RECRUITING

Daily Doxycycline for Early Syphillis

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

Daily Doxycycline for Early Syphillis

Quick Facts

Study Start:2025-03-03
Study Completion:2025-10-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06683638

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 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. 3. A laboratory-confirmed diagnosis of early latent syphilis within one month (i.e. \<31 days prior).
  1. 1. age under 18
  2. 2. persons with evidence of neurosyphilis (including ocular and otic syphilis) or tertiary syphilis
  3. 3. persons who are unable to give informed consent
  4. 4. persons deemed by the study investigators to be unable to complete study follow-up visits
  5. 5. persons with an allergy to doxycycline
  6. 6. pregnant persons
  7. 7. persons with HIV who report that they are off antiretroviral medication or that they are not virologically suppressed
  8. 8. persons with other known forms of immunosuppression (e.g., persons taking systemic immunosuppressant drugs, persons with primary immunodeficiencies)
  9. 9. persons taking medications that would interact with doxycycline
  10. 10. persons whose initial RPR is lower than 1:4
  11. 11. persons currently prescribed doxy PEP
  12. 12. breastfeeding persons

Contacts and Locations

Study Contact

Travis Hunt, MD
CONTACT
206-685-4456
thunt91@uw.edu
Matthew Golden, MD, MPH
CONTACT
206-744-6829
golden@uw.edu

Principal Investigator

Travis Hunt, MD
PRINCIPAL_INVESTIGATOR
University of Washington

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: University of Washington

  • Travis Hunt, MD, PRINCIPAL_INVESTIGATOR, University of Washington

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-03-03
Study Completion Date2025-10-16

Study Record Updates

Study Start Date2025-03-03
Study Completion Date2025-10-16

Terms related to this study

Keywords Provided by Researchers

  • syphilis
  • doxycycline

Additional Relevant MeSH Terms

  • Syphilis