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Study on the Safety and Effectiveness of Fosfomycin Calcium for Treating Uncomplicated Urinary Tract Infections in Adult Women

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 uncomplicated urinary tract infections (uUTI) in adult women. The treatment being tested is an oral medication called fosfomycin calcium, which is a type of antibiotic. The purpose of the study is to evaluate the safety and effectiveness of this medication in resolving the symptoms and bacterial causes of uUTI.

Participants in the study will receive either the medication being tested or a different form of the same antibiotic, known as fosfomycin trometamol. The study is designed to compare the two forms to see if fosfomycin calcium is as effective as fosfomycin trometamol in treating uUTI. The trial will be conducted in a way that neither the participants nor the researchers know which treatment is being given, ensuring unbiased results.

The study will take place over a period of time, during which participants will be monitored for their response to the treatment. This includes checking for the resolution of uUTI symptoms and ensuring that the bacterial infection is reduced. The trial aims to provide valuable information on the effectiveness of fosfomycin calcium in treating uncomplicated urinary tract infections in women.

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

    Initial assessment

    Upon joining the study, an initial assessment is conducted to confirm eligibility. This includes verifying that you are an adult woman with signs of an uncomplicated urinary tract infection (uUTI).

    Signs of uUTI include frequent urination, urgent need to urinate, pain or burning during urination, and/or pain in the lower abdomen.

    A urine test is performed to check for signs of infection, such as the presence of white blood cells.

  2. Step 2

    Treatment phase

    You will be randomly assigned to receive either fosfomycin calcium or a comparison treatment. This is done to evaluate the effectiveness of the medication.

    The medication is taken orally. The specific dosage and frequency will be provided by the study team.

    The treatment aims to resolve the symptoms of uUTI and reduce the bacteria causing the infection.

  3. Step 3

    Follow-up visits

    Regular follow-up visits are scheduled to monitor your progress and assess the effectiveness of the treatment.

    During these visits, your symptoms will be evaluated, and additional urine tests may be conducted to check for bacterial reduction.

  4. Step 4

    End of treatment evaluation

    At the end of the treatment period, a final evaluation is conducted to determine the clinical and microbiological response.

    The goal is to confirm the resolution of uUTI symptoms and ensure that the bacterial count in the urine is significantly reduced.

Who can join the trial?

5 criteria

  • Must be an adult woman, aged 18 years or older, with an initial uncomplicated urinary tract infection (uUTI).
  • Must have at least two of the following signs of uUTI: needing to urinate frequently, feeling an urgent need to urinate, experiencing pain or burning during urination, or having pain in the lower stomach area.
  • Must provide a mid-stream urine sample that shows signs of infection, specifically a positive result for leukocyte esterase, which indicates the presence of white blood cells in the urine.
  • If a woman is of childbearing potential, she must use effective birth control methods as recommended by the Clinical Trial Facilitation Group (CTFG).
  • Must be able to communicate effectively and provide written consent to participate in the study.

Who cannot join the trial?

2 criteria

  • Men cannot participate in the study. Only women are eligible.
  • Individuals who are part of a vulnerable population cannot participate. This means people who might need special protection or care.
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Investigated drugs

  • Fosfomycin Calcium

    is an oral medication being tested for its ability to treat urinary tract infections (UTIs) in adult women. The trial aims to determine if this form of fosfomycin is as effective in resolving the infection and its symptoms as another form of the medication.

  • Fosfomycin Trometamol

    is another form of fosfomycin used as a comparison in the trial. It is already known for its effectiveness in treating UTIs, and the study is comparing it to fosfomycin calcium to see if they work equally well.

What is already known about the treatment

  • Fosfomycin Calcium

    This medication is administered orally and is currently being evaluated in clinical trials for its effectiveness in treating uncomplicated urinary tract infections (uUTIs) in adult women. It is being compared to fosfomycin trometamol to determine if it is equally effective. Fosfomycin calcium works by inhibiting bacterial cell wall synthesis, which helps eliminate the infection. It is classified as an antibiotic and is being studied to confirm its safety and efficacy in medical use.

  • Fosfomycin Trometamol

    This medication is also administered orally and is used to treat uncomplicated urinary tract infections. It is well-established in medical literature as an effective treatment for this condition. The drug works by blocking the formation of the bacterial cell wall, leading to the death of the bacteria causing the infection. Fosfomycin trometamol is classified as an antibiotic and is being used as a comparator in clinical trials to evaluate the efficacy of fosfomycin calcium.

Investigated diseases

Uncomplicated Urinary Tract Infection (uUTI) – This condition occurs when bacteria infect the urinary tract, which includes the bladder and urethra, without involving the kidneys or causing severe symptoms. It is more common in women and typically presents with symptoms such as a frequent urge to urinate, a burning sensation during urination, and cloudy or strong-smelling urine. The infection is considered "uncomplicated" because it occurs in a healthy urinary tract and does not lead to more serious health issues. The bacteria responsible for uUTI often originate from the digestive tract and enter the urinary system through the urethra. If left untreated, the infection can persist, but it usually resolves with appropriate management.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase ITrial ID2024-518646-24-00Protocol codeEfFoCa2021Estimated enrolment384 patientsSponsorAsociacion Instituto De Investigacion Sanitaria Bioaraba

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