Exploratory Pragmatic trial of fosfomycin-trometamol treatment of male urinary tract infections in primary care.
This study is testing a specific antibiotic medicine, called fosfomycin, to see how well it treats urine infections in adult men. It’s a 'Phase 3' study, which means the medicine has already been studied and is now being tested on a larger group of people to confirm its effects. The researchers want to find out if taking fosfomycin helps men fully recover from their urine infection without needing different antibiotics, hospital stays, or seeing their doctor again for worsening symptoms. They will also be checking if patients still feel better after a few weeks and months, and if there are any side effects. This study aims to see if this single-dose treatment could be a good option for men with urine infections.
At a glance
What is this study about?
This study is about a medicine called fosfomycin, which comes as a powder to mix in water and drink. Doctors are looking into how effective it is for treating urine infections in men, specifically those infections treated by their GP, not in hospital. A urine infection, sometimes called a UTI, happens when germs get into the urinary system and cause symptoms like pain when peeing, needing to pee often, or tummy pain. While urine infections are very common in women, they can be more serious in men and sometimes need different treatment.
The main goal of this particular study is to see if fosfomycin successfully clears up the infection and makes men feel better, so they don't need further treatment, hospital visits, or get worse symptoms within two weeks of finishing the medicine. The research will also look at whether symptoms improve over several weeks and months, if the infection truly goes away, and if there are any side effects from the treatment. This kind of study, called a Phase 3 trial, is an important step in understanding if new treatments are safe and effective for wider use.
By taking part, you would be helping doctors and researchers understand more about the best ways to treat urine infections in men. This could lead to better and simpler treatment options in the future, improving care for many people.
Key takeaways
- Tests a single-dose antibiotic (fosfomycin) for men's urine infections.
- Aims to see if it cures the infection and improves symptoms.
- Checks for side effects and how patients feel over several months.
- Only adult men (18+) with a urine infection can join.
- Helps doctors find better treatments for men's urine infections.
Who may be eligible?
This study is looking for men aged 18 and over who have a urine infection. You would need to be diagnosed with a urine infection by your doctor to be considered for this study.
It's important that you are a man, as the study is specifically focusing on how this treatment works in the male body. You must also be an adult, 18 years old or older, to participate.
- Am I a man?
- Am I 18 years old or older?
- Have I recently been diagnosed with a urine infection?
- Am I able to attend follow-up appointments/provide samples as needed for about 3 months?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you would receive the study medicine, fosfomycin, as a single dose. Researchers would then follow up with you to see how you are doing. This includes checking if your symptoms improve at different times – usually around 2-5 days, then again at 28-35 days, and then about 3 months after you start the medicine. You might be asked to provide urine samples around 2-3 weeks and again at 10-12 weeks after finishing the medicine to check if the infection has truly gone. Your study doctor would also keep track of any side effects you experience during the treatment and for about two weeks afterwards. The total time you would be involved in the study from taking the medicine to the final checks would likely be around 3 months.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is a 'Phase 3' study?
A Phase 3 study checks if a new medicine works well and is safe in a larger group of people, confirming what earlier studies found.
What is the medicine being tested?
The medicine being tested is called fosfomycin. It's an antibiotic used to treat infections.
Who can take part in this study?
Adult men, aged 18 or older, who have a urine infection can potentially take part.
What if the medicine doesn't work for me?
If the study medicine doesn't clear your infection, your doctor will adjust your treatment, possibly giving you a different antibiotic.
How long will I be involved in the study?
You would be involved for about 3 months from the time you take the medicine until the final check-ups.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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