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Study on Fosfomycin for Treating Acute Bacterial Prostatitis in Patients with Multidrug-Resistant E. coli

Verified siteRegistered drugNo placebo
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What is this trial about?

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

This clinical trial is focused on studying the treatment of acute bacterial prostatitis, a condition that affects the prostate gland and is caused by bacteria. Specifically, the study is looking at cases where the infection is due to multidrug-resistant Escherichia coli, a type of bacteria that is resistant to many common antibiotics. The treatment being tested in this study is an oral medication called fosfomycin, which is an antibiotic that can be taken by mouth as a solution.

The purpose of the study is to evaluate the effectiveness of fosfomycin in treating this type of prostatitis. Participants in the study will receive the medication for a period of up to three days. The study will compare the results of those taking fosfomycin with a control group who are treated with other approved therapies for infections caused by non-resistant strains of Escherichia coli.

Throughout the study, participants will be monitored to assess how well the treatment works in managing the infection. The goal is to determine if fosfomycin is a viable alternative for treating this challenging condition, especially in cases where the bacteria are resistant to other treatments. This research could provide valuable insights into new ways to manage infections that are difficult to treat with standard antibiotics.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Participation begins after meeting the criteria: being a male aged 18 or older with acute bacterial prostatitis caused by Escherichia coli, either multidrug-resistant or sensitive to most antibiotics except one family.

    A positive urine or blood culture for Escherichia coli is required.

  2. Step 2

    Initial treatment phase

    Initial treatment involves receiving 1 to 5 days of intravenous antibiotics that are effective against the bacteria in laboratory tests.

    This phase is necessary to stabilize the condition before starting the main study treatment.

  3. Step 3

    Oral treatment with fosfomycin

    After stabilization, the main treatment involves taking fosfomycin orally.

    Fosfomycin is used as an alternative therapy for treating acute bacterial prostatitis caused by multidrug-resistant Escherichia coli.

    The dosage and frequency of fosfomycin administration will be determined by the study protocol.

  4. Step 4

    Monitoring and evaluation

    Throughout the study, regular monitoring will assess the effectiveness of the treatment.

    The primary goal is to determine the success of oral fosfomycin in treating the infection.

  5. Step 5

    Completion of the study

    The study is expected to conclude by December 31, 2026.

    Final evaluations will be conducted to assess the overall outcomes and effectiveness of the treatment.

Who can join the trial?

6 criteria

  • Participants must be **men** aged **18 years or older**.
  • Participants must have **acute bacterial prostatitis**, which is an infection of the prostate gland.
  • Participants must have a **positive urine or blood culture** showing the presence of **Escherichia coli** (E. coli) bacteria.
  • For the main group, the E. coli must be **multidrug-resistant** but **sensitive to fosfomycin**, a type of antibiotic.
  • For the control group, the E. coli must be **sensitive to all or all but one family of antibiotics**.
  • Participants will be matched with others based on **sex, age, and clinical diagnosis**.

Who cannot join the trial?

3 criteria

  • Only men can participate in this study. Women are not eligible.
  • Participants must be adults, meaning they should be at least 18 years old.
  • Individuals who are part of a vulnerable population, such as those who cannot make decisions for themselves, are not eligible.
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Investigated drugs

Fosfomycin is being studied as an oral treatment option for acute bacterial prostatitis caused by multidrug-resistant Escherichia coli. This medication is being tested to see if it can effectively treat infections that are resistant to many other antibiotics. The trial aims to compare the effectiveness of fosfomycin with other approved treatments for infections caused by sensitive strains of E. coli.

What is already known about the treatment

Fosfomycin – Fosfomycin is administered orally and is being studied as a treatment for acute bacterial prostatitis caused by multidrug-resistant Escherichia coli. It is currently in a Phase IV clinical trial, which means it is being tested for effectiveness and safety in a larger population. The main therapeutic use of fosfomycin in this trial is to treat infections caused by bacteria that are resistant to multiple drugs. At the molecular level, fosfomycin works by inhibiting the synthesis of bacterial cell walls, which ultimately leads to the death of the bacteria. It is classified as an antibiotic and is being evaluated as an alternative to other approved treatments for this condition.

Investigated diseases

Acute Bacterial Prostatitis – This condition is an inflammation of the prostate gland caused by a bacterial infection, often involving Escherichia coli. It typically presents with sudden onset of symptoms such as fever, chills, pelvic pain, and urinary difficulties. The infection can lead to swelling and irritation of the prostate, causing discomfort and urinary retention. The bacteria responsible for the infection can be resistant to multiple drugs, complicating treatment. The condition requires prompt medical attention to manage symptoms and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-520012-18-00Estimated enrolment244 patientsSponsorFundacio Assistencial De Mutua De Terrassa Fpc

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