Evaluating the effectiveness of CAZ/AVI and FOS for treating CRE 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 multicenter international observational study focuses on adult patients with infections caused by carbapenem-resistant Enterobacterales (CRE). It aims to assess the efficacy of ceftazidime/avibactam (CAZ/AVI) alone or in combination with fosfomycin (FOS) in achieving optimal drug exposure and patient response. The study will analyze pharmacokinetics and pharmacodynamics to determine the best treatment approaches for these challenging infections. By documenting patient outcomes, the study seeks to establish a standardized approach to managing CRE infections.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Signature of the informed consent
* Age ≥ 18 years
* Adult patients treated for ≥ 48 hours with CAZ/AVI or CAZ/AVI plus FOS for a microbiologically documented CRE infection

Exclusion Criteria:

* Polymicrobial/mixed infections with exception of cases with multiple Enterobacterales susceptible to study drugs

Where it's running

• IRCCS Azienda Ospedaliero-Universitaria di Bologna
  Bologna, Bologna, Italy Recruiting
• Instituto de Biomedicina de Sevilla (IBiS), Hospital Virgen Macarena/CSIC/Universidad de Sevilla
  Seville, Seville, Spain Recruiting

Study contacts

• Principal investigator: Maddalena Giannella, MD PhD — IRCCS Azienda Ospedaliero-Universitaria di Bologna
• Study coordinator: Maddalena Giannella, MD PhD
• Email: maddalena.giannella@unibo.it
• Phone: +390512143199

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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.