Abstract
BackgroundSyphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Currently, benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. 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-treatment 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.gov NCT03660488. Registered on 4 September 2018.
Highlights
Background and rationale {6a} Syphilis rates have been increasing both in the USA and internationally
Half of the new early cases of syphilis occur among men-who-have-sexwith-men, while incidence is high among and people living with human immunodeficiency virus (HIV) infection
Benzathine penicillin is the recommended treatment for syphilis in all patients, including those living with HIV infection
Summary
Background and rationale {6a} Syphilis rates have been increasing both in the USA and internationally. Between 2013 and 2017, the rate of syphilis cases in the USA increased from 17.9 cases per 100,000 (56,485 reported cases) to 31.2 cases per 100, 000 (101,584 reported cases). Half of the new early cases of syphilis occur among men-who-have-sexwith-men, while incidence is high among and people living with human immunodeficiency virus (HIV) infection. Benzathine penicillin is the recommended treatment for syphilis in all patients, including those living with HIV infection. Syphilis rates have been increasing both in the USA and internationally with incidence higher among men-who-have-sex-with-men and people living with human immunodeficiency virus (HIV) infection. Benzathine penicillin is the recommended treatment for syphilis in all patients. Global shortages and cost increases in benzathine penicillin call for alternative treatment options. This study evaluates the efficacy of oral cefixime for the treatment of early syphilis
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