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

Not Applicable

Recruiting

• 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: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam); Drug: Meropenem and Pralurbactam

• Registration Number: NCT07089186
• Lead Sponsor: Qilu Pharmaceutical Co., Ltd.

Brief 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).

Detailed Description

Not available

Study Timeline

• Study Start: 2025-04-12
• Status Verified: 2025-06
• Study First Submitted: 2025-06-25
• Study First Submitted QC: 2025-07-20
• Last Update Submitted: 2025-07-27
• Study First Posted: 2025-07-28
• Last Update Posted: 2025-07-30
• Primary Completion: 2026-12
• Study Completion: 2027-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

• Hospitalized male or female≥18 and ≤80 years of age，
• Participant must have a diagnosis of an infection (HABP/VABP, cUTI, cIAI, BSI) due to confirmed Carbapenem-Resistant Enterobacteriaceae infection, requiring administration of IV antibacterial therapy
• Participant who had received appropriate prior empiric antibacterial therapy for a carbapenem-resistant pathogen must meet at least 1 of the following criteria: no or no more than 24h; worsening of objective symptoms or signs after at least 48 hours of antibacterial therapy; no change of objective symptoms or signs after at least 72 hours of antibacterial therapy
• The estimated survival time is more than 28 days
• Understand and abide by the research procedures and methods, voluntarily participate in this research, and sign an informed consent form

Exclusion Criteria

• Participants who need more than 3 systemic antibiotics as part of best available treatment (BAT)
• Participant is expected to require more than 21 days of treatment
• Acute Physiology and Chronic Health Evaluation (APACHE) II score >30 using the most recent available data
• Other medical or psychiatric condition may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.
• Those who participated in other clinical trials within 28 days before randomization and used any test drugs or medical devices

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Best Available Therapy	Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)	Subjects will receive Best Available Therapy (IV antibiotics)
Meropenem and Pralurbactam	Meropenem and Pralurbactam	Meropenem and Pralurbactam (180min infusion)

Primary Outcome Measures

Name	Time	Method
Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]	at Test of Cure (TOC) visit (Day 12-23)
Proportion of Participants Who Died Due to Any Cause[Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bloodstream Infection(BSI) Subjects]	Day 28
Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]	at Test of Cure (TOC) visit (Day 10-23

Trial Locations

Locations (1)

Huashan Hospital, Fudan Universit; 🇨🇳 Shanghai, China