Actively Recruiting

Phase 2
Age: 18Years +
All Genders
NCT06683638

Daily Doxycycline for Early Syphillis

Led by University of Washington · Updated on 2025-06-25

15

Participants Needed

1

Research Sites

68 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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

Official Title

Daily Doxycycline for Early Syphillis

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of primary or secondary syphilis or laboratory-confirmed early latent syphilis within the past 31 days
  • Clinical diagnosis of primary syphilis with a positive qualitative RPR or positive darkfield microscope exam from a chancre
  • Clinical diagnosis of secondary syphilis with a positive qualitative RPR
  • Laboratory-confirmed early latent syphilis within one month prior to enrollment
  • Age 18 years or older
Not Eligible

You will not qualify if you...

  • Age under 18 years
  • Evidence of neurosyphilis (including ocular and otic syphilis) or tertiary syphilis
  • Unable to give informed consent
  • Unable to complete study follow-up visits
  • Allergy to doxycycline
  • Pregnant persons
  • Persons with HIV who are off antiretroviral medication or not virologically suppressed
  • Other known immunosuppression (e.g., systemic immunosuppressant drugs, primary immunodeficiencies)
  • Taking medications that interact with doxycycline
  • Initial RPR lower than 1:4
  • Currently prescribed doxycycline post-exposure prophylaxis (PEP)
  • Breastfeeding persons

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Public Health Sexual Health Clinic

Seattle, Washington, United States, 98104

Actively Recruiting

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Research Team

T

Travis Hunt, MD

CONTACT

M

Matthew Golden, MD, MPH

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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