Could a pill replace the shot for syphilis?
NCT ID NCT04958122
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study compares two antibiotics for treating early syphilis: a single penicillin shot (standard care) versus a 14-day course of cefixime pills. Researchers want to see if the pill works just as well. The study includes 400 adults with early syphilis, including those with well-controlled HIV.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 400 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jun 2021
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment * 18 years of age or older * Able to provide informed consent * Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load \<200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment Exclusion Criteria: * Pregnancy or a positive pregnancy test on the day of enrollment * Patients showing signs and symptoms of neurosyphilis * Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater * Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin) * Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test * Self-reported allergy to cephalosporins or penicillin * Unwilling or unable to attend follow-up visits
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Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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University of Southern California
RECRUITINGLos Angeles, California, 90032, United States
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Other studies related to the condition(s) this trial covers.
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- Home test kits could transform STI screening for sex workers
- Could a single shot replace daily HIV pills?