Meropenem plus pralurbactam versus best available antibiotics for carbapenem‑resistant Enterobacteriaceae infections

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• Huashan Hospital, Fudan Universit
  Shanghai, China Recruiting

Study contacts

• Study coordinator: Haihui Huang, PhD
• Email: Huanghaihui73@aliyun.com
• Phone: 021-52888195

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.