Multicentre study evaluating the efficacy of a 7-day course of doxycycline for the treatment of asymptomatic anal lymphogranuloma venereum SHORT-LGV
This research is looking into a 7-day course of doxycycline, an antibiotic, to see how well it treats an anal infection called Lymphogranuloma Venereum (LGV). Specifically, it's for men who have this infection but don't have any symptoms (asymptomatic). The main goal is to find out if the treatment completely gets rid of the infection, meaning a test taken four weeks after starting treatment shows no signs of LGV. The study will also look at different types of the LGV bacteria, check if the treatment fails or if someone gets re-infected, and monitor for any side effects from the medication. This is an early stage study to understand the treatment's effectiveness.
At a glance
What is this study about?
This study is about an infection called Lymphogranuloma Venereum, or LGV for short. It's an infection that can affect the bottom area (anal area), and often people don't even know they have it because it doesn't cause any symptoms. This research focuses on men who have tested positive for LGV in their anal area but aren't experiencing any problems from it.
The main aim of the study is to see if a common antibiotic called doxycycline can clear up this infection. Participants will take doxycycline for seven days. After four weeks, doctors will re-test to see if the infection has gone away. This helps researchers understand if this treatment is effective for this specific type of LGV.
Researchers will also be looking at other things, like the particular type of LGV bacteria someone has, whether the treatment works completely or if the infection comes back, and how well people stick to taking their medication. They'll also carefully watch out for any side effects from the doxycycline. This is a "Phase II" study, which means it's an early-stage trial trying to find out if a treatment works and is safe enough to investigate further.
Key takeaways
- This study tests a 7-day doxycycline treatment for asymptomatic anal LGV.
- It's for men aged 18 and over who have the infection but no symptoms.
- The main goal is to see if doxycycline successfully clears the infection.
- You'll take pills for 7 days and have a follow-up visit after 4 weeks.
- Any side effects will be closely monitored by the study team.
Who may be eligible?
This study is specifically looking for men who are 18 years old or older. There isn't an upper age limit mentioned.
To be considered for this study, you must have an active LGV infection in your anal area, but crucially, you must not have any symptoms or feel unwell because of it. The study will confirm this with a specific test.
- Are you a man?
- Are you 18 years old or older?
- Have you tested positive for LGV in your anal area?
- Do you currently have no symptoms from your LGV infection?
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'll be given the antibiotic doxycycline to take for seven days. You'll need to keep a diary to help track whether you're taking the medicine as prescribed. You'll have an initial visit where tests will be done, and then you'll need to attend a follow-up visit four weeks after you start the treatment. At this follow-up, doctors will take more samples to see if the infection has cleared up and also check for any side effects you might have had. The total time you'd be involved in the study from start to finish would be about four weeks.
Potential risks and benefits
Locations (1)
- —France
Common questions
What is LGV?
LGV stands for Lymphogranuloma Venereum. It's a type of sexually transmitted infection caused by specific strains of Chlamydia trachomatis bacteria.
What does 'asymptomatic' mean?
Asymptomatic means you have an infection but aren't experiencing any signs or symptoms of it. You might not even know you have it without a test.
Is doxycycline a common medication?
Yes, doxycycline is a widely used antibiotic that treats various bacterial infections.
Will I know if the treatment worked?
Yes, at your follow-up visit, doctors will perform a test to see if the LGV infection has cleared, and you will be informed of the results.
Do I need to change my sexual activity during the study?
The study will gather information about your sexual activity during the study period, including condom use, to help understand re-infection or treatment failure.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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