Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- This is an observational study: the protocol does not assign a study treatment.
- Who it may be relevant to
- Registry conditions: Complicated Urinary Tract Infections, Antibiotic Resistance. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections: an Observational Prospective Study
Overview
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.
Detailed description
The study aims to evaluate the time to blood culture negativization in patients treated with cefepime/enmetazobactam (FEP/META), a drug recently introduced into clinical practice, compared with the best available therapy (BAT) for targeted treatment of complicated urinary tract infections with bacteremia caused by microorganisms harboring specific antibiotic resistance mechanisms (extended-spectrum beta-lactamase producers and OXA-48-type carbapenemase producers).
This is an investigator-initiated, observational, pharmacological, prospective multicenter cohort study that will enroll one hundred patients with urinary tract infection and bacteremia treated with cefepime/enmetazobactam, and an equal number treated with the best currently available antibiotic therapy.
Among the secondary objectives, the study aims to investigate clinical cure (defined as complete resolution of the signs and symptoms present at the time of screening) between the two groups, mortality at day 30 and day 90, the safety of cefepime/enmetazobactam, differences between the two groups in the trends of biological biomarkers, and differences in relapse rates between the two groups.
Primary outcome measures
- To evaluate the timing of microbiological eradication [Time frame: Within two weeks from the antibiotic therapy initiation]
Secondary outcome measures (1)
- To investigate clinical cure [Time frame: At day 3-7 after positive blood culture between two groups]
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 3 centers
- IRCCS Azienda Ospedaliero-Universitaria di Bologna — Bologna
- Azienda Ospedaliera di Rilievo Nazionale e di Alta Specializzazione (ARNAS) Garibaldi — Catania
- ASST Fatebenefratelli Sacco — Milan
Identifiers
NCT: NCT07725848 · CP-CUTI · 3438