A phase III, multicenter, double-blind, randomized clinical trial to evaluate the efficacy and safety of ceftolozane/tazobactam plus metronidazole versus meropenem in Chinese participants with complicated intra-abdominal infections
Yihong Sun, Jia Fan, Gang Chen, Xiaofei Chen, Xiaoling Du, Ye Wang, Hui Wang, Fang Sun, Matthew G Johnson, Mekki Bensaci, Jennifer A Huntington, Christopher J Bruno, Yihong Sun, Jia Fan, Gang Chen, Xiaofei Chen, Xiaoling Du, Ye Wang, Hui Wang, Fang Sun, Matthew G Johnson, Mekki Bensaci, Jennifer A Huntington, Christopher J Bruno
Abstract
Objectives: This study aimed to evaluate the efficacy and safety of ceftolozane/tazobactam (C/T) plus metronidazole versus meropenem plus placebo for the treatment of complicated intra-abdominal infection (cIAI) in Chinese adult participants.
Methods: In this phase III clinical trial (NCT03830333), Chinese adult participants with cIAI were randomized 1:1 to receive C/T plus metronidazole or meropenem plus placebo. The primary objective was to assess C/T plus metronidazole for noninferiority versus meropenem for clinical response rate at the test of cure (TOC; 28 ± 2 days after study start) visit in the clinically evaluable population. Secondary endpoints included clinical and microbiologic responses at the TOC and end-of-treatment (≤24 hours after last dose) visits and adverse event rates.
Results: Clinical cure at the TOC visit in the clinically evaluable population was 95.2% and 93.1% for C/T plus metronidazole and meropenem, respectively (between-treatment difference: 2.1% [95% confidence interval: -4.7%, 8.8%]); thus, noninferiority was met. Clinical responses at the TOC and end-of-treatment visits and microbiologic responses at the TOC visit were consistent with the primary efficacy endpoint. Safety was comparable between study treatment groups.
Conclusion: In Chinese adult participants with cIAI, C/T plus metronidazole was noninferior to meropenem, with comparable safety.
Keywords: Antibacterial; Ceftolozane; China; Meropenem; Tazobactam.
Conflict of interest statement
Declarations of competing interest XD, YW, and FS are employees of MSD, China. XC and HW are former employees of MSD, China. MGJ, MB, JAH, and CJB are employees of MSD. MSD, China and MSD employees may own stock and/or hold stock options in Merck & Co., Inc., Rahway, NJ, USA. YS, JF, and GC have no competing interests to declare.
Copyright © 2022 Merck Sharp & Dohme LLC., a subsidiary Merck & Co., Inc.,, The Author(s). Published by Elsevier Ltd.. All rights reserved.
Source: PubMed