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NCT Number: NCT07089186

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

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).

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Key information

Conditions

Hospital-acquired Bacterial Pneumonia (HABP) Bloodstream Infection (BSI) Complicated Intra-abdominal Infection (cIAI) Complicated Urinary Tract Infection (cUTI) Infections Inflammation Pathologic Processes Pathological Conditions, Signs and Symptoms Sepsis Systemic Inflammatory Response Syndrome Ventilator-associated Bacterial Pneumonia (VABP)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Meropenem and Pralurbactam

Drug

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

Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)

Drug

The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.

Primary outcomes

  1. Proportion of Participants With a Response of Overall Success(clinical response and microbiological response)[Complicated Urinary Tract Infection (cUTI)]

    Time frame: at Test of Cure (TOC) visit (Day 12-23)

  2. Proportion of Participants Who Died Due to Any Cause[Hospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP) and Bloodstream Infection(BSI) Subjects]

    Time frame: Day 28

  3. Proportion of Participants With a clinical response [Complicated Intra-abdominal Infection (cIAI) Subjects]

    Time frame: at Test of Cure (TOC) visit (Day 10-23

Study contacts

Contact information is provided by the study sponsor or research team.

Haihui Huang, PhD

CONTACT

[email protected]

021-52888195

Sponsors and collaborators

Lead sponsor

Qilu Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jul 28, 2025
Registry last updated
Jul 30, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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