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NCT07725848

Overview

NCT ID: NCT07725848
Lead Sponsor: IRCCS Azienda Ospedaliero-Universitaria di BolognaOTHER
Official Title: Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections: an Observational Prospective Study
Brief 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.
Conditions: Complicated Urinary Tract Infections

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: No
Eligibility Criteria: 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)

Central Contacts: Cecilia Maria Bonazzetti, MDContact
cecilia.bonazzetti@unibo.it+390512143595