FOsfomycin for Male Urinary Tract Infection (NCT06822751) | Clinical Trial Compass
Not Yet RecruitingPhase 3
FOsfomycin for Male Urinary Tract Infection
France138 participantsStarted 2026-07
Plain-language 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.
Who can participate
Age range
18 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Men aged 18 years or older.
* Consulting in a primary care setting.
* Suspected of having a male urinary tract infection (MUTI) by the investigating physician and presenting at least one recent acute symptom (\< 3 months) from the following:
* Lower urinary tract symptoms: dysuria, urgency, frequency, hematuria.
* Pelvic pain unrelated to urination: suprapubic, perineal, or urethral pain.
* Patient has read and understood the information letter and signed the informed consent form.
* Affiliation with a social security system or beneficiary of such a system.
* No history of illness or psychological or sensory abnormality likely to prevent the subject from fully understanding the conditions required for participation in the protocol or to prevent him/her from giving informed consent
Exclusion Criteria:
* Presence of one or more criteria for severity of infection
* Severe sepsis or septic shock defined by a qSOFA score ≥ 2
* or/and systolic BP less than 100 mmHg: non-inclusion criterion
* or/and temperature \< 36°C or \> 38°C
* or/and diagnosis of pyelonephritis (pain on lumbar percussion)
* or/and presence of abdominal guarding/contraction
* or/and presence of a bladder globe above the pubic bone: (suspected acute retention of urine)
* or/and known immunosuppression: any immunosuppressive treatment (including corticosteroid therapy \> 10 mg/d for more than 5 days), neutropenia (PNN \< 500/mL) severe malnutrition (albumin \< 30 and/or…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Evaluate the efficacy of 14 days of fosfomycin trometamol (FT) treatment for non-febrile male urinary tract infections (MUTIs) in primary care