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

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What is this study about?

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.

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 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 First follow-up assessment

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

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 One-month check

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

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 Study?

  • 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 Study?

  • 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)

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Cabinet libéral médical Bosroumis France
Cfjzbdk Ljglpdo Le Havre France
Cdwgaxs mwxgffl lomme France
Cvdvwga muczesh Saint Aubin Les Elbeuf France
Mxdncx di Symxf Pymmbtir (kmez Bourneville France
Cylmvcy Myxrkfw Le Havre France
Ctcgdoo myabtvm Bonsecours France
Mtyfao murpaoof Pont de l'Arche France
Cfqmdf do Skgvx Ilxfhjabdawpu Dieppe France
Cjpykvl mceptqp Conches-en-ouche France
Clrbquz mcmuiwr Louviers France
Mnilez db Ssngm Pfzmllyu Romilly Sur Andelle France
Cpsxrvs mshzibi Le Havre France
Cbztals mtfgmak Oissel France
Ctfnreg Mczwrwr Romilly Sur Andelle France
Cgnzeca Mwbpqjq Elbeuf France
Coshpaz dt mamjmhuu gstybvyl Sotteville Les Rouen France
Ckbxvlr mjwtvgx Blainville-Crevon France
Mfafuq mjifgzlh Le Grand Quevilly France
Cisbshj muoyqwh Saint Ouen De Thouberville France

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
France France
Not yet recruiting
02.09.2024

Trial locations

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.

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 ID:
2023-510355-36-00
Protocol code:
2021/0376/HP
Trial Phase:
Therapeutic confirmatory (Phase III)

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