A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP (NCT07327619) | Clinical Trial Compass
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
China420 participantsStarted 2026-01-22
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
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