Comparing Oral Cefixime to Penicillin G Injection for Early Syphilis Treatment Including Patients With and Without HIV Infection

What this Trial Is About

Researchers are evaluating the effectiveness of cefixime compared to benzathine penicillin G in treating early syphilis, including patients with and without HIV infection. This Phase 3, randomized, open-label trial aims to find an alternative treatment option to penicillin, especially useful for those with penicillin allergies or where penicillin shortages exist. The study involves 400 participants recruited from multiple sites in the U.S. and Peru. Participants will be assigned to one of two treatment groups one receiving oral cefixime 400 mg twice daily for 10 days, and the other receiving a single intramuscular injection of 2.4 million units of benzathine penicillin G. The study is designed to compare these treatments over time to assess their effectiveness in managing syphilis. Throughout the study, participants will have follow-up visits every 3 months for 9 months to monitor their clinical progress and serological response through RPR titer measurements. The primary outcome measure is the response to treatment evaluated at 6 months. The study includes ongoing assessments to ensure participant safety and adherence to treatment protocols.

Cefixime Clinical Trial