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Study on the Effectiveness of Fosfomycin, Cefixime, and Ciprofloxacin in Treating Acute Bacterial Prostatitis in Adult Men

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 causes inflammation of the prostate gland due to bacterial infection. The study will compare the effectiveness of two oral medications: Fosfomycin and Cefixime. Additionally, Ciprofloxacin Hydrochloride is another medication involved in the study. These medications are known as antimicrobials, which help fight infections caused by bacteria.

The purpose of the study is to evaluate how well these medications can resolve urinary symptoms associated with acute bacterial prostatitis. Participants will be randomly assigned to receive one of the medications or a placebo. The study will monitor the reduction of symptoms such as fever and urinary discomfort over a period of 6 to 10 days after the end of the treatment. The study aims to determine if the medications can effectively cure the infection without the need for additional antibiotics.

Participants will take the medication orally, and the treatment period will last up to 20 days. The study will involve regular check-ups to assess the improvement of symptoms and ensure the safety of the participants. The ultimate goal is to find the most effective treatment option for acute bacterial prostatitis, helping patients recover from this condition more efficiently.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, the patient must meet specific criteria, including being male, 18 years or older, and diagnosed with acute bacterial prostatitis. This condition is characterized by sudden urinary symptoms, a fever of at least 37.8°C, and the presence of bacteria or white blood cells in urine.

    The patient must have received appropriate intravenous antibiotics for at least 24 to 96 hours before starting the trial.

  2. Step 2

    Randomization and treatment assignment

    The patient will be randomly assigned to receive one of the following oral medications: fosfomycin, cefixime, or ciprofloxacin hydrochloride. These medications are used to treat bacterial infections and will be administered orally.

  3. Step 3

    Treatment phase

    During the treatment phase, the patient will take the assigned medication as directed. The dosage and frequency will be determined by the study protocol and the patient's specific needs.

    The treatment aims to resolve urinary symptoms and reduce fever related to the infection.

  4. Step 4

    Post-treatment evaluation

    After completing the treatment, the patient will be evaluated 6 to 10 days later to assess the clinical cure. This involves checking for a reduction in initial symptoms and ensuring no additional systemic antibiotics are needed for the urinary tract infection.

    The goal is to confirm that the patient is alive and has experienced a reduction in all initial local and systemic symptoms.

Who can join the trial?

11 criteria

  • Must be a male (born male) who is at least 18 years old.
  • Must have been diagnosed with acute bacterial prostatitis. This means:
    • Sudden appearance of urination problems, which can be either irritating or blocking.
    • Having a body temperature of 37.8°C or higher.
    • Presence of bacteria or white blood cells in a urine sample taken without prostate massage.
    • No signs of pyelonephritis, which is a kidney infection that can cause pain in the back or side.
    • Must have received appropriate intravenous antibiotics for at least 24 to 96 hours.
    • Must have a urine or blood test showing an enterobacterales microorganism that is sensitive to at least two specific drugs: ciprofloxacin, fosfomycin, or cefixime.
    • Must be able to understand and follow the study's requirements, instructions, and restrictions.
    • Must be likely to complete the study as planned.
    • Must be suitable for participating in a clinical trial with oral medication. This means no active substance abuse, no severe organ disease, and no long-term work assignments outside the country.
    • Must not meet any exclusion criteria and must be able to give consent for data collection and analysis.

Who cannot join the trial?

3 criteria

  • Patients who are not male cannot participate in the study.
  • Patients who are younger than 18 years old or older than 65 years old cannot participate in the study.
  • Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate in the study.
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Investigated drugs

  • Fosfomycin Trometamol

    is an antibiotic used in this trial to treat acute bacterial prostatitis. It works by killing the bacteria causing the infection, helping to reduce symptoms such as pain and difficulty urinating. The goal is to see if it effectively resolves urinary symptoms within 6-10 days after treatment ends.

  • Cefixime

    is another antibiotic being tested in the trial for the treatment of acute bacterial prostatitis. Like Fosfomycin Trometamol, it aims to eliminate the bacteria responsible for the infection, thereby alleviating symptoms. The trial compares its effectiveness to that of Fosfomycin Trometamol in achieving a clinical cure.

What is already known about the treatment

  • Fosfomycin Trometamol

    This medication is administered orally and is currently being studied for its effectiveness in treating acute bacterial prostatitis. It is well-documented in medical literature as an antibiotic used to treat various bacterial infections. The main therapeutic indication for Fosfomycin Trometamol in this trial is to resolve urinary symptoms associated with acute bacterial prostatitis. At the molecular level, it works by inhibiting bacterial cell wall synthesis, leading to the destruction of the bacteria. It is classified pharmacologically as a broad-spectrum antibiotic.

  • Cefixime

    This medication is also administered orally and is being evaluated in clinical trials for its role in treating acute bacterial prostatitis. Cefixime is recognized in medical literature as an effective antibiotic for various bacterial infections. Its primary therapeutic use in this trial is to alleviate urinary symptoms caused by acute bacterial prostatitis. The mechanism of action involves inhibiting bacterial cell wall synthesis, which results in bacterial cell death. It belongs to the pharmacological class of cephalosporin antibiotics.

Investigated diseases

Acute bacterial prostatitis – This is a sudden bacterial infection of the prostate gland, which can cause inflammation and swelling. It often presents with symptoms such as fever, chills, pelvic or lower back pain, and painful urination. The condition can also lead to urinary retention or difficulty urinating due to swelling of the prostate. It is typically caused by bacteria that travel from the urinary tract or bloodstream to the prostate. The disease progresses rapidly and requires prompt medical attention to manage symptoms and prevent complications.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-513465-39-00Protocol codeCEFOSPROSTEstimated enrolment276 patientsSponsorFundacio Hospital Universitari Vall D’Hebron Institut De Recerca

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