RecruitingPhase 3NCT07089186

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

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

Sponsor

Qilu Pharmaceutical Co., Ltd.

Enrollment

80 participants

Start Date

Apr 12, 2025

Study Type

INTERVENTIONAL

Conditions

Hospital-acquired Bacterial Pneumonia (HABP)Ventilator-associated Bacterial Pneumonia (VABP)Complicated Intra-abdominal Infection (cIAI)Complicated Urinary Tract Infection (cUTI)Bloodstream Infection (BSI)

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).

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) and a drug called Meropenem and Pralurbactam for people with bloodstream infection (bsi), complicated intra-abdominal infection (ciai), and other related conditions. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 80 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGMeropenem and Pralurbactam

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

DRUGBest 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

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NCT07089186

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