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

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07327619

Enrollment

420

Registered

2026-01-08

Start date

2026-01-22

Completion date

2028-10-01

Last updated

2026-02-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia

Brief 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.

Interventions

DRUGMeropenem and Pralurbactam

3g，q8h，120min infusion

DRUGCeftazidime-avibactam

2.5g，q8h，120min infusion

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

Healthy volunteers

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.

Design outcomes

Primary

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	Day 14

Countries

China

Contacts

CONTACTBin Cao, PhD

caobin_ben@163.com010 8420 6266

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 18, 2026