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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

Inclusion Criteria5

  • \. Male or female participants ≥18 and ≤80 years of age
  • \. have a diagnosis of HAP/VAP.
  • \. have systemic signs and respiratory signs or symptoms of HAP/VAP.
  • \. New or worsening infiltrate on chest X-ray/CT obtained within 48 hours prior to screening.
  • \. The estimated survival time is at lest 28 days.

Exclusion Criteria6

  • \. Diagnosed or suspected CAP, Atypical pneumonias, Viral pneumonia or Chemical pneumonia.
  • \. The total duration of antibiotic exposure for antibiotics whose administration begins in the 72 hours is longer than 24 hours.
  • \. Acute Physiology and Chronic Health Evaluation (APACHE) II score >30.
  • \. Allergic to any carbapenem, cephalosporin, penicillin, metronidazole disodium phosphate, other beta-lactam drugs or other beta-lactamase inhibitors and their auxiliary materials.
  • \. Those who have a history of drug abuse or drug abuse within 6 months before screening.
  • \. Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices.

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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

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NCT07327619