A multicenter international prospective observational pharmacological study in adult patients (≥18 years) treated with ceftazidime/avibactam (CAZ/AVI) alone or with CAZ/AVI plus fosfomycin (FOS) for infection due to carbapenem-resistant Enterobacterales (CRE) (KPC and/or OXA-48).
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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
Primary outcome measure(s)
PK/PD efficacy targets for study drugs — From enrollment (treatment onset) to 48 and 72 hours after starting treatment The primary endpoint will be the attainment of the pre-defined PK/PD target of efficacy at 48 and 72 hours after starting treatment for Carbapenem-resistant Enterobacterales (CRE) infection
Trial sites (2)
Facility
City
Region
Status
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Bologna
Bologna
Recruiting
Instituto de Biomedicina de Sevilla (IBiS), Hospital Virgen Macarena/CSIC/Universidad de Sevilla
Seville
Seville
Recruiting
More IRCCS Azienda Ospedaliero-Universitaria di Bologna trials in Spain
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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