Ceftazidime-avibactam for the treatment of infections caused by carbapenem-resistant Gram-negative pathogens in Chinese patients: A phase IV, multi-center, open‑label study.

Authors

Jinyi Yuan, Huaxue Wang, Xiaoju Zhang, Fei Xie, Panpan Wang, Hua Zhu, Paurus Irani, Junchao Lu, Fanglei Liu, Yuting Mu, Haihui Huang, Yingyuan Zhang

Published in

International journal of antimicrobial agents. Pages 108030. Oct 03, 2026. Epub Oct 03, 2026.

Abstract

Ceftazidime-avibactam is approved in China for complicated intra‑abdominal infections (cIAIs), hospital-acquired/ventilator-associated pneumonia (HAP/VAP), and other infections with limited treatment options due to aerobic Gram‑negative bacteria. This post-approval phase IV study assessed the effectiveness and safety of ceftazidime-avibactam in Chinese adults with carbapenem-resistant Gram-negative bacterial infections.
In this prospective, multi-center, open-label, active-controlled study in China, patients with bloodstream infections, cIAIs, complicated urinary tract infections, and HAP/VAP were randomized to ceftazidime-avibactam or best available treatment (BAT). The primary efficacy endpoint was clinical response at the test-of-cure (TOC) visit in the microbiologically modified intention-to-treat (mMITT) analysis set. Endpoint comparisons were descriptive with nominal P-values.
Overall, 59 patients received ceftazidime-avibactam (n=30) or BAT (n=29), mostly for primary HAP/VAP (>70%, both arms). The most common baseline isolate was Klebsiella pneumoniae (ceftazidime-avibactam, 66.7% [16/24]; BAT, 84.6% [22/26]). In the mMITT set (n=27, each arm), clinical cure (95% confidence interval) at TOC was higher for ceftazidime-avibactam (59.3% [40.6-76.1]) than BAT (25.9% [12.4-44.3]). Microbiological response at TOC favored ceftazidime‑avibactam (59.3%) over BAT (25.9%). All-cause mortality at day 28 was similar for ceftazidime-avibactam (4/30 [13.3%]) and BAT (4/29 [13.8%]; intention‑to‑treat analysis set). Adverse events (AEs) in patients treated with ceftazidime‑avibactam versus BAT included: all-causality AEs, 24 (80.0%) vs. 26 (89.7%); serious AEs, 7 (23.3%) vs. 11 (37.9%); severe AEs, 6 (20.0%) vs. 11 (37.9%); and AEs leading to death, 5 (16.7%) vs. 7 (24.1%).
These results support the effectiveness and safety of ceftazidime‑avibactam in Chinese patients with carbapenem-resistant infections and limited treatment options.
NCT04882085.

PMID:
42829121
Bibliographic data and abstract were imported from PubMed on 04 Oct 2026.

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