, metabolism) of sugar. The concentrated form is used internally to prevent gastrointestinal fermentation. (From Stedman, 26th ed). 2-hydroxypropanoic acid : A 2-hydroxy monocarboxylic acid that is propanoic acid in which one of the alpha-hydrogens is replaced by a hydroxy group.		2.15102-hydroxy monocarboxylic acidalgal metabolite;
Daphnia magna metabolite
2-amino-5-phosphonovalerate
2-Amino-5-phosphonovalerate: The D-enantiomer is a potent and specific antagonist of NMDA glutamate receptors (RECEPTORS, N-METHYL-D-ASPARTATE). The L form is inactive at NMDA receptors but may affect the AP4 (2-amino-4-phosphonobutyrate; APB) excitatory amino acid receptors.		2.0210non-proteinogenic alpha-amino acidNMDA receptor antagonist
1-hydroxy-3-amino-2-pyrrolidone
1-hydroxy-3-amino-2-pyrrolidone: a CNS depressant; structure in first source		2.0210
ambroxol
Ambroxol: A metabolite of BROMHEXINE that stimulates mucociliary action and clears the air passages in the respiratory tract. It is usually administered as the hydrochloride.		2.2510aromatic amine
amlodipine
Amlodipine: A long-acting dihydropyridine calcium channel blocker. It is effective in the treatment of ANGINA PECTORIS and HYPERTENSION.. amlodipine : A fully substituted dialkyl 1,4-dihydropyridine-3,5-dicarboxylate derivative, which is used for the treatment of hypertension, chronic stable angina and confirmed or suspected vasospastic angina.		2.2510dihydropyridine;
ethyl ester;
methyl ester;
monochlorobenzenes;
primary amino compound		antihypertensive agent;
calcium channel blocker;
vasodilator agent
aztreonam
Aztreonam: A monocyclic beta-lactam antibiotic originally isolated from Chromobacterium violaceum. It is resistant to beta-lactamases and is used in gram-negative infections, especially of the meninges, bladder, and kidneys. It may cause a superinfection with gram-positive organisms.. aztreonam : A synthetic monocyclic beta-lactam antibiotic (monobactam), used primarily to treat infections caused by Gram-negative bacteria. It inhibits mucopeptide synthesis in the bacterial cell wall, thereby blocking peptidoglycan crosslinking.		6.2561
ciprofloxacin
Ciprofloxacin: A broad-spectrum antimicrobial carboxyfluoroquinoline.. ciprofloxacin : A quinolone that is quinolin-4(1H)-one bearing cyclopropyl, carboxylic acid, fluoro and piperazin-1-yl substituents at positions 1, 3, 6 and 7, respectively.		8.67125aminoquinoline;
cyclopropanes;
fluoroquinolone antibiotic;
N-arylpiperazine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone;
zwitterion		antibacterial drug;
antiinfective agent;
antimicrobial agent;
DNA synthesis inhibitor;
EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor;
environmental contaminant;
topoisomerase IV inhibitor;
xenobiotic
valproic acid
Valproic Acid: A fatty acid with anticonvulsant and anti-manic properties that is used in the treatment of EPILEPSY and BIPOLAR DISORDER. The mechanisms of its therapeutic actions are not well understood. It may act by increasing GAMMA-AMINOBUTYRIC ACID levels in the brain or by altering the properties of VOLTAGE-GATED SODIUM CHANNELS.. valproic acid : A branched-chain saturated fatty acid that comprises of a propyl substituent on a pentanoic acid stem.		2.1310branched-chain fatty acid;
branched-chain saturated fatty acid		anticonvulsant;
antimanic drug;
EC 3.5.1.98 (histone deacetylase) inhibitor;
GABA agent;
neuroprotective agent;
psychotropic drug;
teratogenic agent
enoxacin
Enoxacin: A broad-spectrum 6-fluoronaphthyridinone antibacterial agent that is structurally related to NALIDIXIC ACID.. enoxacin : A 1,8-naphthyridine derivative that is 1,4-dihydro-1,8-naphthyridine with an ethyl group at the 1 position, a carboxy group at the 3-position, an oxo sustituent at the 4-position, a fluoro substituent at the 5-position and a piperazin-1-yl group at the 7 position. An antibacterial, it is used in the treatment of urinary-tract infections and gonorrhoea.		2.01101,8-naphthyridine derivative;
amino acid;
fluoroquinolone antibiotic;
monocarboxylic acid;
N-arylpiperazine;
quinolone antibiotic		antibacterial drug;
DNA synthesis inhibitor
fleroxacin
Fleroxacin: A broad-spectrum antimicrobial fluoroquinolone. The drug strongly inhibits the DNA-supercoiling activity of DNA GYRASE.. fleroxacin : A fluoroquinolone antibiotic that is 4-oxo-1,4-dihydroquinoline which is substituted at positions 1, 3, 6, 7 and 8 by 2-fluoroethyl, carboxy, fluoro, 4-methylpiperazin-1-yl and fluoro groups, respectively. It is active against many Gram-positive and Gram-negative bacteria.		2.0110difluorobenzene;
fluoroquinolone antibiotic;
monocarboxylic acid;
N-alkylpiperazine;
quinolines		antibacterial drug;
EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor;
topoisomerase IV inhibitor
fluconazole
Fluconazole: Triazole antifungal agent that is used to treat oropharyngeal CANDIDIASIS and cryptococcal MENINGITIS in AIDS.. fluconazole : A member of the class of triazoles that is propan-2-ol substituted at position 1 and 3 by 1H-1,2,4-triazol-1-yl groups and at position 2 by a 2,4-difluorophenyl group. It is an antifungal drug used for the treatment of mucosal candidiasis and for systemic infections including systemic candidiasis, coccidioidomycosis, and cryptococcosis.		2.0310conazole antifungal drug;
difluorobenzene;
tertiary alcohol;
triazole antifungal drug		environmental contaminant;
P450 inhibitor;
xenobiotic
gentamicin
Gentamicins: A complex of closely related aminoglycosides obtained from MICROMONOSPORA purpurea and related species. They are broad-spectrum antibiotics, but may cause ear and kidney damage. They act to inhibit PROTEIN BIOSYNTHESIS.		6.85155
lidocaine
Lidocaine: A local anesthetic and cardiac depressant used as an antiarrhythmia agent. Its actions are more intense and its effects more prolonged than those of PROCAINE but its duration of action is shorter than that of BUPIVACAINE or PRILOCAINE.. lidocaine : The monocarboxylic acid amide resulting from the formal condensation of N,N-diethylglycine with 2,6-dimethylaniline.		3.3611benzenes;
monocarboxylic acid amide;
tertiary amino compound		anti-arrhythmia drug;
drug allergen;
environmental contaminant;
local anaesthetic;
xenobiotic
lomefloxacin
lomefloxacin: structure given in first source. lomefloxacin : A fluoroquinolone antibiotic, used (generally as the hydrochloride salt) to treat bacterial infections including bronchitis and urinary tract infections. It is also used to prevent urinary tract infections prior to surgery.		2.0110fluoroquinolone antibiotic;
N-arylpiperazine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone		antimicrobial agent;
antitubercular agent;
photosensitizing agent
metronidazole
Metronidazole: A nitroimidazole used to treat AMEBIASIS; VAGINITIS; TRICHOMONAS INFECTIONS; GIARDIASIS; ANAEROBIC BACTERIA; and TREPONEMAL INFECTIONS.. metronidazole : A member of the class of imidazoles substituted at C-1, -2 and -5 with 2-hydroxyethyl, nitro and methyl groups respectively. It has activity against anaerobic bacteria and protozoa, and has a radiosensitising effect on hypoxic tumour cells. It may be given by mouth in tablets, or as the benzoate in an oral suspension. The hydrochloride salt can be used in intravenous infusions. Metronidazole is a prodrug and is selective for anaerobic bacteria due to their ability to intracellularly reduce the nitro group of metronidazole to give nitroso-containing intermediates. These can covalently bind to DNA, disrupting its helical structure, inducing DNA strand breaks and inhibiting bacterial nucleic acid synthesis, ultimately resulting in bacterial cell death.		6.5887C-nitro compound;
imidazoles;
primary alcohol		antiamoebic agent;
antibacterial drug;
antimicrobial agent;
antiparasitic agent;
antitrichomonal drug;
environmental contaminant;
prodrug;
radiosensitizing agent;
xenobiotic
nafamostat
nafamostat: inhibitor of trypsin, plasmin, pancreatic kallikrein, plasma kallikrein & thrombin; strongly inhibits esterolytic activities of C1r & C1 esterase complement-mediated hemolysis; antineoplastic		2.0110benzoic acids;
guanidines
norfloxacin
Norfloxacin: A synthetic fluoroquinolone (FLUOROQUINOLONES) with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin inhibits bacterial DNA GYRASE.. norfloxacin : A quinolinemonocarboxylic acid with broad-spectrum antibacterial activity against most gram-negative and gram-positive bacteria. Norfloxacin is bactericidal and its mode of action depends on blocking of bacterial DNA replication by binding itself to an enzyme called DNA gyrase.		2.0110fluoroquinolone antibiotic;
N-arylpiperazine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone		antibacterial drug;
DNA synthesis inhibitor;
environmental contaminant;
xenobiotic
ofloxacin
Ofloxacin: A synthetic fluoroquinolone antibacterial agent that inhibits the supercoiling activity of bacterial DNA GYRASE, halting DNA REPLICATION.. 9-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid : An oxazinoquinoline that is 2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinolin-7-one substituted by methyl, carboxy, fluoro, and 4-methylpiperazin-1-yl groups at positions 3, 6, 9, and 10, respectively.. ofloxacin : A racemate comprising equimolar amounts of levofloxacin and dextrofloxacin. It is a synthetic fluoroquinolone antibacterial agent which inhibits the supercoiling activity of bacterial DNA gyrase, halting DNA replication.		6.28853-oxo monocarboxylic acid;
N-arylpiperazine;
N-methylpiperazine;
organofluorine compound;
oxazinoquinoline
sulfamethoxazole
Sulfamethoxazole: A bacteriostatic antibacterial agent that interferes with folic acid synthesis in susceptible bacteria. Its broad spectrum of activity has been limited by the development of resistance. (From Martindale, The Extra Pharmacopoeia, 30th ed, p208). sulfamethoxazole : An isoxazole (1,2-oxazole) compound having a methyl substituent at the 5-position and a 4-aminobenzenesulfonamido group at the 3-position.		2.1110isoxazoles;
substituted aniline;
sulfonamide antibiotic;
sulfonamide		antibacterial agent;
antiinfective agent;
antimicrobial agent;
drug allergen;
EC 1.1.1.153 [sepiapterin reductase (L-erythro-7,8-dihydrobiopterin forming)] inhibitor;
EC 2.5.1.15 (dihydropteroate synthase) inhibitor;
environmental contaminant;
epitope;
P450 inhibitor;
xenobiotic
prednisolone
Prednisolone: A glucocorticoid with the general properties of the corticosteroids. It is the drug of choice for all conditions in which routine systemic corticosteroid therapy is indicated, except adrenal deficiency states.. prednisolone : A glucocorticoid that is prednisone in which the oxo group at position 11 has been reduced to the corresponding beta-hydroxy group. It is a drug metabolite of prednisone.		2.011011beta-hydroxy steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
drug metabolite;
environmental contaminant;
immunosuppressive agent;
xenobiotic
prednisone
Prednisone: A synthetic anti-inflammatory glucocorticoid derived from CORTISONE. It is biologically inert and converted to PREDNISOLONE in the liver.. prednisone : A synthetic glucocorticoid drug that is particularly effective as an immunosuppressant, and affects virtually all of the immune system. Prednisone is a prodrug that is converted by the liver into prednisolone (a beta-hydroxy group instead of the oxo group at position 11), which is the active drug and also a steroid.		2.071011-oxo steroid;
17alpha-hydroxy steroid;
20-oxo steroid;
21-hydroxy steroid;
3-oxo-Delta(1),Delta(4)-steroid;
C21-steroid;
glucocorticoid;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antineoplastic agent;
immunosuppressive agent;
prodrug
penicillin g
Penicillin G: A penicillin derivative commonly used in the form of its sodium or potassium salts in the treatment of a variety of infections. It is effective against most gram-positive bacteria and against gram-negative cocci. It has also been used as an experimental convulsant because of its actions on GAMMA-AMINOBUTYRIC ACID mediated synaptic transmission.. benzylpenicillin : A penicillin in which the substituent at position 6 of the penam ring is a phenylacetamido group.		2.0110penicillin allergen;
penicillin		antibacterial drug;
drug allergen;
epitope
pentylenetetrazole
Pentylenetetrazole: A pharmaceutical agent that displays activity as a central nervous system and respiratory stimulant. It is considered a non-competitive GAMMA-AMINOBUTYRIC ACID antagonist. Pentylenetetrazole has been used experimentally to study seizure phenomenon and to identify pharmaceuticals that may control seizure susceptibility.. pentetrazol : An organic heterobicyclic compound that is 1H-tetrazole in which the hydrogens at positions 1 and 5 are replaced by a pentane-1,5-diyl group. A central and respiratory stimulant, it was formerly used for the treatment of cough and other respiratory tract disorders, cardiovascular disorders including hypotension, and pruritis.		2.420organic heterobicyclic compound;
