FOsfomycin for Male Urinary Tract Infection (FOMUTI)

February 12, 2026 updated by: University Hospital, Rouen

Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

138

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • France
      • Blainville Crevon, France, 76610
        • Cabinet Médical Blainville Crevon
        • Contact:
        • Contact:
          • Dr GUIHARD Hugo
      • Bonsecours, France, 76240
        • Cabinet Médical Bonsecours
        • Contact:
        • Contact:
          • Dr PILONI Leonardo
      • Bosroumois, France, 27670
        • Cabinet Libéral medical Bosroumois
        • Contact:
          • Dr DIGARD Laurianne
          • Phone Number: +3302 35 87 78 78
          • Email: digard@drbr.fr
        • Contact:
          • Dr DIGARD Laurianne
      • Bosroumois, France, 27670
        • Pôle de Santé du Roumois Bosroumois
        • Contact:
          • Dr MATHIEU de VIENNE Hervé
          • Phone Number: +3302 35 87 78 78
          • Email: devienne@drbr.fr
        • Contact:
          • Dr MATHIEU de VIENNE Hervé
      • Bourneville, France, 27500
        • MSP Bourneville
        • Contact:
        • Contact:
          • Dr CARRAUD Benoit
      • Conches-en-ouche, France, 27190
        • Cabinet Médical Conches-en-ouche
        • Contact:
        • Contact:
          • Dr CHAUVIN Baptiste
      • Dieppe, France, 76200
        • Centre de Santé Intercommunal Dieppe- Maritime
        • Contact:
        • Contact:
          • Dr LEMOINE Edouard
      • Dieppe, France, 76200
        • Centre de santé intercommunal Dieppe
        • Contact:
        • Contact:
          • Dr LETROUIT Cyrielle
      • Elbeuf, France, 76500
        • Cabinet de médecine générale Elbeuf
        • Contact:
        • Contact:
          • Dr GYURKA Etienne
      • Elbeuf, France, 76500
        • Cabinet medical Rue de Verdun
        • Contact:
        • Contact:
          • Dr DERBOUZ Nabil
      • Elbeuf, France, 76500
        • Cabinet Médical Elbeuf
        • Contact:
        • Contact:
          • Dr SURLEMONT Mathieu
      • Elbeuf, France, 76500
        • Cabinet Médical Laënnec
        • Contact:
        • Contact:
          • Dr CORTES Marianne
      • Le Grand Quevilly, France, 76120
        • Maison Médicale Le Grand Quevilly
        • Contact:
        • Contact:
          • Dr SEVRIN Yveline
      • Le Havre, France, 76610
        • Cabinet Médical du Dr DESCAMPS
        • Contact:
        • Contact:
          • Dr BINZARI Elena
      • Le Havre, France, 76610
        • Cabinet Médical le Havre
        • Contact:
        • Contact:
          • Dr JACOMIN Olivia
      • Le Havre, France, 76610
        • Cabinet Médical, Le Havre
        • Contact:
        • Contact:
          • Dr FAGOT-GRIFFIN Elsa
      • Le Havre, France, 76620
        • Cabinet Libéral Le Havre
        • Contact:
        • Contact:
          • Dr RENOU Frédéric
      • Lomme, France, 59160
        • Cabinet médical Lomme
        • Contact:
        • Contact:
          • Dr LOEZ François
      • Louviers, France, 27400
        • Cabinet Médical Louviers
        • Contact:
        • Contact:
          • Dr THILLARD Paul
      • Oissel, France, 76350
      • Pont-de-l'arche, France, 27340
        • Maison de santé du Bord de l'Eure
        • Contact:
        • Contact:
          • Dr BOUDIER Julien
      • Romilly Sur Andelle, France, 27610
        • MSP de Romilly Sur Andelle
        • Contact:
        • Contact:
          • Dr HAZARD Emmanuel
      • Romilly sur Andelle, France, 27610
        • Cabinet Médical Romilly sur Andelle
        • Contact:
        • Contact:
          • Dr SIEFRIDT Charlotte
      • Saint Aubin les Elbeuf, France, 76410
        • Cabinet Médical Saint Aubin les Elbeuf
        • Contact:
        • Contact:
          • Dr SIMON Karine
      • Sotteville Les Rouen, France, 76300
        • Cabinet de médecine générale Sotteville Les Rouen
        • Contact:
      • St Ouen de Thouberville, France, 27310
        • Cabinet medical du clos des champs
        • Contact:
        • Contact:
          • Dr FAURE Yohann

