Cefixime for Syphilis Treatment Study

This study is testing if cefixime (an oral medication) works as well as benzathine penicillin G (an injection) for treating syphilis. Researchers want to find another effective treatment, especially for people with HIV, to help with penicillin shortages and offer options for those with penicillin allergies. You might be able to join if you are 18 or older and have primary, secondary, or early latent syphilis with a specific blood test result (RPR titer ≥1:8). If you have HIV, you must be on treatment and have a low viral load or a CD4 count ≥ 350. The study will look at how well the treatments work after 6 months. The current recruitment status is unclear, but the study plans to enroll 400 participants.

Study design
This is a randomized, multisite, open-label study comparing two treatments. It plans to enroll 400 participants.
What's involved
You would take cefixime twice a day for 10 days or receive one injection of benzathine penicillin G. You will have follow-up visits every 3 months for 9 months to check your progress.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 9 months after treatment to monitor clinical outcomes and serological response.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT04958122

Cefixime Clinical Trial

Recruiting
PHASE3Ages 18+InterventionalTreatment
University of Southern California
~400 participants
Updated 2026-05-04 on ClinicalTrials.gov
What's tested:Cefixime 400mgbenzathine penicillin

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Response to treatment
Measured over 6 months
Syphilis
Human Immunodeficiency Virus
1 sites across 1 states
California1
  • Jeffrey D Klausner, MD MPH · PRINCIPAL_INVESTIGATOR · University of Southern California

Opens a ready-to-send draft in your own email app — review before sending.

Do you actually qualify for this trial?

Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.

Check eligibility for this trial ~2 min · HIPAA-protected · delete anytime
Eligibility criteria

Inclusion

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

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
  • Response to treatment6 months

    Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion