Daily Doxycycline for Early Syphillis

Description

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. Lab data support that taking the medication as a single daily dose should be effective as treatment, but it has not been studied clinically. The main question this study aims to answer is: Is doxycycline taken as a single daily dose of 200mg for 14 days an effective treatment for early syphilis based on a combined outcome of clinical improvement and blood test improvement? Participants will: 1. Take doxycycline 200mg daily for 14 days 2. Submit oral and rectal swabs that test for syphilis bacteria every other day for 2 weeks, returned by mail 3. Complete 2 brief online surveys over the first 2 weeks 4. Return to the clinic for an interview and blood draw every 3 months for a maximum of 3 study visits, including the first visit The investigators will compare the percentage of participants in the study who have response to treatment by 6 months to that of persons who have received standard (CDC-recommended) regimens. To do this, the investigators will calculate response percentage estimates following a shot of long-acting penicillin or 14 days of doxycycline 100mg twice daily from 60-person samples from the sexual health program's records.

Conditions

Syphilis

Study Overview

Study Details

Study overview

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. Lab data support that taking the medication as a single daily dose should be effective as treatment, but it has not been studied clinically. The main question this study aims to answer is: Is doxycycline taken as a single daily dose of 200mg for 14 days an effective treatment for early syphilis based on a combined outcome of clinical improvement and blood test improvement? Participants will: 1. Take doxycycline 200mg daily for 14 days 2. Submit oral and rectal swabs that test for syphilis bacteria every other day for 2 weeks, returned by mail 3. Complete 2 brief online surveys over the first 2 weeks 4. Return to the clinic for an interview and blood draw every 3 months for a maximum of 3 study visits, including the first visit The investigators will compare the percentage of participants in the study who have response to treatment by 6 months to that of persons who have received standard (CDC-recommended) regimens. To do this, the investigators will calculate response percentage estimates following a shot of long-acting penicillin or 14 days of doxycycline 100mg twice daily from 60-person samples from the sexual health program's records.

Daily Doxycycline for Early Syphillis

Daily Doxycycline for Early Syphillis

Condition
Syphilis
Intervention / Treatment

-

Contacts and Locations

Seattle

Public Health Sexual Health Clinic, Seattle, Washington, United States, 98104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • 1. 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 darkfield microscope exam of material taken from a chancre, OR
  • 2. 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
  • 3. A laboratory-confirmed diagnosis of early latent syphilis within one month (i.e. \<31 days prior).
  • 1. age under 18
  • 2. persons with evidence of neurosyphilis (including ocular and otic syphilis) or tertiary syphilis
  • 3. persons who are unable to give informed consent
  • 4. persons deemed by the study investigators to be unable to complete study follow-up visits
  • 5. persons with an allergy to doxycycline
  • 6. pregnant persons
  • 7. persons with HIV who report that they are off antiretroviral medication or that they are not virologically suppressed
  • 8. persons with other known forms of immunosuppression (e.g., persons taking systemic immunosuppressant drugs, persons with primary immunodeficiencies)
  • 9. persons taking medications that would interact with doxycycline
  • 10. persons whose initial RPR is lower than 1:4
  • 11. persons currently prescribed doxy PEP
  • 12. breastfeeding persons

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

University of Washington,

Travis Hunt, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

2025-10-16