Cefepime/Enmetazobactam for Bacteremic Complicated Urinary Tract Infections

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.

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.

Conditions