RecruitingPhase 3NCT07327619

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

420 participants

Start Date

Jan 22, 2026

Study Type

INTERVENTIONAL

Conditions

Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

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.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Ceftazidime-avibactam and a drug called Meropenem and Pralurbactam for people with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMeropenem and Pralurbactam

3g，q8h，120min infusion

DRUGCeftazidime-avibactam

2.5g，q8h，120min infusion

Locations(1)

Hunan University Of Medicine General Hospital

Huaihua, Hunan, China

View Full Details on ClinicalTrials.gov

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NCT07327619