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: fosfomycine-trometamol

Single-Arm The treatment studied is fosfomycin trometamol (FT): FOSFOMYCINE ARROW ADULTS 3 g, granule for drinkable solution in sachet.

FT is available in generic form. It comes in a sachet of 3 g of granules for oral solution (orange flavour).

In this study, FT will be taken to treat a non-febrile male urinary tract infection, at a dosage of 3 g per day every 2 days for 14 days, i.e. 7 doses (D0, D2, D4, D6, D8, D10, D14). Seven sachets, accompanied by a prescription specifying the dosage, will therefore be given to the patient on inclusion in the study.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaluate the efficacy of 14 days of fosfomycin trometamol (FT) treatment for non-febrile male urinary tract infections (MUTIs) in primary care
Time Frame: 14 days

The primary endpoint was defined as the absence of clinical failure up to 14 days after the end of antibiotic treatment.

Failure is defined according to SPILF recommendations as :

  • a change of antibiotic treatment to a reference treatment (see above) for urinary tract infection ;
  • and/or hospitalisation for urinary tract infection ;
  • or/and acute retention of urine ;
  • or/and a new consultation for worsening or persistence of symptoms ;
  • or/and the appearance of a fever > 38°C
14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Nosological (clinical and biological) description of non-febrile male urinary tract infections (MUTIs) managed in primary care.
Time Frame: 3 months
Improvement in functional urinary symptomatology using a Lickert scale (1. Very unsignificant, 2. Unsignificant , 3. Neither , 4. Significant , 5. Very significant) , 2-5 days 28-35 days and 3 months after the start of treatment with FT;
3 months
Clinical cure rate 10 to 12 weeks after inclusion (i.e., 8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment)
Time Frame: 8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment
cytobacteriological examination of the urine (CBEU) negative 10 to 12 weeks after the end of treatment ;
8 to 10 weeks after completion of fosfomycin trometamol (FT) treatment
Microbiological cure rate (assessed by cytobacterial examination of urine), at 14 to 21 days and 10 to 12 weeks after inclusion.
Time Frame: at 14 to 21 days and 10 to 12 weeks after inclusion.
Negative cytobacteriological examination of the urine (CBEU) (leucocyturia < 10/mm3 OR leucocyturia > 10/mm3 AND bacteriuria < 103/mm3 or bacteriuria with a different pathogen) taken 14 to 21 days after the end of antibiotic treatment
at 14 to 21 days and 10 to 12 weeks after inclusion.
Establishment of a repository of uropathogens responsible for MUTIs.
Time Frame: 3 months
Regression of urinary signs 10 to 12 weeks after the end of treatment;
3 months
Analysis of treatment-related adverse effects, 14 days after inclusion
Time Frame: 14 days after inclusion
Adverse events presented by the patient and recorded by the investigating doctor during antibiotic treatment and in the 14 days following the end of treatment.
14 days after inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Rouen

Collaborators

INSERM UMR1311 DYNAMICURE
Department of General Practice, Rouen University
Health Ministry funding (ReSpiR funds)

Investigators

  • Principal Investigator: Dr SOUDAIS, MD, University Rouen Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 1, 2026

Primary Completion (Estimated)

June 1, 2029

Study Completion (Estimated)

June 1, 2029

Study Registration Dates

First Submitted

January 22, 2025

First Submitted That Met QC Criteria

February 11, 2025

First Posted (Actual)

February 12, 2025

Study Record Updates

Last Update Posted (Actual)

February 17, 2026

Last Update Submitted That Met QC Criteria

February 12, 2026

Last Verified

February 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021/0376/HP
  • 2023-510355-36-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

no plan to share IPD for this study

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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