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
- Authors
- Qin, Xinyu; Binh Giang Tran; Kim, Min Ja; Wang, Lie; Dung Anh Nguyen; Chen, Qian; Song, Jie; Laud, Peter J.; Stone, Gregory G.; Chow, Joseph W.
- Issue Date
- 5월-2017
- Publisher
- ELSEVIER SCIENCE BV
- Keywords
- Ceftazidime/avibactam; Complicated intra-abdominal infection; Phase 3; Efficacy; Safety; Asia
- Citation
- INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS, v.49, no.5, pp.579 - 588
- Indexed
- SCIE
SCOPUS
- Journal Title
- INTERNATIONAL JOURNAL OF ANTIMICROBIAL AGENTS
- Volume
- 49
- Number
- 5
- Start Page
- 579
- End Page
- 588
- URI
- https://scholar.korea.ac.kr/handle/2021.sw.korea/83530
- DOI
- 10.1016/j.ijantimicag.2017.01.010
- ISSN
- 0924-8579
- 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.
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