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
Qilu Pharmaceutical Co., Ltd.
80 participants
Apr 12, 2025
INTERVENTIONAL
Conditions
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).
Eligibility
Inclusion Criteria5
- 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 Criteria5
- 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
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Interventions
3g，q8h，180min infusion，Dose adjustments are available for participants with eGFR(mL/min)
The main therapeutic agents anticipated for use, either in combination or as monotherapy, commonly include colistin, meropenem, tigecycline, amikacin, and ceftazidime-avibactam.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07089186