RecruitingNot Applicable

PK/PD Relationship of CAZ/AVI and FOS in the Treatment of Patients With Infections Due to CRE

Italy, Spain60 participantsStarted 2023-12-01

Plain-language summary

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).

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

PK/PD efficacy targets for study drugs

Timeframe: From enrollment (treatment onset) to 48 and 72 hours after starting treatment

Trial details

NCT IDNCT06717594

SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2026-04-30

Contact for this trial

Maddalena Giannella, MD PhD

+390512143199 maddalena.giannella@unibo.it

View on ClinicalTrials.gov More Gram Negative Infections trials