organonitrogen heterocyclic compound
carbostyril
Quinolones: A group of derivatives of naphthyridine carboxylic acid, quinoline carboxylic acid, or NALIDIXIC ACID.. quinolin-2(1H)-one : A quinolone that is 1,2-dihydroquinoline substituted by an oxo group at position 2.		2.4120monohydroxyquinoline;
quinolone		bacterial xenobiotic metabolite
methicillin
Methicillin: One of the PENICILLINS which is resistant to PENICILLINASE but susceptible to a penicillin-binding protein. It is inactivated by gastric acid so administered by injection.. methicillin : A penicillin that is 6-aminopenicillanic acid in which one of the amino hydrogens is replaced by a 2,6-dimethoxybenzoyl group.		2.6730penicillin allergen;
penicillin		antibacterial drug
cloxacillin
Cloxacillin: A semi-synthetic antibiotic that is a chlorinated derivative of OXACILLIN.. cloxacillin : A semisynthetic penicillin antibiotic carrying a 3-(2-chlorophenyl)-5-methylisoxazole-4-carboxamido group at position 6.		3.3511penicillin allergen;
penicillin;
semisynthetic derivative		antibacterial agent;
antibacterial drug
ampicillin
Ampicillin: Semi-synthetic derivative of penicillin that functions as an orally active broad-spectrum antibiotic.. ampicillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-phenylacetamido group.		6.5482beta-lactam antibiotic;
penicillin allergen;
penicillin		antibacterial drug
valine
Valine: A branched-chain essential amino acid that has stimulant activity. It promotes muscle growth and tissue repair. It is a precursor in the penicillin biosynthetic pathway.. valine : A branched-chain amino acid that consists of glycine in which one of the hydrogens attached to the alpha-carbon is substituted by an isopropyl group.. L-valine : The L-enantiomer of valine.		2.0210L-alpha-amino acid zwitterion;
L-alpha-amino acid;
proteinogenic amino acid;
pyruvate family amino acid;
valine		algal metabolite;
Escherichia coli metabolite;
human metabolite;
micronutrient;
mouse metabolite;
nutraceutical;
Saccharomyces cerevisiae metabolite
arginine
Arginine: An essential amino acid that is physiologically active in the L-form.. arginine : An alpha-amino acid that is glycine in which the alpha-is substituted by a 3-guanidinopropyl group.		1.9810arginine;
glutamine family amino acid;
L-alpha-amino acid;
proteinogenic amino acid		biomarker;
Escherichia coli metabolite;
micronutrient;
mouse metabolite;
nutraceutical
methylprednisolone
Methylprednisolone: A PREDNISOLONE derivative with similar anti-inflammatory action.. 6alpha-methylprednisolone : The 6alpha-stereoisomer of 6-methylprednisolone.		2.7306-methylprednisolone;
primary alpha-hydroxy ketone;
tertiary alpha-hydroxy ketone		adrenergic agent;
anti-inflammatory drug;
antiemetic;
environmental contaminant;
neuroprotective agent;
xenobiotic
penicillanic acid
Penicillanic Acid: A building block of penicillin, devoid of significant antibacterial activity. (From Merck Index, 11th ed). penicillanic acid : A penam that consists of 3,3-dimethyl-7-oxo-4-thia-1-azabicyclo[3.2.0]heptane bearing a carboxy group at position 2 and having (2S,5R)-configuration.		7.44178penicillanic acids
n-vinyl-2-pyrrolidinone
N-vinyl-2-pyrrolidinone: monomer of POVIDONE; structure given in first source		2.2510pyrrolidin-2-ones
fusarium
Fusarium: A mitosporic Hypocreales fungal genus, various species of which are important parasitic pathogens of plants and a variety of vertebrates. Teleomorphs include GIBBERELLA.		1.9710
erythromycin
Erythromycin: A bacteriostatic antibiotic macrolide produced by Streptomyces erythreus. Erythromycin A is considered its major active component. In sensitive organisms, it inhibits protein synthesis by binding to 50S ribosomal subunits. This binding process inhibits peptidyl transferase activity and interferes with translocation of amino acids during translation and assembly of proteins.. erythromycin : Any of several wide-spectrum macrolide antibiotics obtained from actinomycete Saccharopolyspora erythraea (formerly known as Streptomyces erythraeus).. erythromycin A : An erythromycin that consists of erythronolide A having 2,6-dideoxy-3-C-methyl-3-O-methyl-alpha-L-ribo-hexopyranosyl and 3,4,6-trideoxy-3-(dimethylamino)-beta-D-xylo-hexopyranosyl residues attahced at positions 4 and 6 respectively.		2.4220cyclic ketone;
erythromycin
zinc oxide
Zinc Oxide: A mild astringent and topical protectant with some antiseptic action. It is also used in bandages, pastes, ointments, dental cements, and as a sunblock.		2.1310zinc molecular entity
vancomycin
Vancomycin: Antibacterial obtained from Streptomyces orientalis. It is a glycopeptide related to RISTOCETIN that inhibits bacterial cell wall assembly and is toxic to kidneys and the inner ear.. vancomycin : A complex glycopeptide from Streptomyces orientalis. It inhibits a specific step in the synthesis of the peptidoglycan layer in the Gram-positive bacteria Staphylococcus aureus and Clostridium difficile.		7.32182glycopeptideantibacterial drug;
antimicrobial agent;
bacterial metabolite
carbenicillin
Carbenicillin: Broad-spectrum semisynthetic penicillin derivative used parenterally. It is susceptible to gastric juice and penicillinase and may damage platelet function.. carbenicillin : A penicillin antibiotic having a 6beta-2-carboxy-2-phenylacetamido side-chain.		1.9810penicillin allergen;
penicillin		antibacterial drug
zinc sulfate
Zinc Sulfate: A compound given in the treatment of conditions associated with zinc deficiency such as acrodermatitis enteropathica. Externally, zinc sulfate is used as an astringent in lotions and eye drops. (Reynolds JEF(Ed): Martindale: The Extra Pharmacopoeia (electronic version). Micromedex, Inc, Englewood, CO, 1995). zinc sulfate : A metal sulfate compound having zinc(2+) as the counterion.		2.3110metal sulfate;
zinc molecular entity		fertilizer
cephalexin
Cephalexin: A semisynthetic cephalosporin antibiotic with antimicrobial activity similar to that of CEPHALORIDINE or CEPHALOTHIN, but somewhat less potent. It is effective against both gram-positive and gram-negative organisms.. cephalexin : A semisynthetic first-generation cephalosporin antibiotic having methyl and beta-(2R)-2-amino-2-phenylacetamido groups at the 3- and 7- of the cephem skeleton, respectively. It is effective against both Gram-negative and Gram-positive organisms, and is used for treatment of infections of the skin, respiratory tract and urinary tract.		1.9810beta-lactam antibiotic allergen;
cephalosporin;
semisynthetic derivative		antibacterial drug
cefazolin
Cefazolin: A semisynthetic cephalosporin analog with broad-spectrum antibiotic action due to inhibition of bacterial cell wall synthesis. It attains high serum levels and is excreted quickly via the urine.. cefazolin : A first-generation cephalosporin compound having [(5-methyl-1,3,4-thiadiazol-2-yl)sulfanyl]methyl and (1H-tetrazol-1-ylacetyl)amino side-groups at positions 3 and 7 respectively.		4.0631beta-lactam antibiotic allergen;
cephalosporin;
tetrazoles;
thiadiazoles		antibacterial drug
amoxicillin
Amoxicillin: A broad-spectrum semisynthetic antibiotic similar to AMPICILLIN except that its resistance to gastric acid permits higher serum levels with oral administration.. amoxicillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-amino-2-(4-hydroxyphenyl)acetamido group.		4.8542penicillin allergen;
penicillin		antibacterial drug
4-ethynylbiphenyl
4-ethynylbiphenyl: structure given in first source		2.0110
sisomicin
Sisomicin: Antibiotic produced by Micromonospora inyoensis. It is closely related to gentamicin C1A, one of the components of the gentamicin complex (GENTAMICINS).		3.4110amino cyclitol glycoside;
aminoglycoside antibiotic;
beta-L-arabinoside;
monosaccharide derivative
tobramycin
Tobramycin: An aminoglycoside, broad-spectrum antibiotic produced by Streptomyces tenebrarius. It is effective against gram-negative bacteria, especially the PSEUDOMONAS species. It is a 10% component of the antibiotic complex, NEBRAMYCIN, produced by the same species.. tobramycin : A amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring.		6103amino cyclitol glycosideantibacterial agent;
antimicrobial agent;
toxin
ticarcillin
Ticarcillin: An antibiotic derived from penicillin similar to CARBENICILLIN in action.. ticarcillin : A penicillin compound having a 6beta-[(2R)-2-carboxy-2-thiophen-3-ylacetyl]amino side-group.		4.3322penicillin allergen;
penicillin		antibacterial drug
amikacin
Amikacin: A broad-spectrum antibiotic derived from KANAMYCIN. It is reno- and oto-toxic like the other aminoglycoside antibiotics.. amikacin : An amino cyclitol glycoside that is kanamycin A acylated at the N-1 position by a 4-amino-2-hydroxybutyryl group.		6.72164alpha-D-glucoside;
amino cyclitol glycoside;
aminoglycoside;
carboxamide		antibacterial drug;
antimicrobial agent;
nephrotoxin
torsemide
Torsemide: A pyridine and sulfonamide derivative that acts as a sodium-potassium chloride symporter inhibitor (loop diuretic). It is used for the treatment of EDEMA associated with CONGESTIVE HEART FAILURE; CHRONIC RENAL INSUFFICIENCY; and LIVER DISEASES. It is also used for the management of HYPERTENSION.. torasemide : An N-sulfonylurea obtained by formal condensation of [(3-methylphenyl)amino]pyridine-3-sulfonic acid with the free amino group of N-isopropylurea. It is a potent loop diuretic used for the treatment of hypertension and edema in patients with congestive heart failure.		1.9710aminopyridine;
N-sulfonylurea;
secondary amino compound		antihypertensive agent;
loop diuretic
cefmetazole
Cefmetazole: A semisynthetic cephamycin antibiotic with a broad spectrum of activity against both gram-positive and gram-negative microorganisms. It has a high rate of efficacy in many types of infection and to date no severe side effects have been noted.. cefmetazole : A second-generation cephalosporin antibiotic having N(1)-methyltetrazol-5-ylthiomethyl, {[(cyanomethyl)sulfanyl]acetyl}amino and methoxy side-groups at positions 3, 7beta and 7alpha respectively of the parent cephem bicyclic structure.		1.9710cephalosporinantibacterial drug
piperacillin
Piperacillin: Semisynthetic, broad-spectrum, AMPICILLIN derived ureidopenicillin antibiotic proposed for PSEUDOMONAS infections. It is also used in combination with other antibiotics.. piperacillin : A penicillin in which the substituent at position 6 of the penam ring is a 2-[(4-ethyl-2,3-dioxopiperazin-1-yl)carboxamido]-2-phenylacetamido group.		7.83239penicillin allergen;
penicillin		antibacterial drug
cefoperazone
Cefoperazone: Semisynthetic broad-spectrum cephalosporin with a tetrazolyl moiety that is resistant to beta-lactamase. It may be used to treat Pseudomonas infections.. cefoperazone : A semi-synthetic parenteral cephalosporin with a tetrazolyl moiety that confers beta-lactamase resistance.		4.7871cephalosporinantibacterial drug
moxalactam
Moxalactam: Broad- spectrum beta-lactam antibiotic similar in structure to the CEPHALOSPORINS except for the substitution of an oxaazabicyclo moiety for the thiaazabicyclo moiety of certain CEPHALOSPORINS. It has been proposed especially for the meningitides because it passes the blood-brain barrier and for anaerobic infections.. moxalactam : A broad-spectrum oxacephem antibiotic in which the oxazine ring is substituted with a tetrazolylthiomethyl group and the azetidinone ring carries methoxy and 2-carboxy-2-(4-hydroxyphenyl)acetamido substituents.		3.7721cephalosporin;
oxacephem		antibacterial drug
cefotetan
Cefotetan: A semisynthetic cephamycin antibiotic that is administered intravenously or intramuscularly. The drug is highly resistant to a broad spectrum of beta-lactamases and is active against a wide range of both aerobic and anaerobic gram-positive and gram-negative microorganisms.. cefotetan : A semi-synthetic second-generation cephamycin antibiotic with [(1-methyl-1H-tetrazol-5-yl)sulfanyl]methyl, methoxy and {[4-(2-amino-1-carboxy-2-oxoethylidene)-1,3-dithietan-2-yl]carbonyl}amino groups at the 3, 7alpha, and 7beta positions, respectively, of the cephem skeleton. It is resistant to a wide range of beta-lactamases and is active against a broad spectrum of aerobic and anaerobic Gram-positive and Gram-negative microorganisms.		1.9710
temafloxacin
temafloxacin: structure given in first source. temafloxacin : A racemate comprising equimolar amounts of (R)- and (S)-temafloxacin. Both enantiomers both exhibit similar pharmacological profiles. Temafloxacin was briefly used (either as the free base or as the hydrochloride salt) as an antibacterial drug but was withdrawn worldwide in 1992 following reports of serious side effects, including severe hypoglycaemia, haemolytic anaemia, liver and kidney dysfunction, anaphylaxis, and death.. 1-(2,4-difluorophenyl)-6-fluoro-7-(3-methylpiperazin-1-yl)-4-oxo-1,4-dihydroquinoline-3-carboxylic acid : A quinolone that is 4-oxo-1,4-dihydroquinoline-3-carboxylic acid which is substituted at positions 1, 6, and 7 by 2,4-difluorophenyl, fluorine, and 3-methylpiperazin-1-yl groups, respectively.		2.0110amino acid;
