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Clinical Trials in Italy / NCT06717594
Recruiting Observational

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

NCT06717594 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2023-12-01
Last updated
2026-06-12

Condition(s) studied

Gram Negative InfectionsAntimicrobial Resistance (AMR)

Study 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).

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)

FacilityCityRegionStatus
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

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Other trials for the same condition

A Study to Assess How Vaborem® is Taking up in the Body and Tolerated in Paediatric Patients With Gram Negative Infections, Including But Not Restricted to Complicated Urinary Tract Infections Recruiting
PK/PD Analysis of Ceftazidime/Avibactam or Cefiderocol With or Without Fosfomycin for the Treatment of Difficult To-treat Gram-negative Infections Recruiting
Antibiotic Duration and Outcomes in High-Risk Febrile Neutropenia Patients Recruiting
Official registry record

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.

View NCT06717594 on ClinicalTrials.gov ↗ ← All trials in Italy