A randomized controlled non-inferiority trial comparing 7 versus 14 days of ciprofloxacin for male urinary tract infections with systemic involvement.
This study is investigating the best way to treat severe urine infections in men. These are urine infections that have spread and are making the person feel generally unwell, for example, with a high temperature or back pain. The doctors want to find out if taking an antibiotic called ciprofloxacin for 7 days is just as good as taking it for the usual 14 days. They are looking to see if the symptoms go away and stay away, and if there are fewer side effects with the shorter treatment. If successful, it could mean men need to take less medicine, which is often better for them.
At a glance
What is this study about?
This study is about making sure men with more serious urine infections get the best and most effective treatment. When a urine infection becomes severe, it means the infection has spread from the bladder to other parts of the body, which can cause symptoms like a high temperature, pain in the back or side, or feeling very unwell. Doctors call this a 'urinary tract infection with systemic involvement'.
The study is trying to answer an important question: can a shorter course of antibiotics still be effective for these more serious infections? Currently, men with these types of infections often take antibiotics for 14 days. This study will compare that longer treatment to a 7-day course of the same antibiotic, called ciprofloxacin. They want to see if the 7-day course works just as well to get rid of the infection and stop the symptoms from returning, while potentially causing fewer side effects.
This kind of research is very important because finding shorter, yet equally effective, treatments can reduce the amount of medication people need to take, which might lead to fewer side effects and could help prevent antibiotic resistance in the long run. By taking part, men can help doctors understand the best way to treat these infections in the future.
Key takeaways
- Study compares 7-day vs. 14-day antibiotic treatment for severe male urine infections.
- Specifically for men aged 18 and over with symptoms like fever or back pain from UTI.
- Aims to see if shorter treatment is just as effective and has fewer side effects.
- Participation involves taking medication, clinic visits, and follow-up for about 6-7 weeks.
- You will be randomly assigned to one of the treatment lengths.
Who may be eligible?
This study is specifically looking for men aged 18 or over. There is no upper age limit, so men of any adult age can potentially take part.
To be considered for the study, you must have a urine infection that has spread and is making you feel generally poorly. This means you might have symptoms like a high temperature (over 38°C), pain in your side or back, very low blood pressure, or blood test results that show high levels of inflammation linked to your infection. The doctors will check your medical history and do some tests to confirm if your infection fits these criteria.
You cannot be pregnant or breastfeeding if you are a man. Only men are eligible for this study.
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 male?
- Are you 18 years old or older?
- Do you have a urine infection that has made you feel generally unwell (e.g., with a high temperature or back pain)?
- Have you recently been diagnosed with a urine infection by a doctor that is causing other body-wide symptoms?
What does participation involve?
If you join this study, you will be randomly assigned to one of two groups: one group will receive the study antibiotic (ciprofloxacin) for 7 days, and the other group will receive it for 14 days. During the study, you will take the medicine as prescribed. You will have regular check-ups with the study team. These check-ups will involve discussing your symptoms, and possibly having blood tests or urine tests to see how you are responding to the treatment and to check for any side effects.
The main part of the study involves monitoring your health for about 28 days after you finish taking your antibiotics. This is to see if your symptoms have completely gone away, if the infection returns, or if you experience any side effects from the medication. The total time you would be involved in the study, from starting treatment to the final follow-up, would be around 6-7 weeks.
Potential risks and benefits
Locations (1)
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Common questions
What is ciprofloxacin?
Ciprofloxacin is a common antibiotic used to treat various bacterial infections, including urine infections.
What does 'systemic involvement' mean for my urine infection?
It means the infection has spread beyond your bladder and is making you feel unwell throughout your body, often with symptoms like a fever or back pain.
Will I definitely get the shorter 7-day treatment?
No, you will be randomly assigned to either the 7-day or 14-day treatment group, like picking names out of a hat. You won't be able to choose.
What if my symptoms come back after the treatment?
The study team will monitor you closely for this. If your symptoms return, they will assess you and ensure you receive appropriate medical care.
Will I have to pay to be in the study?
No, participating in a clinical trial like this is free. All study-related care and medication will be provided by the research team.
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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