monocarboxylic acid;
N-arylpiperazine;
organofluorine compound;
quinolone antibiotic;
quinolone;
secondary amino compound;
tertiary amino compound
clinafloxacin
clinafloxacin: structure given in first source; RN given is for monoHCl		1.9910quinolines
sparfloxacin
[no description available]		2.0110fluoroquinolone antibiotic;
N-arylpiperazine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone
remacemide
remacemide: structure given in first source		2.0210stilbenoid
cephalosporin c
cephalosporin C: RN given refers to parent cpd; structure in Merck, 9th ed, #1937. cephalosporin C : A cephalosporin antibiotic carrying a 3-acetoxymethyl substituent and a 6-oxo-N(6)-L-lysino group at position 7.		11.32215cephalosporinfungal metabolite
ritipenem
ritipenem: carbapenem antibiotic; structure given in first source		3.3611
flomoxef
flomoxef: structure given in first source; RN given refers to sodium salt. flomoxef : A second-generation oxacephem antibiotic in which the oxazine ring is substituted at C-3 with a hydroxyethyl-substituted tetrazolylthiomethyl group and the azetidinone ring carries 7alpha-methoxy and 7beta-{2-[(difluoromethyl)thiomethyl]acetamido} substituents.		2.3920N-acyl-amino acid;
organonitrogen heterocyclic antibiotic;
oxacephem		antibacterial drug
pazufloxacin
[no description available]		2.7230quinolines
cefpimizole
cefpimizole: semisynthetic cephalosporin		1.9910peptide
sertraline
Sertraline: A selective serotonin uptake inhibitor that is used in the treatment of depression.. sertraline : A member of the class of tetralins that is tetralin which is substituted at positions 1 and 4 by a methylamino and a 3,4-dichlorophenyl group, respectively (the S,S diastereoisomer). A selective serotonin-reuptake inhibitor (SSRI), it is administered orally as the hydrochloride salt as an antidepressant for the treatment of depression, obsessive-compulsive disorder, panic disorder and post-traumatic stress disorder.		2.0310dichlorobenzene;
secondary amino compound;
tetralins		antidepressant;
serotonin uptake inhibitor
morpholinopropane sulfonic acid
3-(N-morpholino)propanesulfonic acid : A Good's buffer substance, pKa = 7.2 at 20 degreeC.		1.9810MOPS;
morpholines;
organosulfonic acid
ljc 10627
biapenem: structure given in first source. biapenem : A carbapenem antibiotic in which the azetidine and pyrroline rings carry 1-hydroxymethyl and pyrazolo[1,2-a][1,2,4]triazolium-6-ylthio substituents respectively.		5.6351carbapenems;
organic sulfide;
pyrazolotriazole		antibacterial drug
aspoxicillin
aspoxicillin: structure given in first source		1.9810peptide
doripenem
Doripenem: A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of infections such as HOSPITAL-ACQUIRED PNEUMONIA, and complicated intra-abdominal or urinary-tract infections, including PYELONEPHRITIS.		6.6661carbapenems
oxazolidin-2-one
Oxazolidinones: Derivatives of oxazolidin-2-one. They represent an important class of synthetic antibiotic agents.. oxazolidin-2-one : An oxazolidinone that is 1,3-oxazolidine with an oxo substituent at position 2.. oxazolidinone : An oxazolidine containing one or more oxo groups.		2.0810carbamate ester;
oxazolidinone		metabolite
clarithromycin
Clarithromycin: A semisynthetic macrolide antibiotic derived from ERYTHROMYCIN that is active against a variety of microorganisms. It can inhibit PROTEIN SYNTHESIS in BACTERIA by reversibly binding to the 50S ribosomal subunits. This inhibits the translocation of aminoacyl transfer-RNA and prevents peptide chain elongation.. clarithromycin : The 6-O-methyl ether of erythromycin A, clarithromycin is a macrolide antibiotic used in the treatment of respiratory-tract, skin and soft-tissue infections. It is also used to eradicate Helicobacter pylori in the treatment of peptic ulcer disease. It prevents bacteria from growing by interfering with their protein synthesis.		5.0691macrolide antibioticantibacterial drug;
environmental contaminant;
protein synthesis inhibitor;
xenobiotic
imipenem, anhydrous
Imipenem: Semisynthetic thienamycin that has a wide spectrum of antibacterial activity against gram-negative and gram-positive aerobic and anaerobic bacteria, including many multiresistant strains. It is stable to beta-lactamases. Clinical studies have demonstrated high efficacy in the treatment of infections of various body systems. Its effectiveness is enhanced when it is administered in combination with CILASTATIN, a renal dipeptidase inhibitor.. imipenem : A broad-spectrum, intravenous beta-lactam antibiotic of the carbapenem subgroup.		20.01398123beta-lactam antibiotic allergen;
carbapenems;
zwitterion		antibacterial drug
panipenem-betamipron
panipenem-betamipron: useful perenteral antibiotic against respiratory tract infections; structure given in first source		6.1191
tazobactam
Tazobactam: A penicillanic acid and sulfone derivative and potent BETA-LACTAMASE inhibitor that enhances the activity of other anti-bacterial agents against beta-lactamase producing bacteria.. tazobactam : A member of the class of penicillanic acids that is sulbactam in which one of the exocyclic methyl hydrogens is replaced by a 1,2,3-triazol-1-yl group; used (in the form of its sodium salt) in combination with ceftolozane sulfate for treatment of complicated intra-abdominal infections and complicated urinary tract infections.		7.5874penicillanic acids;
triazoles		antiinfective agent;
antimicrobial agent;
EC 3.5.2.6 (beta-lactamase) inhibitor
sulbactam
[no description available]		4.7590penicillanic acids
omega-n-methylarginine
omega-N-Methylarginine: A competitive inhibitor of nitric oxide synthetase.. N(omega)-methyl-L-arginine : A L-arginine derivative with a N(omega)-methyl substituent.		1.9810amino acid zwitterion;
arginine derivative;
guanidines;
L-arginine derivative;
non-proteinogenic L-alpha-amino acid
carbapenems
[no description available]		10.1296
beta-lactams
2-azetidinone: structure in first source. azetidin-2-one : An unsubstituted beta-lactam compound.. beta-lactam : A lactam in which the amide bond is contained within a four-membered ring, which includes the amide nitrogen and the carbonyl carbon.		6.13120beta-lactam antibiotic allergen;
beta-lactam
levofloxacin
Levofloxacin: The L-isomer of Ofloxacin.. levofloxacin : An optically active form of ofloxacin having (S)-configuration; an inhibitor of bacterial topoisomerase IV and DNA gyrase.		7.22929-fluoro-3-methyl-10-(4-methylpiperazin-1-yl)-7-oxo-2,3-dihydro-7H-[1,4]oxazino[2,3,4-ij]quinoline-6-carboxylic acid;
fluoroquinolone antibiotic;
quinolone antibiotic		antibacterial drug;
DNA synthesis inhibitor;
EC 5.99.1.3 [DNA topoisomerase (ATP-hydrolysing)] inhibitor;
topoisomerase IV inhibitor
ertapenem
Ertapenem: A carbapenem derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of Gram-positive and Gram-negative bacterial infections including intra-abdominal infections, acute gynecological infections, complicated urinary tract infections, skin infections, and respiratory tract infections. It is also used to prevent infection in colorectal surgery.. ertapenem : Meropenem in which the one of the two methyl groups attached to the amide nitrogen is replaced by hydrogen while the other is replaced by a 3-carboxyphenyl group. The sodium salt is used for the treatment of moderate to severe susceptible infections including intra-abdominal and acute gynaecological infections, pneumonia, and infections of the skin and of the urinary tract.		4.9360carbapenemcarboxylic acid;
pyrrolidinecarboxamide		antibacterial drug
moxifloxacin
Moxifloxacin: A fluoroquinolone that acts as an inhibitor of DNA TOPOISOMERASE II and is used as a broad-spectrum antibacterial agent.. moxifloxacin : A quinolone that consists of 4-oxo-1,4-dihydroquinoline-3-carboxylic acid bearing a cyclopropyl substituent at position 1, a fluoro substitiuent at position 6, a (4aS,7aS)-octahydro-6H-pyrrolo[3,4-b]pyridin-6-yl group at position 7 and a methoxy substituent at position 8. A member of the fluoroquinolone class of antibacterial agents.		2.4620aromatic ether;
cyclopropanes;
fluoroquinolone antibiotic;
pyrrolidinopiperidine;
quinolinemonocarboxylic acid;
quinolone antibiotic;
quinolone		antibacterial drug
colistimethate sodium
[no description available]		2.0710
trimethoprim, sulfamethoxazole drug combination
Trimethoprim, Sulfamethoxazole Drug Combination: A drug combination with broad-spectrum antibacterial activity against both gram-positive and gram-negative organisms. It is effective in the treatment of many infections, including PNEUMOCYSTIS PNEUMONIA in AIDS.. co-trimoxazole : A two-component mixture comprising trimethoprim and sulfamethoxazole.		4.5251
epiglucan
epiglucan: a highly side-chain/branched alkali-insoluble cell wall glucan from fungus such as Epicoccum nigrum, Botrytis cinerea, ascomycetes & basidiomycetes; also isolated S-4001 from Lei Wan (polyporus mylitiae), HA-beta-glucan from mushroom Pleutotus ostreatus (Fr.) Quel., and translam from seaweed Laminaria cichorioides; with commercially important functional properties including emulsification and friction reduction.		2.2510
meropenem
Meropenem: A thienamycin derivative antibacterial agent that is more stable to renal dehydropeptidase I than IMIPENEM, but does not need to be given with an enzyme inhibitor such as CILASTATIN. It is used in the treatment of bacterial infections, including infections in immunocompromised patients.. meropenem : A carbapenemcarboxylic acid in which the azetidine and pyrroline rings carry 1-hydroxymethyl and in which the azetidine and pyrroline rings carry 1-hydroxymethyl and 5-(dimethylcarbamoyl)pyrrolidin-3-ylthio substituents respectively.		12.824212alpha,beta-unsaturated monocarboxylic acid;
carbapenemcarboxylic acid;
organic sulfide;
pyrrolidinecarboxamide		antibacterial agent;
antibacterial drug;
drug allergen
cefoxitin
Cefoxitin: A semisynthetic cephamycin antibiotic resistant to beta-lactamase.. cefoxitin : A semisynthetic cephamycin antibiotic which, in addition to the methoxy group at the 7alpha position, has 2-thienylacetamido and carbamoyloxymethyl side-groups. It is resistant to beta-lactamase.		2.730beta-lactam antibiotic allergen;
cephalosporin;
cephamycin;
semisynthetic derivative		antibacterial drug
netilmicin
Netilmicin: Semisynthetic 1-N-ethyl derivative of SISOMYCIN, an aminoglycoside antibiotic with action similar to gentamicin, but less ear and kidney toxicity.		210
linezolid
[no description available]		2.0810acetamides;
morpholines;
organofluorine compound;
oxazolidinone		antibacterial drug;
protein synthesis inhibitor
sultamicillin
sultamicillin: contains ampicillin & sulbactam		4.0140penicillanic acid ester
clindamycin
Clindamycin: An antibacterial agent that is a semisynthetic analog of LINCOMYCIN.. clindamycin : A carbohydrate-containing antibiotic that is the semisynthetic derivative of lincomycin, a natural antibiotic.		6.63106
fosfomycin
Fosfomycin: An antibiotic produced by Streptomyces fradiae.. fosfomycin : A phosphonic acid having an (R,S)-1,2-epoxypropyl group attached to phosphorus.		4.3760epoxide;
phosphonic acids		antimicrobial agent;
EC 2.5.1.7 (UDP-N-acetylglucosamine 1-carboxyvinyltransferase) inhibitor
zithromax
Azithromycin: A semi-synthetic macrolide antibiotic structurally related to ERYTHROMYCIN. It has been used in the treatment of Mycobacterium avium intracellulare infections, toxoplasmosis, and cryptosporidiosis.. azithromycin : A macrolide antibiotic useful for the treatment of bacterial infections.		2.1310macrolide antibioticantibacterial drug;
environmental contaminant;
xenobiotic
cefamandole
Cefamandole: Semisynthetic wide-spectrum cephalosporin with prolonged action, probably due to beta-lactamase resistance. It is used also as the nafate.. cefamandole : A cephalosporin compound having (R)-mandelamido and N-methylthiotetrazole side-groups.		1.9710cephalosporin;
semisynthetic derivative		antibacterial drug
micafungin
Micafungin: A cyclic lipo-hexapeptide echinocandin antifungal agent that is used for the treatment and prevention of CANDIDIASIS.. micafungin : A cyclic hexapeptide echinocandin antibiotic which exerts its effect by inhibiting the synthesis of 1,3-beta-D-glucan, an integral component of the fungal cell wall. It is used as the sodium salt for the treatment of invasive candidiasis, and of aspergillosis in patients who are intolerant of other therapy.		2.5320antibiotic antifungal drug;
echinocandin		antiinfective agent
mezlocillin
Mezlocillin: Semisynthetic ampicillin-derived acylureido penicillin. It has been proposed for infections with certain anaerobes and may be useful in inner ear, bile, and CNS infections.. mezlocillin : A penicillin in which the substituent at position 6 of the penam ring is a (2R)-2-[3-(methanesulfonyl)-2-oxoimidazolidine-1-carboxamido]-2-phenylacetamido group.		3.3511penicillin allergen;
