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
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-hour IV infusion every 8 hours for 7-14 days. 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; [mMITT] analysis set) and all-cause mortality at TOC and Day 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 years. 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% 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 (mMITT analysis set). All-cause mortality was 5.7% (12/209; 95% CI: 3.2, 9.6) at TOC and Day 28 (cMITT analysis set). No new safety signals were…
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