NCT07327619

A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 420 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

Interventions

Type	Name	Description
DRUG	Meropenem and Pralurbactam	3g，q8h，120min infusion
DRUG	Ceftazidime-avibactam	2.5g，q8h，120min infusion

Timeline

• Start date: 2026-01-22
• Primary completion: 2028-06-01
• Completion: 2028-10-01
• First posted: 2026-01-08
• Last updated: 2026-02-17

Locations

1 site across 1 country: China