AuthorisedTherapeutic use (Phase IV)Interventional

FOSFOMYCIN AS AN ORAL ALTERNATIVE THERAPY IN THE TREATMENT OF ACUTE BACTERIAL PROSTATITIS CAUSED BY MULTIDRUG-RESISTANT ESCHERICHIA COLI. PILOT STUDY

This study is exploring if an oral antibiotic called fosfomycin can be used to treat acute bacterial prostatitis. This is a sudden and severe infection of the prostate gland in men. Specifically, it's for infections caused by *E. coli* bacteria that are resistant to many other antibiotics. The study is for men who have started treatment in the hospital with an intravenous antibiotic (given into a vein) for 1 to 5 days, and are now stable enough to switch to a pill. Researchers want to see how well fosfomycin works when taken by mouth to clear up this type of prostate infection. It's a pilot study, meaning it's a small-scale, early look at this treatment.

At a glance

Status

Authorised

Phase

Therapeutic use (Phase IV)

Sponsor

Fundacio Assistencial De Mutua De Terrassa Fpc

Enrolment target

244

Start

21 Jan 2025

Prostatitis aguda bacteriana (PAB) por Escherichia coli multirresitente.

What is this study about?

This research study is about finding better ways to treat a prostate infection called acute bacterial prostatitis (PAB). The prostate is a small gland in men, located just below the bladder, which plays a role in reproduction. When it gets infected, it can be very painful and cause serious health problems. This study is focusing on cases where the infection is caused by a type of bacteria called *E. coli*.

The particular challenge this study addresses is when these *E. coli* bacteria are 'multidrug-resistant'. This means they are very tough and don't respond to many common antibiotics, making the infection harder to treat. Traditionally, these types of infections often require long courses of antibiotics given through a drip in a hospital.

Researchers are investigating whether an antibiotic called fosfomycin, when taken as a pill (known as oral therapy), can effectively treat these difficult-to-cure prostate infections. This could be a really important step because it might mean that men with this condition could finish their treatment at home with tablets, rather than needing to stay in the hospital for a long time. It's a pilot study, which means it’s an initial, smaller study to see if this approach is promising before potentially conducting larger studies.

Key takeaways

The study explores an oral antibiotic (fosfomycin) for prostate infections.
It targets severe prostate infections caused by difficult-to-treat *E. coli* bacteria.
This could mean finishing treatment at home with pills instead of long hospital stays.
The study is for adult men who have already started hospital treatment.
It's a small, early-stage study to see how well this treatment works.
Participating could help improve future care for men with similar conditions.

Who may be eligible?

To be able to join this study, you need to be an adult man, at least 18 years old or older. The study is looking for men who have an infection of their prostate gland, specifically 'acute bacterial prostatitis', caused by a type of bacteria called *E. coli*.

Crucially, this *E. coli* infection must be confirmed to be resistant to several common antibiotics, but sensitive to fosfomycin, meaning fosfomycin should have a good chance of working against it. You also need to have already started treatment in hospital with an antibiotic given through a drip for between 1 and 5 days, and be feeling stable and well enough to switch to oral medication.

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 man (18 years or older)?
Do you have a sudden prostate infection called acute bacterial prostatitis?
Is your prostate infection caused by *E. coli* bacteria that are hard to treat with other medicines?
Have you already received 1 to 5 days of antibiotics through a drip in hospital?
Are you stable and well enough to consider switching to oral medication?
Has your doctor confirmed your infection is sensitive to fosfomycin?

Answer every question to see your result.

What does participation involve?

The specific details of what taking part in this study involves aren't fully described in the summary. However, typically for a study like this, you would likely: * Have various medical tests and check-ups to confirm you meet all the study requirements. * Receive the allocated study medication, fosfomycin, as a tablet to take by mouth after your initial hospital antibiotic treatment. * Have regular follow-up appointments, which may include blood tests, urine tests, and physical examinations, to check how well the treatment is working and to monitor for any side effects. * The total duration of your participation would depend on the standard treatment course for acute prostatitis and the follow-up schedule designed by the researchers, which often spans several weeks to ensure the infection is fully cleared.

Potential risks and benefits

Potential benefits of taking part could include receiving an oral antibiotic that might be very effective against your difficult-to-treat prostate infection, potentially allowing you to complete treatment outside of the hospital. You would also be contributing to medical knowledge that could help future patients. Potential risks could include side effects from the fosfomycin, such as stomach upset, headache, or other reactions, although these are usually mild. As with any study, there's always a possibility the treatment may not work as expected. You are always free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
Spain

Common questions

What is the prostate gland?

The prostate is a small gland in men, located below the bladder. It plays a role in producing fluid that helps sperm.

What does 'acute bacterial prostatitis' mean?

It means you have a sudden and severe infection of your prostate gland caused by bacteria. 'Acute' means sudden, and 'bacterial' means it's caused by germs.

What does 'multidrug-resistant' *E. coli* mean?

It means the *E. coli* bacteria causing your infection are very strong and don't respond to many common antibiotics, making them harder to treat.

What is fosfomycin?

Fosfomycin is an antibiotic, a type of medicine used to kill bacteria. In this study, it's being given as a pill.

Is this a new medicine?

Fosfomycin itself is an established antibiotic, but this study is looking at its use specifically as an oral option for this challenging type of prostate infection, after some initial hospital treatment.