penicillin		antibacterial drug
isepamicin
[no description available]		2.3920
alprostadil
[no description available]		3.3811prostaglandins Eanticoagulant;
human metabolite;
platelet aggregation inhibitor;
vasodilator agent
nalbuphine
Nalbuphine: A narcotic used as a pain medication. It appears to be an agonist at KAPPA RECEPTORS and an antagonist or partial agonist at MU RECEPTORS.		1.9710organic heteropentacyclic compoundmu-opioid receptor antagonist;
opioid analgesic
barium
Barium: An element of the alkaline earth group of metals. It has an atomic symbol Ba, atomic number 56, and atomic weight 138. All of its acid-soluble salts are poisonous.		2.0710alkaline earth metal atom;
elemental barium
cefodizime
cefodizime: RN given refers to (6R-(6alpha,7beta(Z)))-isomer. cefodizime : A cephalosporin compound having 5-(carboxymethyl)-4-methyl-1,3-thiazol-2-yl]sulfanyl}methyl and [2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino side groups located at positions 3 and 7 respectively.		1.97101,3-thiazoles;
cephalosporin;
oxime O-ether		antibacterial drug;
EC 1.14.18.1 (tyrosinase) inhibitor
cefepime
Cefepime: A fourth-generation cephalosporin antibacterial agent that is used in the treatment of infections, including those of the abdomen, urinary tract, respiratory tract, and skin. It is effective against PSEUDOMONAS AERUGINOSA and may also be used in the empiric treatment of FEBRILE NEUTROPENIA.. cefepime : A cephalosporin bearing (1-methylpyrrolidinium-1-yl)methyl and (2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetamido groups at positions 3 and 7, respectively, of the cephem skeleton.		6.6873cephalosporin;
oxime O-ether		antibacterial drug
cefotaxime
Cefotaxime: Semisynthetic broad-spectrum cephalosporin.. cefotaxime : A cephalosporin compound having acetoxymethyl and [2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino side groups.		4.78711,3-thiazoles;
cephalosporin;
oxime O-ether		antibacterial drug;
drug allergen
cilastatin
[no description available]		19.93396122carboxamide;
L-cysteine derivative;
non-proteinogenic L-alpha-amino acid;
organic sulfide		EC 3.4.13.19 (membrane dipeptidase) inhibitor;
environmental contaminant;
protease inhibitor;
xenobiotic
brl 28500
ticarcillin-clavulanic acid: combination of ticarcillin and clavulanic acid; used against gram-negative rods		4.3322
morphinans
Morphinans: Compounds based on a partially saturated iminoethanophenanthrene, which can be described as ethylimino-bridged benzo-decahydronaphthalenes. They include some of the OPIOIDS found in PAPAVER that are used as ANALGESICS.		1.9710isoquinoline alkaloid fundamental parent;
morphinane alkaloid
fce 22891
FCE 22891: structure in first source		3.3611
tebipenem
tebipenem: an oral carbapenem antibiotic, against penicillin-nonsusceptible Streptococcus pneumoniae; structure in first source		2.0510
amoxicillin-potassium clavulanate combination
Amoxicillin-Potassium Clavulanate Combination: A fixed-ratio combination of amoxicillin trihydrate and potassium clavulanate.		3.5110
avibactam
avibactam : A member of the class of azabicycloalkanes that is (2S,5R)-7-oxo-1,6-diazabicyclo[3.2.1]octane-2-carboxamide in which the amino hydrogen at position 6 is replaced by a sulfooxy group. Used (in the form of its sodium salt) in combination with ceftazidime pentahydrate for the treatment of complicated urinary tract infections including pyelonephritis.		3.3110azabicycloalkane;
hydroxylamine O-sulfonic acid;
monocarboxylic acid amide;
ureas		antibacterial drug;
antimicrobial agent;
EC 3.5.2.6 (beta-lactamase) inhibitor
chitosan
[no description available]		2.1310
ro13-9904
Ceftriaxone: A broad-spectrum cephalosporin antibiotic and cefotaxime derivative with a very long half-life and high penetrability to meninges, eyes and inner ears.. ceftriaxone : A third-generation cephalosporin compound having 2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetylamino and [(2-methyl-5,6-dioxo-1,2,5,6-tetrahydro-1,2,4-triazin-3-yl)sulfanyl]methyl side-groups.		6.27104
piperacillin, tazobactam drug combination
Piperacillin, Tazobactam Drug Combination: An antibiotic combination product of piperacillin and tazobactam, a penicillanic acid derivative with enhanced beta-lactamase inhibitory activity, that is used for the intravenous treatment of intra-abdominal, pelvic, and skin infections and for community-acquired pneumonia of moderate severity. It is also used for the treatment of PSEUDOMONAS AERUGINOSA INFECTIONS.		6.84174
achn 490
plazomicin: structure in first source		3.4110
mk-7655
relebactam: structure in first source		10.83135
colistin
Colistin: Cyclic polypeptide antibiotic from Bacillus colistinus. It is composed of Polymyxins E1 and E2 (or Colistins A, B, and C) which act as detergents on cell membranes. Colistin is less toxic than Polymyxin B, but otherwise similar; the methanesulfonate is used orally.. colistin : A multi-component mixture comprising mostly of colistin A (R = Me) and B (R = H), with small amounts of colistin C and other polymyxins, produced by certain strains of Bacillus polymyxa var. colistinus. An antibiotic, it is used as its sulfate salt (for oral or topical use) or as the sodium salt of the N-methylsulfonic acid derivative (the injectable form) in the treatment of severe Gram-negative infections, partiularly those due to Pseudomonas aeruginosa.		6.1152
minocycline
Minocycline: A TETRACYCLINE analog, having a 7-dimethylamino and lacking the 5 methyl and hydroxyl groups, which is effective against tetracycline-resistant STAPHYLOCOCCUS infections.. minocycline : A tetracycline analogue having a dimethylamino group at position 7 and lacking the methyl and hydroxy groups at position 5.		11.16219
tigecycline
[no description available]		9.47119
omadacycline
omadacycline: demonstrated in vitro activity against a broad range of Gram-positive and select Gram-negative pathogens; structure in first source		3.4110tetracyclines
eravacycline
eravacycline: has antibacterial activity		3.4110tetracyclines
cefiderocol
cefiderocol: structure in first source. cefiderocol : A fourth-generation siderophore cephalosporin antibiotic having {1-[2-(2-chloro-3,4-dihydroxybenzamido)ethyl]pyrrolidinium-1-yl}methyl and [(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-{[(2-carboxypropan-2-yl)oxy]imino}acetyl]amino side groups located at positions 3 and 7 respectively, developed to combat a variety of bacterial pathogens, including beta-lactam- and carbapenem-resistant organisms.		7.9781carboxylic acid;
cephalosporin		antibacterial drug;
siderophore
clozapine
Clozapine: A tricylic dibenzodiazepine, classified as an atypical antipsychotic agent. It binds several types of central nervous system receptors, and displays a unique pharmacological profile. Clozapine is a serotonin antagonist, with strong binding to 5-HT 2A/2C receptor subtype. It also displays strong affinity to several dopaminergic receptors, but shows only weak antagonism at the dopamine D2 receptor, a receptor commonly thought to modulate neuroleptic activity. Agranulocytosis is a major adverse effect associated with administration of this agent.. clozapine : A benzodiazepine that is 5H-dibenzo[b,e][1,4]diazepine substituted by a chloro group at position 8 and a 4-methylpiperazin-1-yl group at position 11. It is a second generation antipsychotic used in the treatment of psychiatric disorders like schizophrenia.		1.9910benzodiazepine;
N-arylpiperazine;
N-methylpiperazine;
organochlorine compound		adrenergic antagonist;
dopaminergic antagonist;
EC 3.4.21.26 (prolyl oligopeptidase) inhibitor;
environmental contaminant;
GABA antagonist;
histamine antagonist;
muscarinic antagonist;
second generation antipsychotic;
serotonergic antagonist;
xenobiotic
dactinomycin
cefozopran: RN given refers to the (6R-(6alpha,7beta(Z)))-isomer; RN for cpd without isomeric designation not available 10/91. cefozopran : A fourth-generation cephalosporin antibiotic having imidazo[1,2-b]pyridazin-1-ium-1-ylmethyl and [(2Z)-2-(2-amino-1,3-thiazol-4-yl)-2-(methoxyimino)acetyl]amino side groups located at positions 3 and 7 respectively.		4.7521
ConditionIndicatedRelationship StrengthStudiesTrials
Low Back Ache
[description not available]		02.3110
Low Back Pain
Acute or chronic pain in the lumbar or sacral regions, which may be associated with musculo-ligamentous SPRAINS AND STRAINS; INTERVERTEBRAL DISK DISPLACEMENT; and other conditions.		02.3110
Critical Illness
A disease or state in which death is possible or imminent.		03.4670
Bacterial Disease
[description not available]		016.4112160
Thrombopenia
[description not available]		03.3920
Bacterial Infections
Infections by bacteria, general or unspecified.		016.4112160
Thrombocytopenia
A subnormal level of BLOOD PLATELETS.		03.3920
Infective Endocarditis
[description not available]		02.4110
E coli Infections
[description not available]		03.79110
Endocarditis
Inflammation of the inner lining of the heart (ENDOCARDIUM), the continuous membrane lining the four chambers and HEART VALVES. It is often caused by microorganisms including bacteria, viruses, fungi, and rickettsiae. Left untreated, endocarditis can damage heart valves and become life-threatening.		02.4110
Escherichia coli Infections
Infections with bacteria of the species ESCHERICHIA COLI.		03.79110
Urinary Tract Infections
Inflammatory responses of the epithelium of the URINARY TRACT to microbial invasions. They are often bacterial infections with associated BACTERIURIA and PYURIA.		011.26259
Ventilator-Associated Pneumonia
[description not available]		0693
2019 Novel Coronavirus Disease
[description not available]		02.4110
Pneumonia, Ventilator-Associated
Serious INFLAMMATION of the LUNG in patients who required the use of PULMONARY VENTILATOR. It is usually caused by bacterial CROSS INFECTION in hospitals.		0693
Blood Poisoning
[description not available]		09.292813
Chronic Kidney Diseases
[description not available]		02.4110
Sepsis
Systemic inflammatory response syndrome with a proven or suspected infectious etiology. When sepsis is associated with organ dysfunction distant from the site of infection, it is called severe sepsis. When sepsis is accompanied by HYPOTENSION despite adequate fluid infusion, it is called SEPTIC SHOCK.		09.292813
Renal Insufficiency, Chronic
Conditions in which the KIDNEYS perform below the normal level for more than three months. Chronic kidney insufficiency is classified by five stages according to the decline in GLOMERULAR FILTRATION RATE and the degree of kidney damage (as measured by the level of PROTEINURIA). The most severe form is the end-stage renal disease (CHRONIC KIDNEY FAILURE). (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002)		02.4110
Bacillus anthracis Infection
[description not available]		03.3310
Anthrax
An acute infection caused by the spore-forming bacteria BACILLUS ANTHRACIS. It commonly affects hoofed animals such as sheep and goats. Infection in humans often involves the skin (cutaneous anthrax), the lungs (inhalation anthrax), or the gastrointestinal tract. Anthrax is not contagious and can be treated with antibiotics.		03.3310
Osteoarthritis of Knee
[description not available]		02.8220
Ache
[description not available]		02.8220
Pain
An unpleasant sensation induced by noxious stimuli which are detected by NERVE ENDINGS of NOCICEPTIVE NEURONS.		02.8220
Osteoarthritis, Knee
Noninflammatory degenerative disease of the knee joint consisting of three large categories: conditions that block normal synchronous movement, conditions that produce abnormal pathways of motion, and conditions that cause stress concentration resulting in changes to articular cartilage. (Crenshaw, Campbell's Operative Orthopaedics, 8th ed, p2019)		02.8220
Shoulder Pain
Unilateral or bilateral pain of the shoulder. It is often caused by physical activities such as work or sports participation, but may also be pathologic in origin.		03.0120
Bacterial Pneumonia
[description not available]		06.47124
Pneumonia, Bacterial
Inflammation of the lung parenchyma that is caused by bacterial infections.		06.47124
Joint Pain
[description not available]		04.4541
Arthritis, Degenerative
[description not available]		02.8220
Osteoarthritis
A progressive, degenerative joint disease, the most common form of arthritis, especially in older persons. The disease is thought to result not from the aging process but from biochemical changes and biomechanical stresses affecting articular cartilage. In the foreign literature it is often called osteoarthrosis deformans.		02.8220
Arthralgia
Pain in the joint.		04.4541
Atypical Mycobacterial Infection, Disseminated
[description not available]		03.5580
Abscess
Accumulation of purulent material in tissues, organs, or circumscribed spaces, usually associated with signs of infection.		05.9193
Acute Edematous Pancreatitis
[description not available]		06.9763
Experimental Lung Inflammation
Inflammation of any part, segment or lobe, of the lung parenchyma.		08.67127
