Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIRCCS Azienda Ospedaliero-Universitaria di Bologna
About this trial
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 criteria
Qualifiers
Patients with bacteremic cUTIs caused by Gram-negative bacteria treated with FEP/META or BAT
Adult population (age ≥ 18 years)
Signed informed consent form
Disqualifiers
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
Trial design
Treatments tested in this trial
- Not listed
Trial groups
200 Participants
are grouped into 1 trial groupSponsors and collaborators
Source ClinicalTrials.gov