A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Recruiting now · Phase 3
Conditions studied: Hospital-acquired Bacterial Pneumonia and Ventilator-associated Bacterial Pneumonia
In brief
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.
Key facts
- Study ID
- NCT07327619
- Run by
- Qilu Pharmaceutical Co., Ltd.
- People needed
- 420
- Starts
- 2026-01-22
- Expected to finish
- 2028-10-01
- Last updated by the study team
- 2026-02-17
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- 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.
Where it is running
- Hunan University Of Medicine General Hospital — Huaihua, Hunan, China (enrolling)
Full record on ClinicalTrials.gov
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