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

NCT07089186 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2025-07-30

No results posted yet for this study

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

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.

Sponsors & Collaborators

  • Qilu Pharmaceutical Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-12
Primary Completion
2026-12-31
Completion
2027-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07089186 on ClinicalTrials.gov