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FOsfomycin for Male Urinary Tract Infection

Study acronym: FOMUTI
StatusNot Yet Recruiting
PhasePhase 3
Started2026-07
View on ClinicalTrials.gov ↗

Amendment history

2026-06-11
notable
Study Status, Contacts/Locations v3
Primary completion pushed: 2029-06 → 2029-10
Completion pushed: 2029-06 → 2029-10
Start date2026-03→2026-07
Study sites0→1
2026-02-12
minor
Study Status, Oversight v2
Primary completion date2027-09→2029-06
Completion date2028-09→2029-06
Start date2025-06→2026-03
2025-02-17
minor
Study Status, Contacts/Locations v1
Study sites32→0
2025-02-11
minor
Original filing
Male urinary tract infections (MUTI) are often less recognised compared to those in women. French clinical guidelines practices recommend the use of antibiotics called fluoroquinolones, which are highly effective in treating MUTIs. However, these antibiotics can lead to rare but serious side effects, such as tendonitis or heart rhythm disturbances. Additionally, fluoroquinolones can contribute to the development of bacterial resistance, making their use inadvisable within six months of treatment. In response to these concerns, we aim to explore a well-established alternative, fosfomycin trometamol (known by the brand name MONURIL®). This antibiotic has a strong track record in treating UTIs in women, with well-documented benefits and minimal associated risks. The primary goal of this study is to assess the effectiveness of fosfomycin trometamol in treating urinary tract infections in men, as well as to evaluate any potential treatment failures.
Trial Details
NCT Number NCT06822751
Lead Sponsor University Hospital, Rouen
Collaborators: INSERM UMR1311 DYNAMICURE, Department of General Practice, Rouen University, Health Ministry funding (ReSpiR funds)
Conditions Urinary Tract Infection, Prostatitis, Cystitis
Enrollment 138 participants
Start Date 2026-07
Primary Completion 2029-10 (estimated)
Study Completion 2029-10 (estimated)
Updated on ClinicalTrials.gov 2026-06-12