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A study of fosfomycin trometamol treatment for male urinary tract infections in primary care settings

Registered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on treating male urinary tract infections using an antibiotic called fosfomycin trometamol. This type of infection affects the urinary system and can cause symptoms such as burning during urination, frequent need to urinate, and pelvic pain. The medication comes in the form of granules that are dissolved in water and taken by mouth.

The purpose of this research is to evaluate how well fosfomycin trometamol works when given as a 14-day treatment for men with urinary tract infections who receive care from their family doctor. The medication will be given as an oral solution once daily, with each dose containing 3 grams of the active substance.

During the study, participants will be monitored for improvement in their urinary symptoms. Doctors will check if the infection clears up and watch for any side effects that may occur during the treatment period and in the two weeks after completing the medication. Follow-up visits will take place at various points during and after the treatment to assess how well the medication worked.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial consultation and eligibility check

    Your doctor will evaluate if you have symptoms of urinary tract infection, which may include urinary burning, urgency to urinate, frequent urination, difficulty urinating, blood in urine, or pelvic pain

    To participate, you must be a male aged 18 or older and have at least one of these symptoms that appeared within the last 3 months

  2. Step 2

    Treatment initiation

    You will receive Fosfomycin Trometamol treatment that will last for 14 days

    The medication comes as granules that you need to dissolve in water and take by mouth

    Your doctor will provide specific instructions about when and how to take the medication

  3. Step 3

    First follow-up assessment

    Between days 2-5 after starting treatment, your urinary symptoms will be evaluated

  4. Step 4

    Post-treatment evaluation

    14-21 days after completing treatment, you will need to provide a urine sample for laboratory testing

    The test will check for the presence of bacteria and white blood cells in your urine

  5. Step 5

    One-month check

    Between days 28-35 after starting treatment, your urinary symptoms will be evaluated again

  6. Step 6

    Final assessment

    10-12 weeks after completing treatment, you will have a final evaluation

    This includes a urine test and assessment of any remaining urinary symptoms

    Your doctor will record any side effects that occurred during the treatment period and up to 14 days after completion

Who can join the trial?

13 criteria

  • Must be a male aged 18 or older
  • Must be under the care of a general practice physician
  • Must have suspected male urinary tract infection with at least one of these recent symptoms (within the last 3 months):
    • Urinary symptoms such as:
      • Burning sensation during urination
      • Urgent need to urinate (urgency)
      • Frequent urination (pollakiuria)
      • Painful urination (dysuria)
      • Blood in urine (hematuria)
      • Pelvic pain not related to urination in areas such as:
        • Above the pubic bone (suprapubic)
        • Between the genitals and anus (perineal)
        • In the urinary tube (urethral)
        • Must be able to read and understand the study information and sign the consent form
        • Must have active social security coverage or be a beneficiary of such coverage
        • Must be able to understand and follow study requirements

Who cannot join the trial?

15 criteria

  • Age below 18 years or above 65 years
  • Female patients (study is for male patients only)
  • Known allergy or hypersensitivity to Fosfomycin Trometamol
  • Severe kidney problems (renal insufficiency)
  • Current use of antibiotics for other infections
  • Presence of fever above 38.5°C (101.3°F)
  • Having a permanent urinary catheter
  • Diagnosed prostate cancer
  • Recent urinary tract surgery (within last 3 months)
  • Immune system disorders that could affect treatment response
  • Participation in another clinical trial within the last 30 days
  • Inability to follow study procedures or attend follow-up visits
  • Severe liver disease
  • Uncontrolled diabetes
  • History of recurring urinary tract infections (more than 3 episodes in the past year)
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Investigated drugs

Fosfomycin trometamol is an antibiotic medication used to treat urinary tract infections. It works by stopping the growth of bacteria that cause the infection. This medication is particularly being studied for treating urinary tract infections in male patients in primary care settings. It's taken orally and is known for being effective against various bacteria that commonly cause urinary tract infections.

What is already known about the treatment

Fosfomycin Trometamol – An oral antibiotic medication administered in granule form that must be dissolved in water before drinking. This broad-spectrum antibiotic works by interfering with bacterial cell wall synthesis by blocking the enzyme that helps form peptidoglycan, an essential component of bacterial cell walls. It is primarily used to treat urinary tract infections and has shown particular effectiveness in treating male urinary tract infections in primary care settings. Fosfomycin Trometamol belongs to the phosphonic acid antibiotic class and is notable for its unique mechanism of action, which helps reduce the likelihood of bacterial resistance compared to other commonly used antibiotics.

Investigated diseases

Male Urinary Tract Infection - A bacterial infection affecting the urinary system in men, including the bladder, urethra, and sometimes the kidneys. The condition typically begins when bacteria enter the urinary tract through the urethra and multiply in the bladder. In men, this infection is less common than in women due to their longer urethra and the antibacterial properties of prostate fluid. The infection usually causes symptoms such as frequent urination, burning sensation during urination, cloudy or strong-smelling urine, and pressure in the lower abdomen. The condition may also cause urinary urgency and discomfort in the pelvic area.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-510355-36-00Protocol code2021/0376/HPEstimated enrolment110 patientsSponsorCentre Hospitalier Universitaire Rouen

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