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Clinical Trials in Italy / NCT07725848
Starting soon Observational

Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections

NCT07725848 · tracked via the Priya Life Science Italy tracker
Sponsor
IRCCS Azienda Ospedaliero-Universitaria di Bologna
Phase
Observational
Started
2026-10-15
Last updated
2026-07-24

Condition(s) studied

Complicated Urinary Tract InfectionsAntibiotic Resistance

Study summary

This study is designed to better understand how well a new antibiotic combination, cefepime/enmetazobactam (FEP/META), works in patients with complicated urinary tract infections that have spread to the bloodstream (bacteremia). These infections are caused by bacteria that are resistant to several commonly used antibiotics, including bacteria that produce extended-spectrum beta-lactamases (ESBLs) or OXA-48 carbapenemases.

The main goal of the study is to compare cefepime/enmetazobactam with the best currently available antibiotic treatments to see how quickly blood cultures become negative after treatment begins, which is an important sign that the infection is improving.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: * Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT * Adult population (age ≥ 18 years) * Signed informed consent form Exclusion Criteria: * Polymicrobial/mixed infections (Gram-positive bacteria or fungi together with Gram-negative microorganisms), except in cases involving multiple Gram-negative bacteria susceptible to the study drugs * Patients with negative blood cultures * Isolation of Gram-negative microorganisms not susceptible to the study drugs (e.g., KPC-producing organisms) * Patients in palliative care or with a high likelihood of death within 72 hours from the index positive blood culture * Patients treated with inappropriate therapy for more than 48 hours * Patients discharged early without follow-up blood cultures * History of significant hypersensitivity or allergic reactions to cefepime, to any of the excipients in the respective formulations, or to beta-lactamase inhibitors (e.g., tazobactam)

Primary outcome measure(s)

  • To evaluate the timing of microbiological eradication — Within two weeks from the antibiotic therapy initiation
    To evaluate the timing of microbiological eradication in patients who received cefepime/enmetazobactam (FEP/META) compared to best available therapy (BAT) for targeted treatment of bacteremic complicated urinary tract infections (cUTIs) due to ESBL/OXA48 producers Gram-negatives

Trial sites (3)

FacilityCityRegionStatus
IRCCS Azienda Ospedaliero-Universitaria di Bologna Bologna Italy
Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi Catania Italy
ASST Fatebenefratelli Sacco Milan Italy

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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 NCT07725848 on ClinicalTrials.gov ↗ ← All trials in Italy