Actively Recruiting
Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis
Led by University of Southern California · Updated on 2026-05-04
400
Participants Needed
1
Research Sites
25 weeks
Total Duration
On this page
Sponsors
U
University of Southern California
Lead Sponsor
A
AIDS Healthcare Foundation
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness of cefixime compared to benzathine penicillin G in treating early syphilis, including patients with and without HIV infection. This Phase 3, randomized, open-label trial aims to find an alternative treatment option to penicillin, especially useful for those with penicillin allergies or where penicillin shortages exist. The study involves 400 participants recruited from multiple sites in the U.S. and Peru. Participants will be assigned to one of two treatment groups: one receiving oral cefixime 400 mg twice daily for 10 days, and the other receiving a single intramuscular injection of 2.4 million units of benzathine penicillin G. The study is designed to compare these treatments over time to assess their effectiveness in managing syphilis. Throughout the study, participants will have follow-up visits every 3 months for 9 months to monitor their clinical progress and serological response through RPR titer measurements. The primary outcome measure is the response to treatment evaluated at 6 months. The study includes ongoing assessments to ensure participant safety and adherence to treatment protocols.
CONDITIONS
Brief Title
Cefixime Clinical Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with 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
- For individuals with HIV infection: must be on HIV treatment and virologically suppressed (viral load <200 copies/mL) or have a CD4 count 350 cells/mm3 based on recent labs
You will not qualify if you...
- Pregnant or positive pregnancy test at enrollment
- Signs or symptoms of neurosyphilis
- Serofast RPR titer with no more than 4-fold change for 12 months or longer
- Recent or current use of antibiotics active against syphilis (e.g., azithromycin, doxycycline, ceftriaxone, beta-lactams) within past 7 days
- HIV patients with treatment interruption longer than 4 weeks since last viral load or CD4 test
- Allergy to cephalosporins or penicillin
- Unwilling or unable to attend follow-up visits
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 10 days
Participants receive either oral cefixime 400 mg twice daily for 10 days or a single intramuscular injection of benzathine penicillin G.
1 baseline visit (in-person)
Duration - 9 months
Participants attend follow-up visits every 3 months for 9 months to monitor clinical outcomes and serological response.
Follow-up visits every 3 months for 9 months
Trial Site Locations
Total: 1 location
1
University of Southern California
Los Angeles, California, United States, 90032
Actively Recruiting
Research Team
J
Jeffrey D Klausner
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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