Actively Recruiting
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
Led by Qilu Pharmaceutical Co., Ltd. · Updated on 2025-07-30
80
Participants Needed
1
Research Sites
102 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study will evaluate the efficacy and safety of Meropenem and Pralurbactam versus Best Available Therapy in the treatment of Carbapenem-Resistant Enterobacteriaceae Infections. Infections evaluated in the study will be hospital-acquired bacterial pneumonia (HABP), ventilator-associated bacterial pneumonia (VABP), complicated intra-abdominal infection (cIAI), complicated urinary tract infection (cUTI), and Bloodstream Infection (BSI).
CONDITIONS
Official Title
Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Hospitalized male or female aged 18 to 80 years
- Diagnosis of infection (HABP, VABP, cUTI, cIAI, or BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae requiring IV antibacterial therapy
- Prior empiric antibacterial therapy for carbapenem-resistant pathogen must meet one of: no or ≤24 hours; worsening symptoms after ≥48 hours; no symptom change after ≥72 hours
- Estimated survival time more than 28 days
- Understand and agree to study procedures and provide informed consent
You will not qualify if you...
- Need for more than 3 systemic antibiotics as part of best available treatment
- Expected to require more than 21 days of treatment
- APACHE II score greater than 30 based on recent data
- Medical or psychiatric condition increasing risk or judged inappropriate by investigator
- Participation in other clinical trials with test drugs or devices within 28 days before randomization
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Huashan Hospital, Fudan Universit
Shanghai, China
Actively Recruiting
Research Team
H
Haihui Huang, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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