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

February 12, 2026 updated by: Qilu Pharmaceutical Co., Ltd.

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

420

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Hunan
      • Huaihua, Hunan, China, 418000
        • Recruiting
        • Hunan University of Medicine General Hospital
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • 1. Male or female participants ≥18 and ≤80 years of age

    2. have a diagnosis of HAP/VAP.

    3. have systemic signs and respiratory signs or symptoms of HAP/VAP.

    4. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.

    5. The estimated survival time is at lest 28 days.

Exclusion Criteria:

  • 1. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.

    2. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.

    3. Acute Physiology and Chronic Health Evaluation (APACHE) II score >30.

    4. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.

    5. Those who have a history of drug abuse or drug abuse within 6 months before screening.

    6. Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ceftazidime-avibactam
Drug: Ceftazidime-avibactam
2.5g，q8h，120min infusion
Experimental: Meropenem and Pralurbactam
Drug: Meropenem and Pralurbactam
3g，q8h，120min infusion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Proportion of Participants Who Died Due to Any Cause Description: Due to Day 14，Proportion of Participants Who Died Due to Any Cause in mITT
Time Frame: Day 14
Day 14

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Qilu Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 22, 2026

Primary Completion (Estimated)

June 1, 2028

Study Completion (Estimated)

October 1, 2028

Study Registration Dates

First Submitted

December 26, 2025

First Submitted That Met QC Criteria

December 26, 2025

First Posted (Actual)

January 8, 2026

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

September 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FL058-303

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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