clinical trial · NCT07327619
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Qilu Pharmaceutical Co., Ltd.·phase3·recruiting·n = 420
Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial PneumoniaMeropenem and PralurbactamCeftazidime-avibactam
brief summary
This study is to evaluate the efficacy and safety of Meropenem and Pralurbactam for Injection in Subjects with HABP/VABP. The primary objective is to demonstrate non-inferiority of Meropenem and Pralurbactam to Ceftazidime and Avibactam Sodium for Injection. This study is a randomized, double-blind, active-controlled study. The total duration of the study will be approximately 32 days including screening and follow-up.
started
Jan 22, 2026
primary completion
Jun 1, 2028
completion
Oct 1, 2028
last updated
Feb 17, 2026
official title
A Multicenter, Randomized, Double-blind, Active-Controlled, Parallel, Phase Ⅲ Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam for Injection Compared to Ceftazidime and Avibactam Sodium for Injection in Subjects With Hospital-acquired and Ventilator-associated Bacterial Pneumonia
sourced from ClinicalTrials.gov · pharmadog mirrors structured fields, not the full protocol