All studies
Ongoing, recruitingPhase III and phase IV (Integrated)Interventional

Oral and Neuro-Penetrative Alternative Antibiotics for Patients with Syphilis

This study is helping doctors find new and effective ways to treat syphilis, a sexually transmitted infection. Currently, the most common treatment is an antibiotic called Benzathine Benzylpenicillin. In this study, doctors are comparing this standard treatment with a different antibiotic called Linezolid. They want to see which treatment is better at clearing up the infection, preventing it from returning, and how well it works if the infection has spread to the nervous system. Researchers will be monitoring participants to see if their symptoms improve, if the amount of the syphilis bacteria in their body goes down, and if they experience any side effects from the medication. This research aims to improve syphilis treatment options for people in the future.

At a glance

Status
Ongoing, recruiting
Phase
Phase III and phase IV (Integrated)
Sponsor
Fundacion Fls De Lucha Contra El Sida Las Enfermedades Infecciosas Y La Promocion De La Salud Y La Ciencia
Enrolment target
224
Start
23 Sep 2024

What is this study about?

Syphilis is a sexually transmitted infection that, if not treated, can cause serious health problems. The good news is that it can usually be cured with antibiotics. The most common treatment involves injections of an antibiotic called Benzathine Benzylpenicillin. However, doctors are always looking for even better ways to treat illnesses, especially if some people can't take the standard medication or if the infection is particularly stubborn.

This study is comparing the usual treatment for syphilis (Benzathine Benzylpenicillin) with a different antibiotic called Linezolid. Linezolid is already used for other infections, but doctors want to see if it's also a good choice for syphilis. They are particularly interested because Linezolid might be able to reach parts of the body, like the brain and nervous system, more effectively if the syphilis infection has spread there. The main goal is to find out if Linezolid is as good as, or even better than, the standard treatment at getting rid of the infection.

To figure this out, the researchers will be carefully observing people in the study. They will check if active sores or rashes clear up, if blood tests show that the infection is going away, and if the infection comes back after treatment. They'll also be looking closely for any side effects from the medications. All this information will help doctors understand which treatments work best for different people with syphilis and ultimately improve care for everyone affected by this infection.

Key takeaways

  • The study compares standard syphilis treatment with a new antibiotic.
  • It aims to find more effective ways to cure syphilis and prevent it from returning.
  • Participation involves regular clinic visits, blood tests, and close monitoring.
  • The study lasts about 11 months from your treatment start.
  • All treatment and follow-up care for the study will be provided by the research team.

Who may be eligible?

To join this study, you need to be at least 18 years old. Both men and women are welcome to take part. The study is specifically looking for people who have been diagnosed with syphilis.

More detailed checks will be done by the study team to make sure it's safe for you to participate and that the study is right for you. They will need to know about your general health and any other medications you might be taking. This is to ensure your well-being throughout the 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.

  1. Are you at least 18 years old?
  2. Have you been diagnosed with syphilis?
  3. Are you able to attend regular clinic appointments for about 11 months?
  4. Are you willing to have blood tests and physical examinations?
Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, the doctors and nurses will closely monitor your health. You will receive either the standard syphilis treatment (an injection) or the new antibiotic being tested (Linezolid). You will have regular visits to the clinic so the study team can check on your progress. These visits will involve physical examinations, blood tests, and possibly swabbing of any sores you might have. They will be looking to see if your syphilis symptoms improve and if the infection is clearing up.

Some participants might also have extra tests if their doctors suspect the infection has spread to other parts of their body, like the nervous system. The study will involve follow-up appointments over several months, specifically at 12, 24, and 48 weeks after starting treatment, to make sure the infection hasn't come back. The total duration of your involvement will be around 48 weeks (about 11 months) from when you start the treatment.

Potential risks and benefits

Taking part in this study may offer the benefit of receiving expert medical care for your syphilis and potentially access to a new treatment that could be more effective. However, as with any medication, there are potential risks, including side effects from the antibiotics. The study team will explain these in detail so you can make an informed decision. You are free 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.
  • Unverified
    Spain

Common questions

What is syphilis?

Syphilis is a sexually transmitted infection (STI) that can cause serious health problems if not treated.

What are the treatments being tested?

The study is comparing the standard syphilis treatment (an injection) with a new antibiotic called Linezolid.

How long will the study last?

If you join, you would be involved for about 48 weeks, which is roughly 11 months, including follow-up visits.

Will I know which treatment I'm getting?

In some studies, participants don't know which treatment they receive to keep the results fair. The study team will explain how this works.

Can I leave the study at any time?

Yes, you are free to stop participating in the study at any point, and your decision will not affect your future medical care.

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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