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FOsfomycin for Male Urinary Tract Infection

NCT06822751 · Status: NOT_YET_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 138

Last updated 2026-02-17

No results posted yet for this study

Summary

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.

Conditions

Interventions

DRUG

Fosfomycun-trometamol

Study of the efficacy and safety of Fosfomycin trometamol as a 14-day treatment using a 3 g sachet every 2 days for 14 days for the treatment of male urinary tract infections in primary care: open-label, non-randomised, multicentre, inter-regional trial.

Sponsors & Collaborators

  • INSERM UMR1311 DYNAMICURE

    collaborator UNKNOWN

  • Department of General Practice, Rouen University

    collaborator UNKNOWN

  • Health Ministry funding (ReSpiR funds)

    collaborator UNKNOWN

  • University Hospital, Rouen

    lead OTHER

Principal Investigators

  • Dr SOUDAIS, MD · University Rouen Hospital

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-31
Primary Completion
2029-06-30
Completion
2029-06-30

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Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06822751 on ClinicalTrials.gov