NCT04958122

Cefixime Clinical Trial

Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.

Detailed description

This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.

Conditions

• Syphilis
• Human Immunodeficiency Virus

Interventions

Type	Name	Description
DRUG	Cefixime 400mg	Oral cefixime 400 mg, one capsule, twice a day for 10 days
DRUG	benzathine penicillin	Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Timeline

• Start date: 2021-06-20
• Primary completion: 2027-01-01
• Completion: 2027-06-30
• First posted: 2021-07-12
• Last updated: 2025-02-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study