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Study to Assess the Efficacy and Safety of Meropenem and Pralurbactam in Carbapenem-Resistant Enterobacteriaceae Infections
Sponsor: Qilu Pharmaceutical Co., Ltd.
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).
Official title: A Phase 3, Multicenter, Randomized, Open-label, Active-controlled, Parallel-design Clinical Study to Evaluate the Efficacy and Safety of Meropenem and Pralubactam for Injection in the Treatment of Carbapenem-Resistant Enterobacteriaceae Infections
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-04-12
Completion Date
2027-04
Last Updated
2025-07-30
Healthy Volunteers
No
Conditions
Interventions
Meropenem and Pralurbactam
3g,q8h,180min infusion,Dose adjustments are available for participants with eGFR(mL/min)
Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)
The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.
Locations (1)
Huashan Hospital, Fudan Universit
Shanghai, China