New study could change how Men's UTIs are treated
NCT ID NCT06822751
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests whether a common antibiotic for women's UTIs, fosfomycin-trometamol, works well for men with urinary tract infections. Current treatments can have serious side effects and increase antibiotic resistance. The trial will enroll 138 men in primary care and monitor for treatment failure up to 14 days after therapy ends.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 138 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Oct 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Male participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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 BMI \< 16), * No diagnosis of male urinary tract infection in the last 3 months, * No ongoing chronic prostatitis, * Known urinary tract abnormality: urinary tract lithiasis, vesico-ureteral reflux, prostate or urinary tract cancer, prostate adenoma treated medically or surgically, urinary tract malformation (including single kidney and urethral stricture). * Acute retention of urine and indication for surgical or interventional drainage * Hyperalgesic form * Urinary tract infection associated with care, on urinary catheter or suprapubic catheter * Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation less than 3 months old * Urinary tract surgery, cystoscopy, prostate biopsy or urinary catheterisation less than 3 months old * Severe disease or high probability of death within 3 months, * Hypersensitivity to fosfomycin trometamol or to any of the excipients (notable excipients: sucrose, dextrose (source of glucose), maltodextrin (source of glucose), orange yellow colouring S (E110)), * End-stage renal disease (creatinine clearance \<10 mL/min), * Patients with glucose and galactose malabsorption syndrome or sucrase/isomaltase deficiency (rare hereditary disease) * Antibiotic taken within 72 hours of diagnosis of male urinary tract infection, * Major cognitive impairment, * Person deprived of liberty by an administrative or judicial decision or person placed under court protection / sub- guardianship or curatorship * Any 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 the subject from giving informed consent. * Known non-adherence to treatment, * Simultaneous participation in another interventional clinical study, * Cannot be taken orally (vomiting)
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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ELBEUF
Elbeuf, 76500, France
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can an ancient herbal formula beat antibiotics for urinary infections?
- AI could outsmart bacteria: a smarter way to choose antibiotics?
- Home hospital care for infections: when does it fail?
- New tool helps women with bladder infections skip unnecessary antibiotics
- Simple urine test could revolutionize schistosomiasis detection