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drugset / Trial / NCT07327619

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

NCT07327619 ↗

Phase 3 Recruiting 420 enrolled Qilu Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-01-22
Primary completion
2028-06
Completion
2028-10

Drugs

EvaluationDrugModalityDoseRoute
Comparator Ceftazidime Small molecule — Other
Subject Meropenem Small molecule — Other
Subject Pralurbactam Small molecule — Other
Comparator avibactam Small molecule — Other

Indications

bacterial pneumonia