Pancreatitis
INFLAMMATION of the PANCREAS. Pancreatitis is classified as acute unless there are computed tomographic or endoscopic retrograde cholangiopancreatographic findings of CHRONIC PANCREATITIS (International Symposium on Acute Pancreatitis, Atlanta, 1992). The two most common forms of acute pancreatitis are ALCOHOLIC PANCREATITIS and gallstone pancreatitis.		06.9763
Pneumonia
Infection of the lung often accompanied by inflammation.		08.67127
Co-infection
[description not available]		02.6120
Pleural Effusion
Presence of fluid in the pleural cavity resulting from excessive transudation or exudation from the pleural surfaces. It is a sign of disease and not a diagnosis in itself.		02.2110
Tongue, Hairy
A benign condition of the tongue characterized by hypertrophy of the filiform papillae that give the dorsum of the tongue a furry appearance. The color of the elongated papillae varies from yellowish white to brown or black, depending upon staining by substances such as tobacco, food, or drugs. (Dorland, 27th ed)		02.2510
Acinetobacter Infections
Infections with bacteria of the genus ACINETOBACTER.		03.6890
Intra-Abdominal Infections
[description not available]		07.5252
Intraabdominal Infections
Infection within the PERITONEAL CAVITY. A frequent cause is an ANASTOMOTIC LEAK following surgery.		07.5252
Hepatic Failure
[description not available]		03.1710
Complications, Infectious Pregnancy
[description not available]		04.0930
Pregnancy
The status during which female mammals carry their developing young (EMBRYOS or FETUSES) in utero before birth, beginning from FERTILIZATION to BIRTH.		07.03102
Liver Failure
Severe inability of the LIVER to perform its normal metabolic functions, as evidenced by severe JAUNDICE and abnormal serum levels of AMMONIA; BILIRUBIN; ALKALINE PHOSPHATASE; ASPARTATE AMINOTRANSFERASE; LACTATE DEHYDROGENASES; and albumin/globulin ratio. (Blakiston's Gould Medical Dictionary, 4th ed)		03.1710
Bacterial Infections, Gram-Negative
[description not available]		09.7115
Gram-Negative Bacterial Infections
Infections caused by bacteria that show up as pink (negative) when treated by the gram-staining method.		09.7115
Pyrexia
[description not available]		08.39169
Fever
An abnormal elevation of body temperature, usually as a result of a pathologic process.		08.39169
Neutropenia
A decrease in the number of NEUTROPHILS found in the blood.		07.952211
Burns
Injuries to tissues caused by contact with heat, steam, chemicals (BURNS, CHEMICAL), electricity (BURNS, ELECTRIC), or the like.		03.1950
Colorectal Cancer
[description not available]		02.2510
Cerebral Nocardiosis
[description not available]		02.9640
Colorectal Neoplasms
Tumors or cancer of the COLON or the RECTUM or both. Risk factors for colorectal cancer include chronic ULCERATIVE COLITIS; FAMILIAL POLYPOSIS COLI; exposure to ASBESTOS; and irradiation of the CERVIX UTERI.		02.2510
Cronobacter Infections
[description not available]		03.1350
Enterobacteriaceae Infections
Infections with bacteria of the family ENTEROBACTERIACEAE.		03.1350
Angiogenesis, Pathologic
[description not available]		02.3110
Acute Kidney Failure
[description not available]		04.6561
Acute Kidney Injury
Abrupt reduction in kidney function. Acute kidney injury encompasses the entire spectrum of the syndrome including acute kidney failure; ACUTE KIDNEY TUBULAR NECROSIS; and other less severe conditions.		04.6561
Arthropathies
[description not available]		02.3110
Joint Diseases
Diseases involving the JOINTS.		02.3110
Grippe
[description not available]		02.4820
Influenza, Human
An acute viral infection in humans involving the respiratory tract. It is marked by inflammation of the NASAL MUCOSA; the PHARYNX; and conjunctiva, and by headache and severe, often generalized, myalgia.		02.4820
Necrotizing Pyelonephritis
[description not available]		05.0131
Pyelonephritis
Inflammation of the KIDNEY involving the renal parenchyma (the NEPHRONS); KIDNEY PELVIS; and KIDNEY CALICES. It is characterized by ABDOMINAL PAIN; FEVER; NAUSEA; VOMITING; and occasionally DIARRHEA.		05.0131
Flavobacteriaceae Infections
Infections with bacteria of the family FLAVOBACTERIACEAE.		02.1510
Health Care Associated Infection
[description not available]		07.11147
Cross Infection
Any infection which a patient contracts in a health-care institution.		07.11147
Bacteremia
The presence of viable bacteria circulating in the blood. Fever, chills, tachycardia, and tachypnea are common acute manifestations of bacteremia. The majority of cases are seen in already hospitalized patients, most of whom have underlying diseases or procedures which render their bloodstreams susceptible to invasion.		06.03103
Infection
[description not available]		04.4951
Infections
Invasion of the host organism by microorganisms or their toxins or by parasites that can cause pathological conditions or diseases.		04.4951
Tendinitis
Inflammation of TENDONS. It is characterized by the degeneration of tendons accompanied by an inflammatory repair response, fibroblastic proliferation, and formation of granulation tissue. Tendinitis is not a clinical diagnosis and can be confirmed only by histopathological findings.		04.1831
Pain, Chronic
[description not available]		02.1710
Glenoid Labral Tears
[description not available]		02.1710
Calcification, Pathologic
[description not available]		02.1710
Epicondylitis, Lateral Humeral
[description not available]		02.1710
Rotator Cuff Injuries
Injuries to the ROTATOR CUFF of the shoulder joint.		02.1710
Calcinosis
Pathologic deposition of calcium salts in tissues.		02.1710
Tennis Elbow
A condition characterized by pain in or near the lateral humeral epicondyle or in the forearm extensor muscle mass as a result of unusual strain. It occurs due repetitive stresses on the elbow from activities such as tennis playing.		02.1710
Tendinopathy
Clinical syndrome describing overuse tendon injuries characterized by a combination of PAIN, diffuse or localized swelling, and impaired performance.		04.1831
Chronic Pain
Aching sensation that persists for more than a few months. It may or may not be associated with trauma or disease, and may persist after the initial injury has healed. Its localization, character, and timing are more vague than with acute pain.		02.1710
Urinary Lithiasis
[description not available]		02.1710
Kidney Diseases
Pathological processes of the KIDNEY or its component tissues.		03.1150
Urolithiasis
Formation of stones in any part of the URINARY TRACT, usually in the KIDNEY; URINARY BLADDER; or the URETER.		02.1710
Brain Hemorrhage, Cerebral
[description not available]		02.1710
Cerebral Hemorrhage
Bleeding into one or both CEREBRAL HEMISPHERES including the BASAL GANGLIA and the CEREBRAL CORTEX. It is often associated with HYPERTENSION and CRANIOCEREBRAL TRAUMA.		02.1710
Chronic Idiopathic Intestinal Pseudo-Obstruction
[description not available]		02.2110
Libman-Sacks Disease
[description not available]		02.4720
MODS
[description not available]		04.1331
Intestinal Pseudo-Obstruction
A type of ILEUS, a functional not mechanical obstruction of the INTESTINES. This syndrome is caused by a large number of disorders involving the smooth muscles (MUSCLE, SMOOTH) or the NERVOUS SYSTEM.		02.2110
Lupus Erythematosus, Systemic
A chronic, relapsing, inflammatory, and often febrile multisystemic disorder of connective tissue, characterized principally by involvement of the skin, joints, kidneys, and serosal membranes. It is of unknown etiology, but is thought to represent a failure of the regulatory mechanisms of the autoimmune system. The disease is marked by a wide range of system dysfunctions, an elevated erythrocyte sedimentation rate, and the formation of LE cells in the blood or bone marrow.		02.4720
Multiple Organ Failure
A progressive condition usually characterized by combined failure of several organs such as the lungs, liver, kidney, along with some clotting mechanisms, usually postinjury or postoperative.		04.1331
Acute Necrotizing Pancreatitis
[description not available]		06.7583
Hematochezia
The passage of bright red blood from the rectum. The blood may or may not be mixed with formed stool in the form of blood, blood clots, bloody stool or diarrhea.		02.2110
Infections, Klebsiella
[description not available]		03.5480
Cholecystoduodenal Fistula
[description not available]		02.2110
Gastrointestinal Hemorrhage
Bleeding in any segment of the GASTROINTESTINAL TRACT from ESOPHAGUS to RECTUM.		02.2110
Klebsiella Infections
Infections with bacteria of the genus KLEBSIELLA.		03.5480
Candidiasis, Invasive
An important nosocomial fungal infection with species of the genus CANDIDA, most frequently CANDIDA ALBICANS. Invasive candidiasis occurs when candidiasis goes beyond a superficial infection and manifests as CANDIDEMIA, deep tissue infection, or disseminated disease with deep organ involvement.		02.2110
Adverse Drug Event
[description not available]		04.8321
Drug-Related Side Effects and Adverse Reactions
Disorders that result from the intended use of PHARMACEUTICAL PREPARATIONS. Included in this heading are a broad variety of chemically-induced adverse conditions due to toxicity, DRUG INTERACTIONS, and metabolic effects of pharmaceuticals.		04.8321
Disease Models, Animal
Naturally-occurring or experimentally-induced animal diseases with pathological processes analogous to human diseases.		03.71100
Cancer of Esophagus
[description not available]		03.1210
Esophageal Neoplasms
Tumors or cancer of the ESOPHAGUS.		03.1210
Cystic Fibrosis of Pancreas
[description not available]		02.6930
Cystic Fibrosis
An autosomal recessive genetic disease of the EXOCRINE GLANDS. It is caused by mutations in the gene encoding the CYSTIC FIBROSIS TRANSMEMBRANE CONDUCTANCE REGULATOR expressed in several organs including the LUNG, the PANCREAS, the BILIARY SYSTEM, and the SWEAT GLANDS. Cystic fibrosis is characterized by epithelial secretory dysfunction associated with ductal obstruction resulting in AIRWAY OBSTRUCTION; chronic RESPIRATORY INFECTIONS; PANCREATIC INSUFFICIENCY; maldigestion; salt depletion; and HEAT PROSTRATION.		02.6930
Chronic Illness
[description not available]		05.262
Rheumatism
[description not available]		03.8721
Chronic Disease
Diseases which have one or more of the following characteristics: they are permanent, leave residual disability, are caused by nonreversible pathological alteration, require special training of the patient for rehabilitation, or may be expected to require a long period of supervision, observation, or care (Dictionary of Health Services Management, 2d ed). For epidemiological studies chronic disease often includes HEART DISEASES; STROKE; CANCER; and diabetes (DIABETES MELLITUS, TYPE 2).		05.262
Rheumatic Diseases
Disorders of connective tissue, especially the joints and related structures, characterized by inflammation, degeneration, or metabolic derangement.		03.8721
Phlegmon
[description not available]		04.6432
Orbital Diseases
Diseases of the bony orbit and contents except the eyeball.		02.0810
Cellulitis
An acute, diffuse, and suppurative inflammation of loose connective tissue, particularly the deep subcutaneous tissues, and sometimes muscle, which is most commonly seen as a result of infection of a wound, ulcer, or other skin lesions.		04.6432
Absence Seizure
[description not available]		09.37193
Seizures
Clinical or subclinical disturbances of cortical function due to a sudden, abnormal, excessive, and disorganized discharge of brain cells. Clinical manifestations include abnormal motor, sensory and psychic phenomena. Recurrent seizures are usually referred to as EPILEPSY or seizure disorder.		09.37193
Canine Diseases
[description not available]		02.0810
Infections, Pseudomonas
[description not available]		08.02182
Pseudomonas Infections
Infections with bacteria of the genus PSEUDOMONAS.		08.02182
Acute Cholecystitis
[description not available]		03.511
Acute Disease
Disease having a short and relatively severe course.		06.9165
Cholangitis
Inflammation of the biliary ductal system (BILE DUCTS); intrahepatic, extrahepatic, or both.		04.8742
Cholecystitis, Acute
Acute inflammation of the GALLBLADDER wall. It is characterized by the presence of ABDOMINAL PAIN; FEVER; and LEUKOCYTOSIS. Gallstone obstruction of the CYSTIC DUCT is present in approximately 90% of the cases.		03.511
Chemotherapy-Induced Febrile Neutropenia
FEVER accompanied by a significant reduction in NEUTROPHIL count associated with CHEMOTHERAPY.		04.4111
Eczema, Atopic
[description not available]		02.1110
Cardiac Failure
[description not available]		02.1110
Bacterial Endocarditides
[description not available]		02.9140
Dermatitis, Atopic
A chronic inflammatory genetically determined disease of the skin marked by increased ability to form reagin (IgE), with increased susceptibility to allergic rhinitis and asthma, and hereditary disposition to a lowered threshold for pruritus. It is manifested by lichenification, excoriation, and crusting, mainly on the flexural surfaces of the elbow and knee. In infants it is known as infantile eczema.		02.1110
