Active not recruitingPHASE3INTERVENTIONAL

Alternative Antibiotics for Syphilis

The Trep-AB study is looking into a new treatment for early syphilis, a sexually transmitted infection. Currently, the main treatment is an antibiotic injection called Benzathine Penicillin G. However, this injection doesn't easily reach the brain, where the syphilis bacteria can hide without causing immediate symptoms. This study is testing an oral antibiotic called Linezolid, which is known to reach the brain. Researchers want to see if Linezolid is as good as the standard penicillin injection in curing early syphilis. They are also investigating if this new treatment could help prevent serious brain-related complications in the future, offering a potentially more convenient and effective way to treat patients.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

Fundación FLS de Lucha Contra el Sida, las Enfermedades Infecciosas y la Promoción de la Salud y la Ciencia

Enrolment target

224

Start

14 Oct 2021

Estimated completion

01 Apr 2026

Early Latent Syphilis Primary Syphilis Secondary Syphilis

What is this study about?

Syphilis is a serious infection that is becoming more common worldwide. The bacteria that causes syphilis, called *Treponema pallidum*, can sometimes spread to the brain and spinal cord, even when patients don't have obvious symptoms. This hidden infection can potentially lead to more severe problems later on if not treated effectively. Our current main treatment, an antibiotic injection called Benzathine Penicillin G, doesn't easily cross into the brain, meaning that if the bacteria have already reached this area, the treatment might not be as effective in clearing them all out.

This study, called Trep-AB, is investigating a different antibiotic called Linezolid. Previous research has suggested that Linezolid might be effective against the syphilis bacteria and, importantly, it is known to be able to reach the brain. This study aims to see if Linezolid, which can be taken as a tablet, is as good as or even better than the current penicillin injection for treating early stages of syphilis (primary, secondary, and early latent).

The main goal is to find out if Linezolid is at least as effective as the standard penicillin treatment in curing early syphilis. Researchers will also be looking to understand more about the syphilis bacteria itself by studying samples from patients. This research is important because it could lead to a new, more convenient, and potentially more effective treatment option for syphilis, especially if it can help tackle the hidden infections in the brain and prevent future complications.

Key takeaways

This study compares a new oral antibiotic (Linezolid) with the standard syphilis injection (penicillin).
It aims to find a more effective treatment, especially for syphilis that might affect the brain.
Participation involves being randomly assigned to one of the two treatments and having follow-up visits.
The study is for people diagnosed with early syphilis (primary, secondary, or early latent).
It could lead to a more convenient and potentially better treatment option for syphilis.

Who may be eligible?

To join this study, you need to be an adult, 18 years or older, and have been diagnosed with early syphilis. This includes different stages like primary syphilis (where you might have a sore), secondary syphilis (with rashes or other symptoms), or early latent syphilis (where you have a positive test but no obvious symptoms).

There are also some important rules for women who could become pregnant and for men. If you are a woman who could get pregnant, you must be using a very effective form of contraception (like the pill, an IUD, or choosing not to have sex) for one week after your last study medication. If you are a man, you must use a condom during sex and your female partner must also use very effective contraception for one week after your last study medication. You also need to be able to understand and sign an informed consent form and follow the study instructions.

Diagnoses of syphilis will be checked using specific guidelines. In some cases, a rapid test might be used for initial screening, especially if you haven't had syphilis before or if your previous tests were negative.

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?
Have you recently been diagnosed with primary, secondary, or early latent syphilis?
Are you able to provide your written consent to join the study?
If you are a woman who could become pregnant, are you using very effective contraception (or planning to) for one week after treatment?
If you are a man, are you using condoms and ensuring your female partner uses very effective contraception (or planning to) for one week after treatment?

Answer every question to see your result.

What does participation involve?

If you join the Trep-AB study, you would first have an initial visit to confirm your eligibility and signs all necessary forms. You would then be randomly assigned to receive either the new antibiotic, Linezolid (as tablets), or the standard treatment, Benzathine Penicillin G (as an injection). The duration of your treatment and the number of doses will depend on which treatment you receive. You will have regular follow-up visits with the study team to monitor your health and how well the treatment is working. These visits will involve blood tests and possibly other assessments. The total duration of your participation in the study is not specified but will likely involve several months of monitoring after your initial treatment.

Potential risks and benefits

Participating in this study could offer several potential benefits. You would receive treatment for your syphilis, and if assigned to the new drug, Linezolid, you might benefit from a treatment that is easier to take (oral instead of injection) and potentially better at reaching hidden infections in the brain. However, there are also potential risks, as with any medical treatment. Linezolid is a known antibiotic, but side effects can occur, and it might not be as effective as the standard treatment. The standard penicillin injection can also have side effects, including allergic reactions. You will be closely monitored throughout the study to identify and manage any side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (6)

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

CAP Drassanes-Hospital Universitari Vall d'Hebron
Verified postcode
Barcelona, Spain
Barcelona Checkpoint
Verified postcode
Barcelona, Spain
Hospital Clínic de Barcelona
Verified postcode
Barcelona, Spain
Hospital Germans Trias Pujol
Verified postcode
Barcelona, Spain
Hospital 12 de Octubre
Verified postcode
Madrid, Spain
Mortimer Market Centre
Verified postcode
London, United Kingdom

Common questions

What is early latent syphilis?

This means you have tested positive for syphilis, but don't have any obvious symptoms, and the infection happened fairly recently (within the last year).

Why is the study looking at a new drug if there's already a treatment?

The current treatment doesn't easily reach the brain, where syphilis can sometimes hide. This study is looking for a new treatment that might work better for these hidden infections and could be easier to take (oral instead of injection).

Will I know which treatment I'm getting?

No, this is a 'randomised controlled trial', meaning you will be randomly assigned to either the new drug or the standard treatment, and you won't know which one you're receiving to keep the study fair.

What is 'randomised controlled clinical trial'?

This means participants are put into treatment groups by chance, like flipping a coin. This helps make sure the results are fair and not influenced by other factors, so we can clearly see if the new treatment works.

What should I do if I think I have syphilis?

If you suspect you have syphilis, please contact your local sexual health clinic or GP for advice and testing. They can provide accurate diagnosis and treatment.