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.

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.