Endocarditis, Bacterial
Inflammation of the ENDOCARDIUM caused by BACTERIA that entered the bloodstream. The strains of bacteria vary with predisposing factors, such as CONGENITAL HEART DEFECTS; HEART VALVE DISEASES; HEART VALVE PROSTHESIS IMPLANTATION; or intravenous drug use.		02.9140
Heart Failure
A heterogeneous condition in which the heart is unable to pump out sufficient blood to meet the metabolic need of the body. Heart failure can be caused by structural defects, functional abnormalities (VENTRICULAR DYSFUNCTION), or a sudden overload beyond its capacity. Chronic heart failure is more common than acute heart failure which results from sudden insult to cardiac function, such as MYOCARDIAL INFARCTION.		02.1110
Hypercapnia
A clinical manifestation of abnormal increase in the amount of carbon dioxide in arterial blood.		02.1110
Empyema, Thoracic
[description not available]		02.4920
Empyema, Pleural
Suppurative inflammation of the pleural space.		02.4920
Bites
[description not available]		02.4820
Infections, Pasteurella
[description not available]		02.1110
Endotoxin Shock
[description not available]		03.1250
Shock, Septic
Sepsis associated with HYPOTENSION or hypoperfusion despite adequate fluid resuscitation. Perfusion abnormalities may include but are not limited to LACTIC ACIDOSIS; OLIGURIA; or acute alteration in mental status.		03.1250
Infections, Mycobacterium
[description not available]		02.1310
Infection, Postoperative Wound
[description not available]		05.4582
Mycobacterium Infections
Infections with bacteria of the genus MYCOBACTERIUM.		02.1310
Disease, Pulmonary
[description not available]		02.9340
Lung Diseases
Pathological processes involving any part of the LUNG.		02.9340
Hematologic Malignancies
[description not available]		04.4122
Hematologic Neoplasms
Neoplasms located in the blood and blood-forming tissue (the bone marrow and lymphatic tissue). The commonest forms are the various types of LEUKEMIA, of LYMPHOMA, and of the progressive, life-threatening forms of the MYELODYSPLASTIC SYNDROMES.		04.4122
Febrile Neutropenia
Fever accompanied by a significant reduction in the number of NEUTROPHILS.		03.5111
Brain Disorders
[description not available]		02.1310
Benign Infantile Myoclonic Epilepsy
[description not available]		02.1310
Actinic Reticuloid Syndrome
[description not available]		02.1310
Brain Diseases
Pathologic conditions affecting the BRAIN, which is composed of the intracranial components of the CENTRAL NERVOUS SYSTEM. This includes (but is not limited to) the CEREBRAL CORTEX; intracranial white matter; BASAL GANGLIA; THALAMUS; HYPOTHALAMUS; BRAIN STEM; and CEREBELLUM.		02.1310
Epilepsies, Myoclonic
A clinically diverse group of epilepsy syndromes characterized either by myoclonic seizures or by myoclonus in association with other seizure types. Myoclonic epilepsy syndromes are divided into three subtypes based on etiology: familial, cryptogenic, and symptomatic.		02.1310
Macrophage Activation Syndrome
A serious complication of childhood systemic inflammatory disorders that is thought to be caused by excessive activation and proliferation of T-LYMPHOCYTES and MACROPHAGES. It is seen predominantly in children with systemic onset JUVENILE IDIOPATHIC ARTHRITIS.		02.1310
Eosinophilia, Pulmonary
[description not available]		02.1310
Pulmonary Eosinophilia
A condition characterized by infiltration of the lung with EOSINOPHILS due to inflammation or other disease processes. Major eosinophilic lung diseases are the eosinophilic pneumonias caused by infections, allergens, or toxic agents.		02.1310
Disease Exacerbation
[description not available]		05.0631
Mycoplasma dispar Infection
[description not available]		02.1310
Psychoses, Drug
[description not available]		02.1310
Graft-Versus-Host Disease
[description not available]		02.1310
Graft vs Host Disease
The clinical entity characterized by anorexia, diarrhea, loss of hair, leukopenia, thrombocytopenia, growth retardation, and eventual death brought about by the GRAFT VS HOST REACTION.		02.1310
Campylobacter Infection
[description not available]		03.3420
Infections, Soft Tissue
[description not available]		06.1775
Soft Tissue Infections
Infections of non-skeletal tissue, i.e., exclusive of bone, ligaments, cartilage, and fibrous tissue. The concept is usually referred to as skin and soft tissue infections and usually subcutaneous and muscle tissue are involved. The predisposing factors in anaerobic infections are trauma, ischemia, and surgery. The organisms often derive from the fecal or oral flora, particularly in wounds associated with intestinal surgery, decubitus ulcer, and human bites. (From Cecil Textbook of Medicine, 19th ed, p1688)		06.1775
Infection, Puerperal
[description not available]		04.2941
Embolism, Pulmonary
[description not available]		02.0410
Infections, Staphylococcal
[description not available]		06.73122
Phlegmasia Alba Dolens
Inflammation that is characterized by swollen, pale, and painful limb. It is usually caused by DEEP VEIN THROMBOSIS in a FEMORAL VEIN, following PARTURITION or an illness. This condition is also called milk leg or white leg.		02.0410
Pulmonary Embolism
Blocking of the PULMONARY ARTERY or one of its branches by an EMBOLUS.		02.0410
Staphylococcal Infections
Infections with bacteria of the genus STAPHYLOCOCCUS.		06.73122
Thrombophlebitis
Inflammation of a vein associated with a blood clot (THROMBUS).		02.0410
Clostridioides difficile Infection
[description not available]		02.0410
Clostridium Infections
Infections with bacteria of the genus CLOSTRIDIUM and closely related CLOSTRIDIOIDES species.		02.0410
Diabetic Feet
[description not available]		06.1362
Complications of Diabetes Mellitus
[description not available]		05.5661
Diabetic Foot
Common foot problems in persons with DIABETES MELLITUS, caused by any combination of factors such as DIABETIC NEUROPATHIES; PERIPHERAL VASCULAR DISEASES; and INFECTION. With the loss of sensation and poor circulation, injuries and infections often lead to severe foot ulceration, GANGRENE and AMPUTATION.		06.1362
Abscess, Abdominal
[description not available]		07.8555
Abdominal Abscess
An abscess located in the abdominal cavity, i.e., the cavity between the diaphragm above and the pelvis below. (From Dorland, 27th ed)		07.8555
Nervous System Disorders
[description not available]		02.9610
Nervous System Diseases
Diseases of the central and peripheral nervous system. This includes disorders of the brain, spinal cord, cranial nerves, peripheral nerves, nerve roots, autonomic nervous system, neuromuscular junction, and muscle.		02.9610
Fungal Diseases
[description not available]		05.0131
Mycoses
Diseases caused by FUNGI.		05.0131
Adrenal Cancer
[description not available]		02.0510
Hepatocellular Carcinoma
[description not available]		02.0510
Cancer of Liver
[description not available]		02.0510
Carcinoma, Hepatocellular
A primary malignant neoplasm of epithelial liver cells. It ranges from a well-differentiated tumor with EPITHELIAL CELLS indistinguishable from normal HEPATOCYTES to a poorly differentiated neoplasm. The cells may be uniform or markedly pleomorphic, or form GIANT CELLS. Several classification schemes have been suggested.		02.0510
Liver Neoplasms
Tumors or cancer of the LIVER.		02.0510
Allergy, Drug
[description not available]		03.5280
Delayed Hypersensitivity
[description not available]		02.730
Drug Hypersensitivity
Immunologically mediated adverse reactions to medicinal substances used legally or illegally.		03.5280
Community Acquired Infection
[description not available]		03.8221
Airflow Obstruction, Chronic
[description not available]		02.420
Opportunistic Infections
An infection caused by an organism which becomes pathogenic under certain conditions, e.g., during immunosuppression.		05.9652
Pulmonary Disease, Chronic Obstructive
A disease of chronic diffuse irreversible airflow obstruction. Subcategories of COPD include CHRONIC BRONCHITIS and PULMONARY EMPHYSEMA.		02.420
Recrudescence
[description not available]		03.4411
Anaplasma Infection
[description not available]		02.0510
Primary Peritonitis
[description not available]		010.192212
Peritonitis
INFLAMMATION of the PERITONEUM lining the ABDOMINAL CAVITY as the result of infectious, autoimmune, or chemical processes. Primary peritonitis is due to infection of the PERITONEAL CAVITY via hematogenous or lymphatic spread and without intra-abdominal source. Secondary peritonitis arises from the ABDOMINAL CAVITY itself through RUPTURE or ABSCESS of intra-abdominal organs.		010.192212
Infections, Respiratory
[description not available]		07.09147
Respiratory Tract Infections
Invasion of the host RESPIRATORY SYSTEM by microorganisms, usually leading to pathological processes or diseases.		07.09147
Infection, Wound
[description not available]		04.0731
Ischemia
A hypoperfusion of the BLOOD through an organ or tissue caused by a PATHOLOGIC CONSTRICTION or obstruction of its BLOOD VESSELS, or an absence of BLOOD CIRCULATION.		02.0610
Acid Aspiration Syndrome
[description not available]		04.3622
Pneumonia, Aspiration
A type of lung inflammation resulting from the aspiration of food, liquid, or gastric contents into the upper RESPIRATORY TRACT.		04.3622
Choledocholithiasis
Presence or formation of GALLSTONES in the COMMON BILE DUCT.		02.0710
Pneumothorax, Primary Spontaneous
[description not available]		02.0710
Granulomatosis, Wegener's
[description not available]		02.0710
Pneumothorax
An accumulation of air or gas in the PLEURAL CAVITY, which may occur spontaneously or as a result of trauma or a pathological process. The gas may also be introduced deliberately during PNEUMOTHORAX, ARTIFICIAL.		02.0710
Granulomatosis with Polyangiitis
A multisystemic disease of a complex genetic background. It is characterized by inflammation of the blood vessels (VASCULITIS) leading to damage in any number of organs. The common features include granulomatous inflammation of the RESPIRATORY TRACT and KIDNEYS. Most patients have measurable autoantibodies (ANTINEUTROPHIL CYTOPLASMIC ANTIBODIES) against MYELOBLASTIN.		02.0710
Bone Diseases
Diseases of BONES.		03.7721
Abscess, Pulmonary
[description not available]		02.0110
Arthritis, Post-Infectious
[description not available]		02.0110
Lung Abscess
Solitary or multiple collections of PUS within the lung parenchyma as a result of infection by bacteria, protozoa, or other agents.		02.0110
Arthritis, Reactive
An aseptic, inflammatory arthritis developing secondary to a primary extra-articular infection, most typically of the GASTROINTESTINAL TRACT or UROGENITAL SYSTEM. The initiating trigger pathogens are usually SHIGELLA; SALMONELLA; YERSINIA; CAMPYLOBACTER; or CHLAMYDIA TRACHOMATIS. Reactive arthritis is strongly associated with HLA-B27 ANTIGEN.		02.0110
Pus
[description not available]		04.8542
Cellulitis, Pelvic
[description not available]		03.3911
Parametritis
Inflammation of the parametrium, the connective tissue of the pelvic floor, extending from the subserous coat of the uterus laterally between the layers of the BROAD LIGAMENT.		03.3911
Diffuse Parenchymal Lung Disease
[description not available]		02.0110
Bleb
[description not available]		02.0110
Centriacinar Emphysema
[description not available]		02.0110
Lung Diseases, Interstitial
A diverse group of lung diseases that affect the lung parenchyma. They are characterized by an initial inflammation of PULMONARY ALVEOLI that extends to the interstitium and beyond leading to diffuse PULMONARY FIBROSIS. Interstitial lung diseases are classified by their etiology (known or unknown causes), and radiological-pathological features.		02.0110
Pulmonary Consumption
[description not available]		03.1250
Tuberculosis, Pulmonary
MYCOBACTERIUM infections of the lung.		03.1250
Bacteroides Infections
Infections with bacteria of the genus BACTEROIDES.		02.3920
Leucocythaemia
[description not available]		05.6773
Leukemia
A progressive, malignant disease of the blood-forming organs, characterized by distorted proliferation and development of leukocytes and their precursors in the blood and bone marrow. Leukemias were originally termed acute or chronic based on life expectancy but now are classified according to cellular maturity. Acute leukemias consist of predominately immature cells; chronic leukemias are composed of more mature cells. (From The Merck Manual, 2006)		05.6773
Brain Abscess
A circumscribed collection of purulent exudate in the brain, due to bacterial and other infections. The majority are caused by spread of infected material from a focus of suppuration elsewhere in the body, notably the PARANASAL SINUSES, middle ear (see EAR, MIDDLE); HEART (see also ENDOCARDITIS, BACTERIAL), and LUNG. Penetrating CRANIOCEREBRAL TRAUMA and NEUROSURGICAL PROCEDURES may also be associated with this condition. Clinical manifestations include HEADACHE; SEIZURES; focal neurologic deficits; and alterations of consciousness. (Adams et al., Principles of Neurology, 6th ed, pp712-6)		02.4220
