Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis

This study evaluates the efficacy of oral cefixime for the treatment of early syphilis.MethodsWe are conducting a randomized, multisite, open-label, non-comparative clinical trial in Los Angeles and Oakland, CA. Eligible participants are ≥ 18 years old, with primary, secondary, or early latent syphilis (rapid plasma reagin [RPR] titer ≥ 1:8). Patients with HIV infection must have a viral load≤ 200 copies/mL and CD4+ T cell count ≥ 350 cells/μL during the past 6 months. Participants are randomized to receive either 2.4 M IU benzathine penicillin G intramuscularly once or cefixime 400 mg orally twice a day for 10 days. Participants return at 3, 6, and 12 months post-tr eatment for follow-up RPR serological testing. The primary outcome is the proportion of participants who achieve ≥ 4-fold RPR titer decrease at 3 or 6 months post-treatment.DiscussionClinical trials evaluating the efficacy of alternative antibiotics to penicillin are urgently needed.Trial registrationClinicaltrials.govNCT03660488. Registered on 4 September 2018.
Source: Trials - Category: Research Source Type: clinical trials