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RECRUITING
NCT07089186
PHASE3

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

Sponsor: Qilu Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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

Interventions

DRUG

Meropenem and Pralurbactam

3g,q8h,180min infusion,Dose adjustments are available for participants with eGFR(mL/min)

DRUG

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