NCT07089186

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

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: Qilu Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

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).

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

Type	Name	Description
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.

Timeline

• Start date: 2025-04-12
• Primary completion: 2026-12-01
• Completion: 2027-04-01
• First posted: 2025-07-28
• Last updated: 2025-07-30

Locations

1 site across 1 country: China