University of Southern California
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.
This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatmen…
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…
Oral cefixime 400 mg, one capsule, twice a day for 10 days
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
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