MedTrace Logo

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

NCT07327619 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 420

Last updated 2026-02-17

No results posted yet for this study

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

DRUG

Meropenem and Pralurbactam

3g，q8h，120min infusion

DRUG

Ceftazidime-avibactam

2.5g，q8h，120min infusion

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-22
Primary Completion
2028-06-30
Completion
2028-10-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07327619 on ClinicalTrials.gov