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
| Registry | NCT07089186 |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: quadruple, treatment |
| Enrollment | 80 (Estimated) |
| Sponsor | Qilu Pharmaceutical Co., Ltd. (Industry) |
| 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 | Meropenem and Pralurbactam, Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) (Drug) |
| Dates | start 2025-04-12, primary completion 2026-12-01 (estimated), completion 2027-04-01 (estimated), first posted 2025-07-28, last updated 2025-07-30 |
| Locations | 1 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)
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).
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Meropenem and Pralurbactam | Experimental | Drug: Meropenem and Pralurbactam | Meropenem and Pralurbactam (180min infusion) |
| Best Available Therapy | Active comparator | Drug: Best Available Therapy (e.g., colistin, meropenem, tegecycline, amikacinceftezidime-avibatam) | Subjects will receive Best Available Therapy (IV antibiotics) |
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
| Facility | City | Country | Status |
|---|---|---|---|
| Huashan Hospital, Fudan Universit | Shanghai | China | Recruiting |