New study could change how Men's UTIs are treated

NCT ID NCT06822751

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Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
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Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
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The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
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Cancelled before anyone took part.

Expanded access (not trials)

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Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
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Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

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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.

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Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 138 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Jul 2026

An estimate. Start dates often move.

Expected to finish

Oct 2029

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Male participants only

Healthy volunteers

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

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

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  1. The places running it

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  2. The official record

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Contacts and locations

Locations

  • ELBEUF

    Elbeuf, 76500, France

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