Clinical Trial

Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections

Recruiting Phase 3
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Summary
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).
Protocol Amendment History 1 amendment
This ClinicalTrials.gov record has been amended once since 2025-07-20.
Trial Details
NCT Number NCT07089186
Lead Sponsor Qilu Pharmaceutical Co., Ltd.
Conditions Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI), Bloodstream Infection (BSI)
Enrollment 80 participants
Start Date 2025-04-12
Primary Completion 2026-12 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2025-07-30