Oral Pivmecillinam with AmoxicillinClavulanic Acid Compared to Standard Antibiotics for Treating Febrile Urinary Tract Infections Caused by Resistant Bacteria

What this Trial Is About

Researchers are evaluating if the combination of pivmecillinam and clavulanic acid PAC is not less effective than ciprofloxacin, trimethoprim-sulfamethoxazole, or ertapenem for treating febrile urinary tract infections UTIs caused by extended spectrum beta-lactamase ESBL producing Enterobacterales EPE. This phase 3 clinical trial aims to provide clinical evidence on the safety and efficacy of PAC as a step down oral therapy compared to standard treatments in patients with these resistant infections. Participants will be randomly assigned to receive either the experimental PAC treatment, which includes 400 mg pivmecillinam and 875125 mg amoxicillinclavulanic acid taken three times daily, or one of the standard treatments ciprofloxacin 500 mg twice daily, trimethoprimsulfamethoxazole 800 mg160 mg twice daily, or ertapenem 1 g once daily, based on susceptibility. The treatments are given orally as step down therapy following initial intravenous antibiotics. The trial compares these treatments to assess non-inferiority in clinical cure and other outcomes. During the study, participants will be monitored for clinical cure approximately 10 days after treatment, with follow-up visits up to 28 days to assess recurrence of infection, microbiological cure, treatment tolerability, drug discontinuation rates, additional antibiotic use, hospital readmissions, serious adverse events, and mortality. Data collection includes urine and fecal cultures, patient questionnaires on treatment tolerability, and safety monitoring. The total study duration includes the treatment period and post-treatment follow-up to evaluate outcomes and safety.

Pivmecillinam With Amoxicillin/Clavulanic Acid for Step Down Oral Therapy in ESBL UTIs