Cefixime for Alternative Syphilis Treatment

Summary

The goal of the study is to evaluate the efficacy of oral cefixime as an alternative treatment for syphilis infection. One hundred adult patients (≥18 years old) with syphilis infection (positive Treponema Pallidum Particle Agglutination assay and RPR titer ≥ 1/8) will be recruited. Participants will be randomized (1:1) to receive either the standard of care Penicillin or Cefixime. During the study, participants will visit the clinic up to 5 times; at baseline visit, at 3, 6, 12 months after treatment initiation. Participants of the cefixime group will be required to visit the clinic 14 days after treatment initiation. In each visit, participants will be asked about current symptoms and do laboratory tests for syphilis (RPR). Subjects who have a 4-fold decrease (from study entry RPR) in RPR titers from baseline at 6 months will be considered a positive treatment response.

Timeline

Start

2018-09-03

Primary completion

2021-01-30

Completion

2021-01-30

Publications

• Mehta SN, Stafylis C, Tellalian DM, Burian PL, Okada CM, Millner CE, Mejia CM, Klausner JD. Clinical trial protocol to evaluate the efficacy of cefixime in the treatment of early syphilis. Trials. 2020 Dec 9;21(1):1009. doi: 10.1186/s13063-020-04885-z.

Drugs

Indications