NCT07089186View on ClinicalTrials.gov

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

PHASE3RecruitingINTERVENTIONAL
Enrollment

80

Participants

Timeline

Start Date

April 12, 2025

Primary Completion Date

December 31, 2026

Study Completion Date

April 30, 2027

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

Trial Locations (1)

Unknown

RECRUITING

Huashan Hospital, Fudan Universit, Shanghai

All Listed Sponsors
lead

Qilu Pharmaceutical Co., Ltd.

INDUSTRY