Recruiting PHASE2 Syphilis

New treatment option for Syphilis

Official title Daily Doxycycline for Early Syphillis

ClinicalTrials.gov ID: NCT06683638

What this study is testing

What is Doxycycline 200mg daily for 14 days?

Doxycycline 200mg daily for 14 days is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for syphilis.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
The goal of this clinical trial is to learn if doxycycline taken as 200mg daily for 14 days is effective to treat early stage syphilis. This is different from how doxycycline is typically used for syphilis because the full doxycycline dose will be taken at the same time of day, rather than split up into a twice daily regimen.
  • Phase 2: a mid-size study of how well it works

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 and older

You may be able to join if

  • Clinical diagnosis of syphilis (primary or secondary) or laboratory-confirmed early latent syphilis. Specifically: This will include persons meeting...
  • Clinical diagnosis of primary syphilis (based on the presence of a chancre) and either a positive qualitative RPR in the absence of a prior positive...
  • Clinical diagnosis of secondary syphilis with a positive qualitative RPR in the absence of a prior positive RPR on their most recent serological test...
  • A laboratory-confirmed diagnosis of early latent syphilis within one month (i.e. \<31 days prior).

You likely can't join if

  • age under 18
  • persons with evidence of neurosyphilis (including ocular and otic syphilis) or tertiary syphilis
  • persons who are unable to give informed consent
  • persons deemed by the study investigators to be unable to complete study follow-up visits
  • persons with an allergy to doxycycline
  • pregnant persons
See the full eligibility criteria
Who can join
  • Clinical diagnosis of syphilis (primary or secondary) or laboratory-confirmed early latent syphilis. Specifically: This will include persons meeting any one of the following criteria:
  • Clinical diagnosis of primary syphilis (based on the presence of a chancre) and either a positive qualitative RPR in the absence of a prior positive RPR on their most recent serological test for syphilis or a positive...
  • Clinical diagnosis of secondary syphilis with a positive qualitative RPR in the absence of a prior positive RPR on their most recent serological test for syphilis, OR
  • A laboratory-confirmed diagnosis of early latent syphilis within one month (i.e. \<31 days prior).
What rules you out
  • age under 18
  • persons with evidence of neurosyphilis (including ocular and otic syphilis) or tertiary syphilis
  • persons who are unable to give informed consent
  • persons deemed by the study investigators to be unable to complete study follow-up visits
  • persons with an allergy to doxycycline
  • pregnant persons
  • persons with HIV who report that they are off antiretroviral medication or that they are not virologically suppressed
  • persons with other known forms of immunosuppression (e.g., persons taking systemic immunosuppressant drugs, persons with primary immunodeficiencies)
  • persons taking medications that would interact with doxycycline
  • persons whose initial RPR is lower than 1:4
  • persons currently prescribed doxy PEP
  • breastfeeding persons Persons whose initial laboratory serological tests do not confirm the diagnosis of syphilis with an RPR of 1:4 or higher will be informed that they do not meet study criteria and advised to...

The study team makes the final eligibility decision.

Where it's taking place

  • Seattle, Washington, United States

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Seattle, Washington, United States. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.