At a glance
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Clinical Trial Evaluating the Clinical Efficacy of Cefixime for Treatment of Early Syphilis
In Brief
A Phase 2 clinical trial evaluating Cefixime 400 milligram Oral Capsule [Suprax] and Benzathine Penicillin G for Syphilis and Early Syphilis. Completed, enrolled 58 participants across 10 sites.
Detailed 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.
Study Details
Timeline
Interventions
The intervention group will receive Cefixime 400mg, one tablet twice per day, for ten consecutive days
The control group will receive Benzathine Penicillin G 2.4 Million Units intramuscularly for treatment of syphilis. Penicillin is the indicated treatment for syphilis infection