FOsfomycin for Male Urinary Tract Infection (NCT06822751) | Clinical Trial Compass
Not Yet RecruitingPhase 3
FOsfomycin for Male Urinary Tract Infection
138 participantsStarted 2026-03
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 MONURILĀ®). 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 range18 Years
SexMALE
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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 ā„ 2
* or/and systolic BP less than 100 mmHg: non-inclusion criterion
* or/and temperature \< 36Ā°C or \> 38Ā°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/orā¦
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