Middle Ear Inflammation
[description not available]		02.0210
Otitis Media
Inflammation of the MIDDLE EAR including the AUDITORY OSSICLES and the EUSTACHIAN TUBE.		02.0210
Carcinoma, Oat Cell
[description not available]		04.0831
Cancer of Lung
[description not available]		05.1962
Lung Neoplasms
Tumors or cancer of the LUNG.		05.1962
Carcinoma, Small Cell
An anaplastic, highly malignant, and usually bronchogenic carcinoma composed of small ovoid cells with scanty neoplasm. It is characterized by a dominant, deeply basophilic nucleus, and absent or indistinct nucleoli. (From Stedman, 25th ed; Holland et al., Cancer Medicine, 3d ed, p1286-7)		04.0831
Acquired Autoimmune Hemolytic Anemia
[description not available]		02.0210
Anemia, Hemolytic, Autoimmune
Acquired hemolytic anemia due to the presence of AUTOANTIBODIES which agglutinate or lyse the patient's own RED BLOOD CELLS.		02.0210
Antibiotic-Associated Colitis
[description not available]		02.0210
Enterocolitis, Pseudomembranous
An acute inflammation of the INTESTINAL MUCOSA that is characterized by the presence of pseudomembranes or plaques in the SMALL INTESTINE (pseudomembranous enteritis) and the LARGE INTESTINE (pseudomembranous colitis). It is commonly associated with antibiotic therapy and CLOSTRIDIUM DIFFICILE colonization.		02.0210
Fasciitis, Necrotizing
A fulminating bacterial infection of the deep layers of the skin and FASCIA. It can be caused by many different organisms, with STREPTOCOCCUS PYOGENES being the most common.		02.0210
Diabetes Mellitus, Adult-Onset
[description not available]		02.0210
Diabetic Glomerulosclerosis
[description not available]		02.0210
Diabetes Mellitus, Type 2
A subclass of DIABETES MELLITUS that is not INSULIN-responsive or dependent (NIDDM). It is characterized initially by INSULIN RESISTANCE and HYPERINSULINEMIA; and eventually by GLUCOSE INTOLERANCE; HYPERGLYCEMIA; and overt diabetes. Type II diabetes mellitus is no longer considered a disease exclusively found in adults. Patients seldom develop KETOSIS but often exhibit OBESITY.		02.0210
Diabetic Nephropathies
KIDNEY injuries associated with diabetes mellitus and affecting KIDNEY GLOMERULUS; ARTERIOLES; KIDNEY TUBULES; and the interstitium. Clinical signs include persistent PROTEINURIA, from microalbuminuria progressing to ALBUMINURIA of greater than 300 mg/24 h, leading to reduced GLOMERULAR FILTRATION RATE and END-STAGE RENAL DISEASE.		02.0210
Purpura, Thrombopenic
[description not available]		02.0310
Purpura, Thrombocytopenic
Any form of purpura in which the PLATELET COUNT is decreased. Many forms are thought to be caused by immunological mechanisms.		02.0310
Intestinal Diseases
Pathological processes in any segment of the INTESTINE from DUODENUM to RECTUM.		03.4111
Agranulocytosis
A decrease in the number of GRANULOCYTES; (BASOPHILS; EOSINOPHILS; and NEUTROPHILS).		06.0584
Bacterial Skin Diseases
[description not available]		0533
Skin Diseases, Bacterial
Skin diseases caused by bacteria.		0533
Perforated Appendicitis
[description not available]		08.7898
Empyema, Gall Bladder
[description not available]		07.8355
Intestinal Perforation
Opening or penetration through the wall of the INTESTINES.		08.486
Peptic Ulcer Perforation
Penetration of a PEPTIC ULCER through the wall of DUODENUM or STOMACH allowing the leakage of luminal contents into the PERITONEAL CAVITY.		07.4544
Appendicitis
Acute inflammation of the APPENDIX. Acute appendicitis is classified as simple, gangrenous, or perforated.		08.7898
Cholecystitis
Inflammation of the GALLBLADDER; generally caused by impairment of BILE flow, GALLSTONES in the BILIARY TRACT, infections, or other diseases.		07.8355
Diverticulitis
Inflammation of a DIVERTICULUM or diverticula.		07.4544
Urinary Tract Diseases
[description not available]		01.9710
Puerperal Disorders
Disorders or diseases associated with PUERPERIUM, the six-to-eight-week period immediately after PARTURITION in humans.		01.9710
Benign Neoplasms
[description not available]		05.1762
Neoplasms
New abnormal growth of tissue. Malignant neoplasms show a greater degree of anaplasia and have the properties of invasion and metastasis, compared to benign neoplasms.		05.1762
Endotoxemia
A condition characterized by the presence of ENDOTOXINS in the blood. On lysis, the outer cell wall of gram-negative bacteria enters the systemic circulation and initiates a pathophysiologic cascade of pro-inflammatory mediators.		03.4111
Acute Respiratory Distress Syndrome
[description not available]		02.4220
Respiratory Distress Syndrome
A syndrome characterized by progressive life-threatening RESPIRATORY INSUFFICIENCY in the absence of known LUNG DISEASES, usually following a systemic insult such as surgery or major TRAUMA.		02.4220
Emphysema
A pathological accumulation of air in tissues or organs.		02.420
Gastritis
Inflammation of the GASTRIC MUCOSA, a lesion observed in a number of unrelated disorders.		02.0310
Depression, Endogenous
[description not available]		02.0310
Anasarca
[description not available]		02.0310
Depressive Disorder
An affective disorder manifested by either a dysphoric mood or loss of interest or pleasure in usual activities. The mood disturbance is prominent and relatively persistent.		02.0310
Edema
Abnormal fluid accumulation in TISSUES or body cavities. Most cases of edema are present under the SKIN in SUBCUTANEOUS TISSUE.		02.0310
Complication, Postoperative
[description not available]		07156
Postoperative Complications
Pathologic processes that affect patients after a surgical procedure. They may or may not be related to the disease for which the surgery was done, and they may or may not be direct results of the surgery.		07156
Inflammatory Response Syndrome, Systemic
[description not available]		03.4211
Systemic Inflammatory Response Syndrome
A systemic inflammatory response to a variety of clinical insults, characterized by two or more of the following conditions: (1) fever		03.4211
Cholera Infantum
[description not available]		03.4211
Sinusitis, Sphenoid
[description not available]		02.0310
Carcinoma, Epidermoid
[description not available]		04.0931
Carcinoma, Squamous Cell
A carcinoma derived from stratified SQUAMOUS EPITHELIAL CELLS. It may also occur in sites where glandular or columnar epithelium is normally present. (From Stedman, 25th ed)		04.0931
Pneumonia, Pneumococcal
A febrile disease caused by STREPTOCOCCUS PNEUMONIAE.		02.4220
Blood Diseases
[description not available]		06.0584
Hematologic Diseases
Disorders of the blood and blood forming tissues.		06.0584
Fever of Unknown Origin
Fever in which the etiology cannot be ascertained.		02.8940
Rupture, Spontaneous
Tear or break of an organ, vessel or other soft part of the body, occurring in the absence of external force.		03.7721
AIDS-Related Opportunistic Infections
Opportunistic infections found in patients who test positive for human immunodeficiency virus (HIV). The most common include PNEUMOCYSTIS PNEUMONIA, Kaposi's sarcoma, cryptosporidiosis, herpes simplex, toxoplasmosis, cryptococcosis, and infections with Mycobacterium avium complex, Microsporidium, and Cytomegalovirus.		01.9810
Infectious Skin Diseases
[description not available]		05.1943
Skin Diseases, Infectious
Skin diseases caused by bacteria, fungi, parasites, or viruses.		05.1943
Ulcer
A lesion on the surface of the skin or a mucous surface, produced by the sloughing of inflammatory necrotic tissue.		03.3711
Germinoblastoma
[description not available]		05.4644
Lymphoma
A general term for various neoplastic diseases of the lymphoid tissue.		05.4644
Amnionitis
[description not available]		03.7721
Premature Rupture of Fetal Membranes
[description not available]		01.9810
Labor, Premature
[description not available]		01.9810
Chorioamnionitis
INFLAMMATION of the placental membranes (CHORION; AMNION) and connected tissues such as fetal BLOOD VESSELS and UMBILICAL CORD. It is often associated with intrauterine ascending infections during PREGNANCY.		03.7721
Fetal Membranes, Premature Rupture
Spontaneous tearing of the membranes surrounding the FETUS any time before the onset of OBSTETRIC LABOR. Preterm PROM is membrane rupture before 37 weeks of GESTATION.		01.9810
Female Genital Diseases
[description not available]		06.1143
Genital Diseases, Female
Pathological processes involving the female reproductive tract (GENITALIA, FEMALE).		06.1143
Kidney Failure
A severe irreversible decline in the ability of kidneys to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism.		01.9810
Renal Insufficiency
Conditions in which the KIDNEYS perform below the normal level in the ability to remove wastes, concentrate URINE, and maintain ELECTROLYTE BALANCE; BLOOD PRESSURE; and CALCIUM metabolism. Renal insufficiency can be classified by the degree of kidney damage (as measured by the level of PROTEINURIA) and reduction in GLOMERULAR FILTRATION RATE.		01.9810
Liver Dysfunction
[description not available]		01.9810
Liver Diseases
Pathological processes of the LIVER.		01.9810
Anti-MuSK Myasthenia Gravis
[description not available]		01.9810
Myasthenia Gravis
A disorder of neuromuscular transmission characterized by fatigable weakness of cranial and skeletal muscles with elevated titers of ACETYLCHOLINE RECEPTORS or muscle-specific receptor tyrosine kinase (MuSK) autoantibodies. Clinical manifestations may include ocular muscle weakness (fluctuating, asymmetric, external ophthalmoplegia; diplopia; ptosis; and weakness of eye closure) and extraocular fatigable weakness of facial, bulbar, respiratory, and proximal limb muscles. The disease may remain limited to the ocular muscles (ocular myasthenia). THYMOMA is commonly associated with this condition.		01.9810
Complication, Intraoperative
[description not available]		03.3711
Dermatitis Medicamentosa
[description not available]		02.3920
Palmoplantaris Pustulosis
[description not available]		01.9810
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.		01.9810
Diffuse Mixed Small and Large Cell Lymphoma
[description not available]		02.3820
Lymphoma, Non-Hodgkin
Any of a group of malignant tumors of lymphoid tissue that differ from HODGKIN DISEASE, being more heterogeneous with respect to malignant cell lineage, clinical course, prognosis, and therapy. The only common feature among these tumors is the absence of giant REED-STERNBERG CELLS, a characteristic of Hodgkin's disease.		02.3820
Peritoneal Diseases
Pathological processes involving the PERITONEUM.		03.3711
Chronic Kidney Failure
[description not available]		04.2841
Kidney Failure, Chronic
The end-stage of CHRONIC RENAL INSUFFICIENCY. It is characterized by the severe irreversible kidney damage (as measured by the level of PROTEINURIA) and the reduction in GLOMERULAR FILTRATION RATE to less than 15 ml per min (Kidney Foundation: Kidney Disease Outcome Quality Initiative, 2002). These patients generally require HEMODIALYSIS or KIDNEY TRANSPLANTATION.		04.2841
Bacterial Meningitides
[description not available]		04.720
Meningitis, Bacterial
Bacterial infections of the leptomeninges and subarachnoid space, frequently involving the cerebral cortex, cranial nerves, cerebral blood vessels, spinal cord, and nerve roots.		04.720
Osteomyelitis
INFLAMMATION of the bone as a result of infection. It may be caused by a variety of infectious agents, especially pyogenic (PUS - producing) BACTERIA.		04.6232
Experimental Pneumococcal Meningitis
[description not available]		02.3820
Meningitis, Pneumococcal
An acute purulent infection of the meninges and subarachnoid space caused by Streptococcus pneumoniae, most prevalent in children and adults over the age of 60. This illness may be associated with OTITIS MEDIA; MASTOIDITIS; SINUSITIS; RESPIRATORY TRACT INFECTIONS; sickle cell disease (ANEMIA, SICKLE CELL); skull fractures; and other disorders. Clinical manifestations include FEVER; HEADACHE; neck stiffness; and somnolence followed by SEIZURES; focal neurologic deficits (notably DEAFNESS); and COMA. (From Miller et al., Merritt's Textbook of Neurology, 9th ed, p111)		02.3820
Adenocarcinoma, Basal Cell
[description not available]		03.7921
Adenocarcinoma
A malignant epithelial tumor with a glandular organization.		03.7921
Carcinoma, Large Cell
A tumor of undifferentiated (anaplastic) cells of large size. It is usually bronchogenic. (From Dorland, 27th ed)		03.3811
Allergic Cutaneous Angiitis
[description not available]		01.9910
Hallux Abductovalgus
[description not available]		01.9910
Hallux Valgus
Lateral displacement of the great toe (HALLUX), producing deformity of the first METATARSOPHALANGEAL JOINT with callous, bursa, or BUNION formation over the bony prominence.		01.9910
Staphylococcal Pneumonia
[description not available]		03.3811
Pneumonia, Staphylococcal
Pneumonia caused by infections with bacteria of the genus STAPHYLOCOCCUS, usually with STAPHYLOCOCCUS AUREUS.		03.3811
