NCT Number: NCT06683638
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 2
Seattle, Washington, 98104, United States
Location status: Recruiting
Jakar Delacruz
CONTACT
Matthew R Golden, MD, MPH
PRINCIPAL_INVESTIGATOR
Travis Hunt, MD
CONTACT
Travis J Hunt, MD
PRINCIPAL_INVESTIGATOR
This is an open-label prospective cohort of 15 participants diagnosed with early syphilis treated with doxycycline 200mg daily for 14 days. The outcome of interest is clinical improvement and fourfold decline in RPR by 6 months. This study will include rectal and oropharyngeal sampling with syphilis transcription-mediated amplification (TMA), every other day for the 14-day course, returned by mail. The investigators will obtain 6-month point estimates for cure following single-dose intramuscular benzathine penicillin G or 14 days of doxycycline 100mg twice daily in retrospective cohorts of 60 persons. The investigators will use binomial exact calculation with an alpha of 0.05, two-tailed, to create a point estimates of percent cure. The investigators will report TMA positivity descriptively.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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:
Exclusion criteria
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.
Doxycycline will be taken as a single dose of 200mg daily, rather than the current CDC-recommended 100mg twice daily regimen for early syphilis. The duration will still be 14 days of therapy.
Time frame: 6 months
Clinical response and serological response will be aggregated to arrive at one reported value, a binary outcome of "yes" (1) or "no" (0).
Clinical response equates to resolution of clinical symptoms of syphilis the participants presented with, such as rash or chancre, without the development of new symptoms of syphilis. Resolution will be marked as "yes" or "no".
Serological response equates to a fourfold decrease in RPR compared to the presenting RPR titer by 6 months. Resolution will be marked as "yes" or "no".
Thus, to generate the composite response outcome, participants with outcomes of "yes" for both clinical response and serological response will qualify as a binary outcome of "yes" (1) . Participants who do not have outcomes of "yes" for both clinical response and serological response will qualify as a binary outcome of "no" (0).
Contact information is provided by the study sponsor or research team.
Matthew Golden, MD, MPH
CONTACT
Travis Hunt, MD
CONTACT
University of Washington
Other
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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