FOsfomycin for Male Urinary Tract Infection

NCT06822751 | Not Yet Recruiting Phase 3

• 2 other identifiers: 2021/0376/HP2023-510355-36-00
• Study Type: interventional
• Target: 138
• Locations: 0 countries
• Sites: N/A

Brief 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 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

Keywords

Men; Cystitis; Urinary Tract Infection; Anti-infective agents, urinary; Fosfomycin

Outcome Measures

Primary Outcomes (1)

• 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

  14 days

Secondary Outcomes (5)

• Nosological (clinical and biological) description of non-febrile male urinary tract infections (MUTIs) managed in primary care.

  3 months

• Clinical cure rate 10 to 12 weeks after inclusion (i.e., 8 to 10 weeks after completion of fosfomycin trometamol (FT) 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.

  at 14 to 21 days and 10 to 12 weeks after inclusion.

• Establishment of a repository of uropathogens responsible for MUTIs.

  3 months

• Analysis of treatment-related adverse effects, 14 days after inclusion

  14 days after inclusion

Study Arms (1)

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.

Drug: Fosfomycun-trometamol

Interventions

Fosfomycun-trometamol DRUG

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.

fosfomycine-trometamol

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Presence of one or more criteria for severity of infection
• Severe sepsis or septic shock defined by a qSOFA score ≥ 2
• 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

Sponsors & Collaborators

• University Hospital, Rouen: lead
• INSERM UMR1311 DYNAMICURE: collaborator
• Department of General Practice, Rouen University: collaborator
• Health Ministry funding (ReSpiR funds): collaborator

MeSH Terms

Conditions

Urinary Tract Infections; Prostatitis; Cystitis; Multiple Endocrine Neoplasia Type 1

Condition Hierarchy (Ancestors)

Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Prostatic Diseases; Genital Diseases, Male; Genital Diseases; Urinary Bladder Diseases; Multiple Endocrine Neoplasia; Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Neoplasms, Multiple Primary; Neoplastic Syndromes, Hereditary; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Endocrine System Diseases

Study Officials

• Dr SOUDAIS, MD

  University Rouen Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dr SOUDAIS, MD

CONTACT

+33023577013; benjaminsoudais@univ-rouen.fr

Mylene HERVET

CONTACT

+330232888265; mylene.hervet@chu-rouen.fr

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 22, 2025
• First Posted: February 12, 2025
• Study Start: March 1, 2026
• Primary Completion (Estimated): June 1, 2029
• Study Completion (Estimated): June 1, 2029
• Last Updated: February 17, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share