Group A Strep Infection
[description not available]		01.9910
Streptococcal Infections
Infections with bacteria of the genus STREPTOCOCCUS.		01.9910
Dementia Praecox
[description not available]		01.9910
Schizophrenia
A severe emotional disorder of psychotic depth characteristically marked by a retreat from reality with delusion formation, HALLUCINATIONS, emotional disharmony, and regressive behavior.		01.9910
Acute Hypercapnic Respiratory Failure
[description not available]		02.3820
Bronchial Cyst
[description not available]		01.9910
Respiratory Insufficiency
Failure to adequately provide oxygen to cells of the body and to remove excess carbon dioxide from them. (Stedman, 25th ed)		02.3820
Infections, Proteus
[description not available]		01.9910
Gangrene
Death and putrefaction of tissue usually due to a loss of blood supply.		04.3422
Body Weight
The mass or quantity of heaviness of an individual. It is expressed by units of pounds or kilograms.		03.7721
Weight Gain
Increase in BODY WEIGHT over existing weight.		0210
Cirrhosis
[description not available]		0210
Cecal Diseases
Pathological developments in the CECUM.		0210
Fibrosis
Any pathological condition where fibrous connective tissue invades any organ, usually as a consequence of inflammation or other injury.		0210
Bacterial Infections, Gram-Positive
[description not available]		03.3811
Gram-Positive Bacterial Infections
Infections caused by bacteria that retain the crystal violet stain (positive) when treated by the gram-staining method.		03.3811
Ureteral Calculi
Stones in the URETER that are formed in the KIDNEY. They are rarely more than 5 mm in diameter for larger renal stones cannot enter ureters. They are often lodged at the ureteral narrowing and can cause excruciating renal colic.		0210
Carcinoma, Non-Small Cell Lung
[description not available]		0210
Carcinoma, Non-Small-Cell Lung
A heterogeneous aggregate of at least three distinct histological types of lung cancer, including SQUAMOUS CELL CARCINOMA; ADENOCARCINOMA; and LARGE CELL CARCINOMA. They are dealt with collectively because of their shared treatment strategy.		0210
Rheumatoid Arthritis
[description not available]		02.0110
Arthritis, Rheumatoid
A chronic systemic disease, primarily of the joints, marked by inflammatory changes in the synovial membranes and articular structures, widespread fibrinoid degeneration of the collagen fibers in mesenchymal tissues, and by atrophy and rarefaction of bony structures. Etiology is unknown, but autoimmune mechanisms have been implicated.		02.0110
Tracheitis
INFLAMMATION of the TRACHEA that is usually associated with RESPIRATORY TRACT INFECTIONS.		02.0110
Bronchitis
Inflammation of the large airways in the lung including any part of the BRONCHI, from the PRIMARY BRONCHI to the TERTIARY BRONCHI.		02.0110
Hiccough
[description not available]		01.9810
Segond Fracture
[description not available]		01.9810
Tibial Fractures
Fractures of the TIBIA.		01.9810
P carinii Infection
[description not available]		03.3611
Pneumocystis Infections
Infections with species in the genus PNEUMOCYSTIS, a fungus causing interstitial plasma cell pneumonia (PNEUMONIA, PNEUMOCYSTIS) and other infections in humans and other MAMMALS. Immunocompromised patients, especially those with AIDS, are particularly susceptible to these infections. Extrapulmonary sites are rare but seen occasionally.		03.3611
Pleuropericarditis
Inflammation of both the PERICARDIUM and the PLEURA.		01.9710
Infections, Pneumococcal
[description not available]		01.9710
Cardiac Tamponade
Compression of the heart by accumulated fluid (PERICARDIAL EFFUSION) or blood (HEMOPERICARDIUM) in the PERICARDIUM surrounding the heart. The affected cardiac functions and CARDIAC OUTPUT can range from minimal to total hemodynamic collapse.		01.9710
Pericarditis
Inflammation of the PERICARDIUM from various origins, such as infection, neoplasm, autoimmune process, injuries, or drug-induced. Pericarditis usually leads to PERICARDIAL EFFUSION, or CONSTRICTIVE PERICARDITIS.		01.9710
Pneumococcal Infections
Infections with bacteria of the species STREPTOCOCCUS PNEUMONIAE.		01.9710
Endometrial Diseases
[description not available]		02.3820
Uterine Diseases
Pathological processes involving any part of the UTERUS.		02.3820
Adnexitis
Inflammation of the uterine appendages (ADNEXA UTERI) including infection of the FALLOPIAN TUBES (SALPINGITIS), the ovaries (OOPHORITIS), or the supporting ligaments (PARAMETRITIS).		04.3322
Endomyometritis
Inflammation of both the ENDOMETRIUM and the MYOMETRIUM, usually caused by infections after a CESAREAN SECTION.		03.7621
Pelvic Inflammatory Disease
A spectrum of inflammation involving the female upper genital tract and the supporting tissues. It is usually caused by an ascending infection of organisms from the endocervix. Infection may be confined to the uterus (ENDOMETRITIS), the FALLOPIAN TUBES; (SALPINGITIS); the ovaries (OOPHORITIS), the supporting ligaments (PARAMETRITIS), or may involve several of the above uterine appendages. Such inflammation can lead to functional impairment and infertility.		04.3322
Endometritis
Inflammation of the ENDOMETRIUM, usually caused by intrauterine infections. Endometritis is the most common cause of postpartum fever.		03.7621
Myeloproliferative Disorders
Conditions which cause proliferation of hemopoietically active tissue or of tissue which has embryonic hemopoietic potential. They all involve dysregulation of multipotent MYELOID PROGENITOR CELLS, most often caused by a mutation in the JAK2 PROTEIN TYROSINE KINASE.		03.3611
Francisella tularensis Infection
[description not available]		01.9710
Tularemia
A plague-like disease of rodents, transmissible to man. It is caused by FRANCISELLA TULARENSIS and is characterized by fever, chills, headache, backache, and weakness.		01.9710
Central Nervous System Disease
[description not available]		03.7621
Central Nervous System Diseases
Diseases of any component of the brain (including the cerebral hemispheres, diencephalon, brain stem, and cerebellum) or the spinal cord.		03.7621
Central Nervous System Origin Vertigo
[description not available]		01.9710
Vertigo
An illusion of movement, either of the external world revolving around the individual or of the individual revolving in space. Vertigo may be associated with disorders of the inner ear (EAR, INNER); VESTIBULAR NERVE; BRAINSTEM; or CEREBRAL CORTEX. Lesions in the TEMPORAL LOBE and PARIETAL LOBE may be associated with FOCAL SEIZURES that may feature vertigo as an ictal manifestation. (From Adams et al., Principles of Neurology, 6th ed, pp300-1)		01.9710
Pachymeningitis
[description not available]		03.3611
Meningitis, Meningococcal, Serogroup A
[description not available]		03.3611
Haemophilus influenzae Meningitis Type B
[description not available]		03.3611
Meningitis
Inflammation of the coverings of the brain and/or spinal cord, which consist of the PIA MATER; ARACHNOID; and DURA MATER. Infections (viral, bacterial, and fungal) are the most common causes of this condition, but subarachnoid hemorrhage (HEMORRHAGES, SUBARACHNOID), chemical irritation (chemical MENINGITIS), granulomatous conditions, neoplastic conditions (CARCINOMATOUS MENINGITIS), and other inflammatory conditions may produce this syndrome. (From Joynt, Clinical Neurology, 1994, Ch24, p6)		03.3611
Meningitis, Meningococcal
A fulminant infection of the meninges and subarachnoid fluid by the bacterium NEISSERIA MENINGITIDIS, producing diffuse inflammation and peri-meningeal venous thromboses. Clinical manifestations include FEVER, nuchal rigidity, SEIZURES, severe HEADACHE, petechial rash, stupor, focal neurologic deficits, HYDROCEPHALUS, and COMA. The organism is usually transmitted via nasopharyngeal secretions and is a leading cause of meningitis in children and young adults. Organisms from Neisseria meningitidis serogroups A, B, C, Y, and W-135 have been reported to cause meningitis. (From Adams et al., Principles of Neurology, 6th ed, pp689-701; Curr Opin Pediatr 1998 Feb;10(1):13-8)		03.3611
Cancer of Stomach
[description not available]		02.3820
Stomach Neoplasms
Tumors or cancer of the STOMACH.		02.3820
Muscle Disorders
[description not available]		01.9710
Muscular Diseases
Acquired, familial, and congenital disorders of SKELETAL MUSCLE and SMOOTH MUSCLE.		01.9710
Cancer of Skin
[description not available]		01.9710
Neuroblastoma
A common neoplasm of early childhood arising from neural crest cells in the sympathetic nervous system, and characterized by diverse clinical behavior, ranging from spontaneous remission to rapid metastatic progression and death. This tumor is the most common intraabdominal malignancy of childhood, but it may also arise from thorax, neck, or rarely occur in the central nervous system. Histologic features include uniform round cells with hyperchromatic nuclei arranged in nests and separated by fibrovascular septa. Neuroblastomas may be associated with the opsoclonus-myoclonus syndrome. (From DeVita et al., Cancer: Principles and Practice of Oncology, 5th ed, pp2099-2101; Curr Opin Oncol 1998 Jan;10(1):43-51)		01.9710
Skin Neoplasms
Tumors or cancer of the SKIN.		01.9710
Acquired Immune Deficiency Syndrome
[description not available]		03.3611
ARC
[description not available]		03.3611
Acquired Immunodeficiency Syndrome
An acquired defect of cellular immunity associated with infection by the human immunodeficiency virus (HIV), a CD4-positive T-lymphocyte count under 200 cells/microliter or less than 14% of total lymphocytes, and increased susceptibility to opportunistic infections and malignant neoplasms. Clinical manifestations also include emaciation (wasting) and dementia. These elements reflect criteria for AIDS as defined by the CDC in 1993.		03.3611
AIDS-Related Complex
A prodromal phase of infection with the human immunodeficiency virus (HIV). Laboratory criteria separating AIDS-related complex (ARC) from AIDS include elevated or hyperactive B-cell humoral immune responses, compared to depressed or normal antibody reactivity in AIDS; follicular or mixed hyperplasia in ARC lymph nodes, leading to lymphocyte degeneration and depletion more typical of AIDS; evolving succession of histopathological lesions such as localization of Kaposi's sarcoma, signaling the transition to the full-blown AIDS.		03.3611
Adenoma, Prostatic
[description not available]		01.9610
Prostatic Hyperplasia
Increase in constituent cells in the PROSTATE, leading to enlargement of the organ (hypertrophy) and adverse impact on the lower urinary tract function. This can be caused by increased rate of cell proliferation, reduced rate of cell death, or both.		01.9610
Infant, Premature, Diseases
Diseases that occur in PREMATURE INFANTS.		03.3611
Acute Myelogenous Leukemia
[description not available]		03.3611
Leukemia, Myeloid, Acute
Clonal expansion of myeloid blasts in bone marrow, blood, and other tissue. Myeloid leukemias develop from changes in cells that normally produce NEUTROPHILS; BASOPHILS; EOSINOPHILS; and MONOCYTES.		03.3611
Dermatoses
[description not available]		01.9710
Skin Diseases
Diseases involving the DERMIS or EPIDERMIS.		01.9710
Atresia, Biliary
[description not available]		01.9710
Biliary Atresia
Progressive destruction or the absence of all or part of the extrahepatic BILE DUCTS, resulting in the complete obstruction of BILE flow. Usually, biliary atresia is found in infants and accounts for one third of the neonatal cholestatic JAUNDICE.		01.9710
Action Tremor
[description not available]		01.9710
Tremor
Cyclical movement of a body part that can represent either a physiologic process or a manifestation of disease. Intention or action tremor, a common manifestation of CEREBELLAR DISEASES, is aggravated by movement. In contrast, resting tremor is maximal when there is no attempt at voluntary movement, and occurs as a relatively frequent manifestation of PARKINSON DISEASE.		01.9710
Foot Diseases
Anatomical and functional disorders affecting the foot.		03.2920
Bronchial Pneumonia
[description not available]		01.9710
Obstructive Lung Diseases
[description not available]		01.9710
Lung Diseases, Obstructive
Any disorder marked by obstruction of conducting airways of the lung. AIRWAY OBSTRUCTION may be acute, chronic, intermittent, or persistent.		01.9710
Heart Valve Diseases
Pathological conditions involving any of the various HEART VALVES and the associated structures (PAPILLARY MUSCLES and CHORDAE TENDINEAE).		01.9710
Infections, Chlamydia
[description not available]		01.9710
Neisseria gonorrhoeae Infection
[description not available]		01.9710
Chlamydia Infections
Infections with bacteria of the genus CHLAMYDIA.		01.9710
Gonorrhea
Acute infectious disease characterized by primary invasion of the urogenital tract. The etiologic agent, NEISSERIA GONORRHOEAE, was isolated by Neisser in 1879.		01.9710
Arthritides, Bacterial
[description not available]		03.3511