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RECRUITING
NCT07327619
PHASE3

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

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

Key Details

Gender

All

Age Range

18 Years - 80 Years

Study Type

INTERVENTIONAL

Enrollment

420

Start Date

2026-01-22

Completion Date

2028-10

Last Updated

2026-02-17

Healthy Volunteers

No

Interventions

DRUG

Meropenem and Pralurbactam

3g,q8h,120min infusion

DRUG

Ceftazidime-avibactam

2.5g,q8h,120min infusion

Locations (1)

Hunan University Of Medicine General Hospital

Huaihua, Hunan, China