Effectiveness and safety of ceftazidime-avibactam in Chinese patients with hospital-acquired pneumonia, including ventilator-associated pneumonia: A Phase 4, multi-centre, open-label study

IF 3.7 3区医学 Q2 INFECTIOUS DISEASES

Journal of global antimicrobial resistance Pub Date : 2025-06-01 DOI:10.1016/j.jgar.2025.03.001

Jinyi Yuan , Haihui Huang , Fei Guo , Aimin Li , NanYan Xu , Xiaoyue Chang , Zuke Xiao , Huiqing Zeng , Hua Qiao , Liangfa Tang , Yunsong Yu , Bin Liu , Panpan Wang , Paurus Irani , Rienk Pypstra , Junchao Lu , Fanglei Liu , Yuting Mu , Yingyuan Zhang

{"title":"Effectiveness and safety of ceftazidime-avibactam in Chinese patients with hospital-acquired pneumonia, including ventilator-associated pneumonia: A Phase 4, multi-centre, open-label study","authors":"Jinyi Yuan , Haihui Huang , Fei Guo , Aimin Li , NanYan Xu , Xiaoyue Chang , Zuke Xiao , Huiqing Zeng , Hua Qiao , Liangfa Tang , Yunsong Yu , Bin Liu , Panpan Wang , Paurus Irani , Rienk Pypstra , Junchao Lu , Fanglei Liu , Yuting Mu , Yingyuan Zhang","doi":"10.1016/j.jgar.2025.03.001","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Ceftazidime-avibactam was approved in patients with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), based on the multinational Phase 3 REPROVE study. This study assessed efficacy and safety of ceftazidime-avibactam in Chinese adults with HAP/VAP.</div></div><div><h3>Methods</h3><div>This was a Phase 4, prospective, multi-centre, open-label study, conducted at 42 sites in China. Patients with HAP/VAP received ceftazidime-avibactam 2.5 g by 2-h IV infusion every 8 h for 7–14 d. Primary efficacy endpoint was clinical response at the test-of-cure (TOC) visit in the clinical modified intent-to-treat (cMITT) analysis set. Secondary endpoints included microbiological response at TOC (microbiological modified intent-to-treat analysis set) and all-cause mortality at TOC and D 28. Results were summarized descriptively.</div></div><div><h3>Results</h3><div>Of 257 screened individuals, 235 were treated with ceftazidime-avibactam (safety analysis set); 71% were male; median age was 67 y. <em>Klebsiella pneumoniae</em> (<em>n</em> = 49 [61.3%]) and <em>Pseudomonas aeruginosa</em> (<em>n</em> = 16 [20.0%]) were the most frequently isolated baseline pathogens. Clinical cure at TOC was achieved in 62.7% patients (131/209, 95% confidence interval [CI]: [56.0, 69.0]) in the cMITT analysis set. Favourable microbiological responses at TOC occurred in 51.3% (41/80, 95% CI: [40.4, 62.0]) patients (microbiological modified intent-to-treat analysis set). All-cause mortality was 5.7% (12/209; 95% CI: 3.2, 9.6) at TOC and D 28 (cMITT analysis set). No new safety signals were identified.</div></div><div><h3>Conclusions</h3><div>Ceftazidime-avibactam was effective in Chinese patients with HAP/VAP, and results were consistent with the Phase 3 REPROVE study. These findings support the use of ceftazidime-avibactam as a potential treatment option in Chinese adults with HAP/VAP.</div></div>","PeriodicalId":15936,"journal":{"name":"Journal of global antimicrobial resistance","volume":"43 ","pages":"Pages 248-255"},"PeriodicalIF":3.7000,"publicationDate":"2025-06-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Journal of global antimicrobial resistance","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S221371652500061X","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"INFECTIOUS DISEASES","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Ceftazidime-avibactam was approved in patients with hospital-acquired pneumonia (HAP), including ventilator-associated pneumonia (VAP), based on the multinational Phase 3 REPROVE study. This study assessed efficacy and safety of ceftazidime-avibactam in Chinese adults with HAP/VAP.

