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NCT Number: NCT07327619

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

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.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hunan University Of Medicine General Hospital

Huaihua, Hunan, 418000, China

Location status: Recruiting

Location contact

jianliang Zhou, master

CONTACT

[email protected]

0745-2383818

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 1. 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 criteria

  • 1. 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.

Treatment and study plan

Meropenem and Pralurbactam

Drug

3g,q8h,120min infusion

Ceftazidime-avibactam

Drug

2.5g,q8h,120min infusion

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Bin Cao, PhD

CONTACT

[email protected]

010 8420 6266

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Jan 8, 2026
Registry last updated
Feb 17, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.