AuthorisedPhase III and phase IV (Integrated)Interventional

A randomized, double blind, double dummy, parallel group, multicenter clinical trial to evaluate the safety and clinical and microbiologic efficacy of oral fosfomycin calcium in adult womwn wiA th uUTI

This research study is investigating a medication called fosfomycin as a treatment for common urinary tract infections (UTIs) in adult women. The main goal is to find out how effectively fosfomycin helps clear up UTI symptoms, like pain or frequent urination, and whether it successfully gets rid of the bacteria causing the infection. Researchers will also be checking to make sure the medicine is safe to use. This kind of study helps doctors understand if a new medicine, or an existing one, is a good and safe choice for patients. Taking part would involve regular check-ups to see how you're feeling and to make sure the infection is gone.

At a glance

Status

Authorised

Phase

Phase III and phase IV (Integrated)

Sponsor

Asociacion Instituto De Investigacion Sanitaria Bioaraba, Laboratorios Ern S.A.

Enrolment target

384

Start

16 Dec 2024

Uncomplicated urinary tract infection (uUTI)

What is this study about?

This study is all about finding the best ways to treat simple urinary tract infections (UTIs) in women. We're specifically looking at a medicine called fosfomycin. You might have heard of UTIs – they're common infections that can make you feel uncomfortable, with symptoms like needing to pee often, a burning feeling, or pain in your lower tummy. Finding effective and safe treatments is very important so people can feel better quickly.

Our main aim is to see two things: first, if fosfomycin helps your UTI symptoms go away completely, and second, if it successfully clears the bacteria from your urine that caused the infection in the first place. We'll be checking these things carefully at a specific point during the study. We also want to understand if these improvements last over time.

This kind of study helps doctors make informed decisions about prescribing medicines. By carefully testing treatments, we can learn more about which ones work best, are safest, and offer the most relief for patients. Your participation could help improve future care for many women with UTIs.

Key takeaways

Tests fosfomycin for common UTIs in adult women.
Aims to check if symptoms clear and bacteria are gone.
Involves regular check-ups and urine tests.
Helps improve future UTI treatments.
Participation is voluntary and closely monitored.

Who may be eligible?

This study is looking for women aged 18 or older. You need to have a urinary tract infection (UTI) that your doctor believes is 'uncomplicated'. This means your UTI isn't linked to other serious health problems, and it's a common type that many women experience.

There will be other specific health requirements that the study doctors will check to make sure the study medicine is safe for you. For example, they'll check if you have certain other medical conditions or are taking particular medications that might affect how the study medicine works or make it unsafe.

The most important thing is that you're an adult woman with a simple UTI. The study team will explain all the details and help you understand if this study is right for you during your first visit.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you an adult woman (18 years or older)?
Have you been diagnosed with a simple, 'uncomplicated' UTI?
Are you willing and able to attend study appointments?
Are you comfortable providing urine samples?
Are you able to understand and sign a consent form?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you'll be given the study medicine, fosfomycin, to treat your UTI. You won't know if you're getting the active medicine or a comparison medicine, and neither will your study doctor – this is done to make the results as fair and accurate as possible. You'll need to attend several appointments at the clinic. During these visits, the study team will ask about your symptoms, give you check-ups, and take urine samples to see if the infection has cleared and if the medicine is working. These visits are important for tracking your progress and ensuring your safety. The total duration of your participation will depend on how quickly your infection clears and follow-up checks, but the study team will provide a clear timeline during your initial consultation.

Potential risks and benefits

Taking part in this study could offer the benefit of receiving treatment for your UTI and being closely monitored by medical professionals. You would also be contributing to important medical research that could help other women with UTIs in the future. As with any medicine, there's always a chance of side effects, which the study team will discuss with you. There might also be some discomfort from clinic visits or providing urine samples. Remember, joining a study is always your choice, and you are free to withdraw at any time without any impact on your standard medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is an 'uncomplicated' UTI?

An 'uncomplicated' UTI is a common type of urinary tract infection that happens in healthy women and isn't linked to other problems with the kidneys or bladder.

What is fosfomycin?

Fosfomycin is a type of antibiotic medication used to treat bacterial infections, like UTIs. This study aims to understand exactly how well it works for simple UTIs.

Will I know if I'm getting the real medicine?

No, neither you nor your study doctor will know if you're getting fosfomycin or a comparison medicine. This helps ensure the study results are fair and unbiased.

What kind of tests will I have?

You'll have regular check-ups, answer questions about your symptoms, and provide urine samples. These help the doctors see if the infection is going away and if you're feeling better.

How long will I be in the study?

The total length of your time in the study will depend on your individual response and follow-up plans, but the study team will give you a clear timeline when you join.