A randomised, double-blind, phase 3 study comparing the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem for complicated intra-abdominal infections in hospitalised adults in Asia
DC Field | Value | Language |
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dc.contributor.author | Qin, Xinyu | - |
dc.contributor.author | Binh Giang Tran | - |
dc.contributor.author | Kim, Min Ja | - |
dc.contributor.author | Wang, Lie | - |
dc.contributor.author | Dung Anh Nguyen | - |
dc.contributor.author | Chen, Qian | - |
dc.contributor.author | Song, Jie | - |
dc.contributor.author | Laud, Peter J. | - |
dc.contributor.author | Stone, Gregory G. | - |
dc.contributor.author | Chow, Joseph W. | - |
dc.date.accessioned | 2021-09-03T06:31:05Z | - |
dc.date.available | 2021-09-03T06:31:05Z | - |
dc.date.created | 2021-06-16 | - |
dc.date.issued | 2017-05 | - |
dc.identifier.issn | 0924-8579 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/83530 | - |
dc.description.abstract | Ceftazidime/avibactam comprises the broad-spectrum cephalosporin ceftazidime and the non-beta-lactam beta-lactamase inhibitor avibactam. This phase 3, randomised, double-blind study (NCT01726023) assessed the efficacy and safety of ceftazidime/avibactam plus metronidazole compared with meropenem in patients with complicated intra-abdominal infection (cIAI) in Asian countries. Subjects aged 18-90 years and hospitalised with cIAI requiring surgical intervention were randomised 1: 1 to receive every 8 h either: ceftazidime/avibactam (2000/500 mg, 2-h infusion) followed by metronidazole (500 mg, 60-min infusion); or meropenem (1000 mg, 30-min infusion). Non-inferiority of ceftazidime/avibactam plus metronidazole to meropenem was concluded if the lower limit of the 95% confidence interval (CI) for the between-group difference in clinical cure rate was greater than -12.5% at the test-of-cure (TOC) visit (28-35 days after randomisation) in the clinically evaluable (CE) population. Safety was also evaluated. Of 441 subjects randomised, 432 received at least one dose of study medication (ceftazidime/avibactam plus metronidazole, n = 215; meropenem, n = 217). In the CE population at the TOC visit, non-inferiority of ceftazidime/avibactam plus metronidazole to meropenem was demonstrated, with clinical cure reported for 93.8% (166/177) and 94.0% (173/184) of subjects, respectively (between-group difference, -0.2, 95% CI -5.53 to 4.97). The clinical cure rate with ceftazidime/avibactam plus metronidazole was comparable in subjects with ceftazidime-non-susceptible and ceftazidime-susceptible isolates (95.7% vs. 92.1%, respectively). Adverse events were similar between the study groups. Ceftazidime/avibactam plus metronidazole was non-inferior to meropenem in the treatment of cIAIs in Asian populations and was effective against ceftazidime-non-susceptible pathogens. No new safety concerns were identified. (C) 2017 The Authors. Published by Elsevier B.V. | - |
dc.language | English | - |
dc.language.iso | en | - |
dc.publisher | ELSEVIER SCIENCE BV | - |
dc.subject | URINARY-TRACT-INFECTIONS | - |
dc.subject | INCLUDING ACUTE PYELONEPHRITIS | - |
dc.subject | RESISTANCE TRENDS SMART | - |
dc.subject | AMPC BETA-LACTAMASES | - |
dc.subject | KLEBSIELLA-PNEUMONIAE | - |
dc.subject | PACIFIC REGION | - |
dc.subject | II TRIAL | - |
dc.subject | AVIBACTAM | - |
dc.subject | ENTEROBACTERIACEAE | - |
dc.subject | PHARMACOKINETICS | - |
dc.title | A randomised, double-blind, phase 3 study comparing the efficacy and safety of ceftazidime/avibactam plus metronidazole versus meropenem for complicated intra-abdominal infections in hospitalised adults in Asia | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Kim, Min Ja | - |
dc.identifier.doi | 10.1016/j.ijantimicag.2017.01.010 | - |
dc.identifier.scopusid | 2-s2.0-85017371968 | - |
dc.identifier.wosid | 000402467500010 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS, v.49, no.5, pp.579 - 588 | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS | - |
dc.citation.title | INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS | - |
dc.citation.volume | 49 | - |
dc.citation.number | 5 | - |
dc.citation.startPage | 579 | - |
dc.citation.endPage | 588 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Infectious Diseases | - |
dc.relation.journalResearchArea | Microbiology | - |
dc.relation.journalResearchArea | Pharmacology & Pharmacy | - |
dc.relation.journalWebOfScienceCategory | Infectious Diseases | - |
dc.relation.journalWebOfScienceCategory | Microbiology | - |
dc.relation.journalWebOfScienceCategory | Pharmacology & Pharmacy | - |
dc.subject.keywordPlus | URINARY-TRACT-INFECTIONS | - |
dc.subject.keywordPlus | INCLUDING ACUTE PYELONEPHRITIS | - |
dc.subject.keywordPlus | RESISTANCE TRENDS SMART | - |
dc.subject.keywordPlus | AMPC BETA-LACTAMASES | - |
dc.subject.keywordPlus | KLEBSIELLA-PNEUMONIAE | - |
dc.subject.keywordPlus | PACIFIC REGION | - |
dc.subject.keywordPlus | II TRIAL | - |
dc.subject.keywordPlus | AVIBACTAM | - |
dc.subject.keywordPlus | ENTEROBACTERIACEAE | - |
dc.subject.keywordPlus | PHARMACOKINETICS | - |
dc.subject.keywordAuthor | Ceftazidime/avibactam | - |
dc.subject.keywordAuthor | Complicated intra-abdominal infection | - |
dc.subject.keywordAuthor | Phase 3 | - |
dc.subject.keywordAuthor | Efficacy | - |
dc.subject.keywordAuthor | Safety | - |
dc.subject.keywordAuthor | Asia | - |
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