Methods

This was a Phase 4, prospective, multi-centre, open-label study, conducted at 42 sites in China. Patients with HAP/VAP received ceftazidime-avibactam 2.5 g by 2-h IV infusion every 8 h for 7–14 d. Primary efficacy endpoint was clinical response at the test-of-cure (TOC) visit in the clinical modified intent-to-treat (cMITT) analysis set. Secondary endpoints included microbiological response at TOC (microbiological modified intent-to-treat analysis set) and all-cause mortality at TOC and D 28. Results were summarized descriptively.

Results

Of 257 screened individuals, 235 were treated with ceftazidime-avibactam (safety analysis set); 71% were male; median age was 67 y. Klebsiella pneumoniae (n = 49 [61.3%]) and Pseudomonas aeruginosa (n = 16 [20.0%]) were the most frequently isolated baseline pathogens. Clinical cure at TOC was achieved in 62.7% patients (131/209, 95% confidence interval [CI]: [56.0, 69.0]) in the cMITT analysis set. Favourable microbiological responses at TOC occurred in 51.3% (41/80, 95% CI: [40.4, 62.0]) patients (microbiological modified intent-to-treat analysis set). All-cause mortality was 5.7% (12/209; 95% CI: 3.2, 9.6) at TOC and D 28 (cMITT analysis set). No new safety signals were identified.

Conclusions

Ceftazidime-avibactam was effective in Chinese patients with HAP/VAP, and results were consistent with the Phase 3 REPROVE study. These findings support the use of ceftazidime-avibactam as a potential treatment option in Chinese adults with HAP/VAP.

查看原文本刊更多论文

头孢他啶-阿维巴坦治疗中国医院获得性肺炎（包括呼吸机相关性肺炎）的有效性和安全性：一项多中心、开放标签的4期研究

背景：基于多国3期REPROVE研究，头孢他啶-阿维巴坦被批准用于医院获得性肺炎（HAP）患者，包括呼吸机相关性肺炎（VAP）。本研究评估头孢他啶-阿维巴坦治疗中国成人HAP/VAP的疗效和安全性。方法：这是一项前瞻性、多中心、开放标签的4期研究，在中国42个地点进行。HAP/VAP患者给予头孢他啶-阿维巴坦2.5 g，每8小时静脉滴注2小时，连续7-14天。主要疗效终点是临床修正治疗意向（cMITT）分析集中治愈试验（TOC）访问时的临床反应。次要终点包括TOC（微生物修饰的意向治疗）的微生物反应；[mMITT]分析集)和TOC和第28天的全因死亡率。对结果进行描述性总结。结果：257名筛选个体中，235名接受头孢他啶-阿维巴坦治疗（安全性分析集）；男性占71%；中位年龄为67岁。肺炎克雷伯菌（n = 49[61.3%]）和铜绿假单胞菌（n = 16[20.0%]）是最常见的基线病原菌。在cMITT分析集中，62.7%的患者在TOC达到临床治愈（131/209,95% CI:[56.0, 69.0]）。51.3% （41/80, 95% CI:[40.4, 62.0]）的患者在TOC时出现了良好的微生物反应（mMITT分析集）。全因死亡率为5.7% (12/209；95% CI: 3.2, 9.6)在TOC和第28天（cMITT分析集）。没有发现新的安全信号。结论：头孢他啶-阿维巴坦对中国HAP/VAP患者有效，结果与REPROVE 3期研究结果一致。这些发现支持使用头孢他啶-阿维巴坦作为中国成人HAP/VAP的潜在治疗选择。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

求助全文

约1分钟内获得全文求助全文

来源期刊

Journal of global antimicrobial resistance INFECTIOUS DISEASES-PHARMACOLOGY & PHARMACY

CiteScore

8.70

自引率

2.20%

发文量

285

审稿时长

34 weeks

期刊介绍： The Journal of Global Antimicrobial Resistance (JGAR) is a quarterly online journal run by an international Editorial Board that focuses on the global spread of antibiotic-resistant microbes. JGAR is a dedicated journal for all professionals working in research, health care, the environment and animal infection control, aiming to track the resistance threat worldwide and provides a single voice devoted to antimicrobial resistance (AMR). Featuring peer-reviewed and up to date research articles, reviews, short notes and hot topics JGAR covers the key topics related to antibacterial, antiviral, antifungal and antiparasitic resistance.