Daily doxycycline treatment for early syphilis
Daily Doxycycline for Early Syphillis
This study is testing if taking a daily pill of doxycycline for 14 days can effectively treat early syphilis in a small group of 15 people.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University of Washington Academic / other |
| Locations | 1 site (Seattle, Washington) |
| Trial ID | NCT06683638 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate the effectiveness of a daily dose of 200mg doxycycline taken for 14 days in treating early stage syphilis. Unlike the traditional twice-daily regimen, this study investigates the potential of a single daily dose based on lab data suggesting it may be effective. Participants will undergo regular testing and surveys to assess clinical improvement and blood test results over a six-month period. The study will include a small cohort of 15 participants diagnosed with early syphilis.
Who should consider this trial
Good fit: Ideal candidates include individuals aged 18 and older with a clinical diagnosis of primary or secondary syphilis or laboratory-confirmed early latent syphilis.
Not a fit: Patients with neurosyphilis, tertiary syphilis, or those unable to provide informed consent may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a more convenient and effective option for patients with early syphilis.
How similar studies have performed: While this approach of a single daily dose has not been extensively studied, it is based on promising lab data, making it a novel investigation.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 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: 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). Exclusion Criteria: 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 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 discontinue doxycycline 200mg once daily. Their subsequent treatment will be based on the judgement of non-research, clinical staff in the clinic and reflect shared decision making between clinical providers and their patient.
Where this trial is running
Seattle, Washington
- Public Health Sexual Health Clinic — Seattle, Washington, United States (Recruiting)
Study contacts
- Principal investigator: Travis Hunt, MD — University of Washington
- Study coordinator: Travis Hunt, MD
- Email: thunt91@uw.edu
- Phone: 206-685-4456
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.