Oral Pivmecillinam Compared to Standard Treatment for Adult Patients with Febrile E. coli Urinary Tract Infection

What this Trial Is About

Researchers are evaluating the effectiveness of oral pivmecillinam as a step-down treatment for adult patients with febrile urinary tract infections fUTI caused by Escherichia coli. This phase 4, randomized controlled trial compares pivmecillinam to standard antibiotic treatments following initial intravenous therapy. The study aims to see if pivmecillinam, a narrow-spectrum antibiotic, is as effective as the usual care in resolving infection symptoms and preventing bacterial growth in urine. Participants who have received 2 to 4 days of intravenous antibiotics and shown improvement will be randomly assigned to either oral pivmecillinam or standard treatment, which may include various oral or intravenous antibiotics determined by their doctor. Pivmecillinam will be taken as 400 mg tablets four times daily for 7 or 10 days depending on patient factors. The control group will receive standard care antibiotics for 7 to 14 days. Some participants will provide additional samples to study the drugs effects on gut bacteria and how it is processed in the body. During the study, participants will keep a diary to record medication use, symptoms, and side effects, and will have phone interviews 7 and 28 days after treatment ends to assess recovery. Urine samples will be collected at these times to check for bacteria. Subgroups will provide fecal samples over three months to study microbiome changes, and blood and urine samples will be taken from some on pivmecillinam to understand drug levels. The study will monitor clinical and microbiological responses as well as adverse events throughout the follow-up period, which extends up to 28 days post-treatment with some assessments continuing for three months.

Pivmecillinam as Oral Step-Down Treatment for Escherichia Coli Febrile Urinary Tract Infection Versus Standard of Care