Urinary Tract InfectionPhase 3FOMUTINCT06822751
FOsfomycin for Male Urinary Tract Infection
A Phase 3 study testing Fosfomycun-trometamol in people with Urinary Tract Infection and Prostatitis, run by University Hospital, Rouen at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, men only
- Conditions the study is for
- Urinary Tract Infection, Prostatitis, Cystitis
- What is being tested?
- Fosfomycun-trometamol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 138 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2026to Oct 2029
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 27Show fewer
- 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)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
ELBEUF
Elbeuf, 76500
Benjamin Soudais, Dr, 02.35.77.01.13, benjamin.soudais@univ-rouen.fr
Benjamin Soudais, Dr
About this study
Official title: 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.
- Conditions
- Urinary Tract Infection, Prostatitis, Cystitis
- Being tested
- Fosfomycun-trometamol
- Keywords
- Men, Cystitis, Urinary Tract Infection, Anti-infective agents, urinary, Fosfomycin
- Medical subject headings
- Urinary Tract Infections, Prostatitis, Cystitis, Multiple Endocrine Neoplasia Type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fosfomycun-trometamolDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| fosfomycine-trometamol | Experimental | 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. Receives: Drug: Fosfomycun-trometamol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the efficacy of 14 days of fosfomycin trometamol (FT) treatment for non-febrile male urinary tract infections (MUTIs) in primary care
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
Measured: 14 days
Secondary outcomes (5)
Nosological (clinical and biological) description of non-febrile male urinary tract infections (MUTIs) managed in primary care.
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;
Measured: 3 months
Clinical cure rate 10 to 12 weeks after inclusion (i.e., 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 ;
Measured: 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.
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
Measured: at 14 to 21 days and 10 to 12 weeks after inclusion.
Establishment of a repository of uropathogens responsible for MUTIs.
Regression of urinary signs 10 to 12 weeks after the end of treatment;
Measured: 3 months
Analysis of treatment-related adverse effects, 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.
Measured: 14 days after inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2025
- Study startJul 2026 (estimated)
- Primary completionOct 2029 (estimated)
- Study completionOct 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Urinary Tract InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, RouenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 138 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Rouen
- Sponsor type
- University, hospital or other
- Collaborators
- INSERM UMR1311 DYNAMICURE, Department of General Practice, Rouen University, Health Ministry funding (ReSpiR funds)
- Responsible party
- Sponsor
- Investigators
- Dr SOUDAIS, MD, Principal investigator, University Rouen Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06822751
- Sponsor's protocol ID
- 2021/0376/HP
- Other IDs
- 2023-510355-36-00, 2023
- Acronym
- FOMUTI
- Status last verified
- Jun 2026
- First submitted
- 22 Jan 2025
- Last updated
- 12 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: no plan to share IPD for this study
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Pragmatic Trial of Fosfomycin-trometamol Treatment of Male Urinary Tract Infections in Primary Care
- ClinicalTrials.gov ID
- NCT06822751
- Acronym / sponsor ID
- FOMUTI / 2021/0376/HP
- Conditions
- Urinary Tract Infection, Prostatitis, Cystitis
- Keywords
- Men, Cystitis, Urinary Tract Infection, Anti-infective agents, urinary, Fosfomycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 138 participants (estimated)
- Lead sponsor
- University Hospital, RouenUniversity, hospital or other
- Collaborators
- INSERM UMR1311 DYNAMICURE, Department of General Practice, Rouen University, Health Ministry funding (ReSpiR funds)
- Study start
- Jul 2026 (estimated)
- Primary completion
- Oct 2029 (estimated)
- Study completion
- Oct 2029 (estimated)
- First posted
- 12 Feb 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| fosfomycine-trometamol | Experimental | Drug: Fosfomycun-trometamolSingle-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
- 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.
Key exclusion criteria (27 listed)
- Presence of one or more criteria for severity of infection
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fosfomycun-trometamolStudy 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. | Drug | fosfomycine-trometamol |
Primary outcome
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
5 secondary outcomes
Nosological (clinical and biological) description of non-febrile male urinary tract infections (MUTIs) managed in primary care.
Time frame: 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
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.
Establishment of a repository of uropathogens responsible for MUTIs.
Time frame: 3 months
Analysis of treatment-related adverse effects, 14 days after inclusion
Time frame: 14 days after inclusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2026.
- Individual participant dataSharing planned: No. no plan to share IPD for this study
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr SOUDAIS, MD principal investigator
University Rouen Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Fosfomycun-trometamol in people with Urinary Tract Infection and Prostatitis, run by University Hospital, Rouen at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 27 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr SOUDAIS, MD (+33023577013, benjaminsoudais@univ-rouen.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2026.