Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A randomized non-inferiority clinical trial of doxycycline vs BPG for early syphilis

This study is looking at new ways to treat early syphilis, a sexually transmitted infection. It compares two common medications: doxycycline (a tablet) and BPG (an injection). The main goal is to find out if doxycycline tablets work as well as BPG injections in treating the infection. Researchers will follow participants for 6 months to see how much the treatments reduce the syphilis infection. They will also look at any side effects, whether people take their medication correctly, and if they develop any other sexually transmitted infections. This study is for adults aged 18 and over, of any gender, who have early syphilis.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Assistance Publique Hopitaux De Paris

Enrolment target

200

Start

28 Jun 2024

early syphilis

What is this study about?

This study is a clinical trial designed to find the best way to treat early syphilis, a type of sexually transmitted infection. Currently, BPG (benzathine penicillin G) injections are a common treatment. However, this study wants to see if doxycycline, which is a tablet you can take by mouth, works just as effectively. If doxycycline proves to be as good as BPG, it could offer a more convenient and potentially easier treatment option for many people.

Researchers will compare how well doxycycline and BPG reduce the amount of the syphilis infection in your body. They'll measure this by looking at specific tests of your blood at the start of the study and then again at 6 months. For the treatment to be considered successful, the infection markers in your blood need to decrease significantly.

The study will also carefully monitor other important things. This includes keeping an eye on any serious side effects you might experience, making sure participants are taking their medication as prescribed, and checking for any other sexually transmitted infections that might develop during the study. This helps researchers get a full picture of how the treatments affect people.

Key takeaways

This study compares two treatments for early syphilis: tablets (doxycycline) and injections (BPG).
It aims to see if the tablet treatment works as well as the injection.
The study lasts for 6 months and involves regular clinic visits and blood tests.
Anyone aged 18 or over with early syphilis can consider taking part.
Your participation could help improve syphilis treatment for everyone.

Who may be eligible?

To join this study, you need to be an adult, aged 18 or older. The study is open to both men and women.

The most important requirement is that you have early syphilis. The study doctors will perform tests to confirm this before you can take part.

There might be other health conditions or medications you are taking that would prevent you from joining. The study team will discuss all of these details with you to make sure it's safe and appropriate for you to participate.

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 18 years old or older?
Do you have early syphilis?
Are you able to attend clinic appointments regularly for 6 months?
Are you comfortable with blood tests?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be assigned to either receive doxycycline tablets or BPG injections. You won't be able to choose which treatment you get. You will have regular appointments where the study team will monitor your health, perform blood tests to check the infection, and ask about any side effects you might be experiencing. If you are given doxycycline, they might also check how many tablets you've taken to make sure you're taking them correctly.

The study will run for a total of 6 months. During this time, you'll have several visits to the clinic for check-ups and tests. All your blood tests at the start and at 6 months will be done in the same lab to ensure accurate comparison.

Potential risks and benefits

Taking part in this study means you'll receive treatment for your early syphilis. You might benefit from the treatment if it successfully clears your infection. It also helps medical science understand the best ways to treat syphilis, which could help future patients. However, as with any medication, there's a chance of side effects from both doxycycline and BPG. The study team will explain these potential risks in detail. You have the right to withdraw from the study at any time, for any reason, without it affecting your 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
France

Common questions

What is early syphilis?

Early syphilis is a sexually transmitted infection. It can be treated with medicines like the ones being tested in this study.

What are VDRL and RPR tests?

These are blood tests used to check for syphilis infection and see how well the treatment is working. They measure certain markers in your blood.

Will I know which treatment I'm getting?

No, you won't know if you're getting doxycycline or BPG. This is to ensure the study results are fair and unbiased.

How long will I need to be in the study?

You will be in the study for a total of 6 months, with regular check-ups during that time.

Can I leave the study if I change my mind?

Yes, you can leave the study at any time, for any reason, and it won't affect your future medical care.