Cefepime-Zidebactam Versus Ceftazidime-Avibactam With or Without Colistin for Hospital-Acquired or Ventilator-Associated Bacterial Pneumonia
brief summary
This is a Phase 3, randomized, double-blind, multicenter, comparative study evaluating cefepime-zidebactam (FEP-ZID) versus ceftazidime-avibactam (CAZ-AVI) with or without colistin in the treatment of adults with hospital-acquired bacterial pneumonia (HABP) or ventilator-associated bacterial pneumonia (VABP). Trial participants will be randomized in a 1:1 ratio to receive either FEP-ZID or CAZ-AVI with or without colistin for 7 to 14 days. Colistin will be added to the CAZ-AVI regimen (or matching saline to the FEP-ZID regimen, to maintain blinding) for participants with a baseline pathogen presumed or confirmed to be CAZ-AVI-resistant. All trial participants will also receive linezolid for coverage of methicillin-resistant staphylococci for at least the first 3 days of treatment. The primary objectives are to assess 14-day all-cause mortality between treatment groups and to assess the safety and tolerability of FEP-ZID relative to CAZ-AVI with or without colistin. Secondary objectives include 28-day all-cause mortality, clinical and microbiological outcomes at End-of-Treatment (EOT) and Test-of-Cure (TOC), sustained clinical cure at Late Follow-up (LFU), superinfection and new infection rates, and pharmacokinetic (PK) characterization of FEP and ZID.
official title
A Phase 3, Randomized, Double-Blind, Multicenter, Comparative Study of Cefepime-Zidebactam Compared With Ceftazidime-avibactam With or Without Colistin in the Treatment of Hospital-Acquired Bacterial Pneumonia or Ventilator-Associated Bacterial Pneumonia.