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Tetracycline Antibiotic

Doxycycline 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

Clinical diagnosis of syphilis (primary or secondary) or laboratory-confirmed early latent syphilis

Clinical diagnosis of secondary syphilis with a positive qualitative RPR

Must not have

Other forms of immunosuppression

Medications that interact with doxycycline

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months

Awards & highlights

No Placebo-Only Group

Summary

"This trial aims to see if taking 200mg of doxycycline daily for 14 days in a single dose is effective in treating early stage syphilis. Participants will take the medication

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

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I have been diagnosed with syphilis.

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I have been diagnosed with secondary syphilis confirmed by a positive RPR test.

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I have been diagnosed with primary syphilis confirmed by a test.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not on any form of immunosuppression.

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I am taking medication that interacts with doxycycline.

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I do not have advanced stages of syphilis affecting my nervous system.

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I cannot attend all required study follow-up visits.

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I am currently taking doxycycline as a preventive treatment.

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I am under 18 years old.

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I am unable to understand and agree to the study's procedures and risks.

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I am HIV positive and not on antiretroviral medication or my HIV is not under control.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months

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

Malaria

100%

80%

60%

40%

20%

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.

0 / 11Eligibility criteria met