Meropenem plus pralurbactam versus best available antibiotics for 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

This test compares meropenem combined with pralurbactam to current best available antibiotics for adults hospitalized with serious infections caused by carbapenem‑resistant Enterobacteriaceae.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 80 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Qilu Pharmaceutical Co., Ltd. (Industry-sponsored)
• Locations: 1 site (Shanghai)
• Trial ID: NCT07089186 on ClinicalTrials.gov

What this trial studies

This Phase 3 interventional trial assigns hospitalized adults with confirmed carbapenem‑resistant Enterobacteriaceae infections to receive either IV meropenem plus pralurbactam or best available therapy. Target infections include hospital‑acquired or ventilator‑associated bacterial pneumonia, complicated intra‑abdominal infection, complicated urinary tract infection, and bloodstream infection. Eligible participants are aged 18–80, require IV antibacterial therapy, and have an estimated survival time over 28 days, with limits on prior empiric therapy. The trial will measure clinical and safety outcomes during and after treatment and is sponsored by Qilu Pharmaceutical at Huashan Hospital, Fudan University in Shanghai.

Who should consider this trial

Good fit: Adults aged 18–80 who are hospitalized with a laboratory‑confirmed carbapenem‑resistant Enterobacteriaceae infection (HABP/VABP, cIAI, cUTI, or BSI) requiring IV antibiotics and with expected survival beyond 28 days are ideal candidates.

Not a fit: Patients expected to survive less than 28 days, those who need more than three concurrent systemic antibiotics, children, people without CRE infections, or those unable to consent are unlikely to benefit from participation.

Why it matters

Potential benefit: If successful, this regimen could offer a more effective and potentially less toxic IV antibiotic option for adults with serious infections caused by carbapenem‑resistant Enterobacteriaceae.

How similar studies have performed: Other beta‑lactam/β‑lactamase inhibitor combinations such as ceftazidime‑avibactam and meropenem‑vaborbactam have shown activity against some CRE, but meropenem plus pralurbactam has been less widely tested in large Phase 3 trials.

Eligibility criteria

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

Where this trial is running

Shanghai

• Huashan Hospital, Fudan Universit — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Haihui Huang, PhD

Conditions Hospital-acquired Bacterial Pneumonia; Ventilator-associated Bacterial Pneumonia; Complicated Intra-abdominal Infection; Complicated Urinary Tract Infection; Bloodstream Infection