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Tetracycline Antibiotic

Doxycycline 200mg daily for 14 days for Syphilis

Phase 2
Waitlist Available
Led By Travis Hunt, MD
Research Sponsored by University of Washington
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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).
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
No Placebo-Only Group

Summary

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.

Who is the study for?
This trial is for individuals with early stage syphilis. Participants will take a daily dose of doxycycline, submit swabs every other day for two weeks, complete online surveys, and attend up to three clinic visits over six months. Specific eligibility criteria are not provided.
What is being tested?
The study tests if taking doxycycline as a single daily dose of 200mg for 14 days can effectively treat early syphilis. It compares this method's effectiveness based on clinical improvement and blood test results against standard treatments recorded from the sexual health program.
What are the potential side effects?
Potential side effects of doxycycline may include nausea, diarrhea, sun sensitivity, rash or allergic reactions. The exact side effects experienced by participants in this specific dosage regimen will be monitored throughout the trial.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Composite clinical and serological response

Side effects data

From 2022 Phase 4 trial • 449 Patients • NCT04050540
3%
Malaria
100%
80%
60%
40%
20%
0%
Study treatment Arm
Standard of Care Arm
dPEP Intervention Arm

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Doxycycline 200mg daily for 14 daysExperimental Treatment1 Intervention
Participants diagnosed with early syphilis (primary, secondary, or early latent) with an RPR of 1:4 or greater will receive doxycycline 200mg daily to treat syphilis. Exclusions include pregnant persons, persons under 18 years of age, and persons on doxy PEP. During the two weeks of treatment, participants will perform oral and rectal swabs for syphilis, returned at the end of the 2 weeks by mail. Participants will submit brief online surveys twice over the two weeks of treatment. Repeat blood tests for syphilis, reactive plasma reagin (RPR), will be done at follow-up visits at 3 and 6 months to monitor serological response. Participants with response at the 3-month visit will not need to come to a 6-month visit.

Find a Location

Who is running the clinical trial?

University of WashingtonLead Sponsor
1,815 Previous Clinical Trials
1,913,033 Total Patients Enrolled
5 Trials studying Syphilis
4,271 Patients Enrolled for Syphilis
Travis Hunt, MDPrincipal InvestigatorUniversity of Washington
~10 spots leftby Jun 2025