Actively Recruiting
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2026-02-17
420
Participants Needed
1
Research Sites
140 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
A Study to Evaluate the Efficacy and Safety of Meropenem and Pralurbactam in HABP/VABP
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female participants aged 18 to 80 years
- Diagnosis of hospital-acquired bacterial pneumonia (HAP) or ventilator-associated bacterial pneumonia (VAP)
- Presence of systemic and respiratory signs or symptoms of HAP/VAP
- New or worsening infiltrate on chest X-ray or CT within 48 hours before screening
- Estimated survival time of at least 28 days
You will not qualify if you...
- Diagnosis or suspicion of community-acquired pneumonia, atypical pneumonia, viral pneumonia, or chemical pneumonia
- Antibiotic treatment started within 72 hours before screening lasting more than 24 hours
- Acute Physiology and Chronic Health Evaluation (APACHE) II score greater than 30
- Allergy to carbapenems, cephalosporins, penicillin, metronidazole disodium phosphate, beta-lactam drugs, beta-lactamase inhibitors, or their components
- History of drug abuse or drug abuse within 6 months before screening
- Participation in other clinical trials or use of test drugs or medical devices within 28 days before randomization
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Hunan University Of Medicine General Hospital
Huaihua, Hunan, China, 418000
Actively Recruiting
Research Team
B
Bin Cao, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here