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

NCT07089186 — Phase 3, Recruiting, 80 participants, Qilu Pharmaceutical Co., Ltd.

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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

RegistryNCT07089186
StatusRecruiting
PhasePhase 3
Study typeInterventional; randomized, parallel, masking: quadruple, treatment
Enrollment80 (Estimated)
SponsorQilu Pharmaceutical Co., Ltd. (Industry)
ConditionsHospital-acquired Bacterial Pneumonia (HABP), Ventilator-associated Bacterial Pneumonia (VABP), Complicated Intra-abdominal Infection (cIAI), Complicated Urinary Tract Infection (cUTI), Bloodstream Infection (BSI)
InterventionsMeropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) (Drug)
Datesstart 2025-04-12, primary completion 2026-12-01 (estimated), completion 2027-04-01 (estimated), first posted 2025-07-28, last updated 2025-07-30
Locations1 site in China

Related Papers Related Patents Related Grants Related Experts
All trials for Hospital-acquired Bacterial Pneumonia (HABP) All trials for Ventilator-associated Bacterial Pneumonia (VABP) All trials of Meropenem and Pralurbactam All trials of Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)

-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).

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+Arms and interventions

ArmTypeInterventionsDescription
Meropenem and PralurbactamExperimentalDrug: Meropenem and PralurbactamMeropenem and Pralurbactam (180min infusion)
Best Available TherapyActive comparatorDrug: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam)Subjects will receive Best Available Therapy (IV antibiotics)
  • 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.

+Outcome measures

Primary outcomes

  • 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]

+Eligibility

Sex: All, ages: 18 Years to 80 Years

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

+Locations (1)

FacilityCityCountryStatus
Huashan Hospital, Fudan UniversitShanghaiChinaRecruiting