Cefixime Clinical Trial

• Status: Recruiting
• Trial end date: 2025-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborators: AIDS Healthcare Foundation; Universidad Peruana Cayetano Heredia
• Treatments: Cefixime; Penicillin G; Penicillin G Benzathine; Penicillin G Procaine; Penicillins

Criteria

Inclusion Criteria:

• Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment

• 18 years of age or older

• Able to provide informed consent

• Individuals with HIV infection must be on treatment for HIV infection and virologically suppressed (viral load <200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 according to most recent labs before study enrollment

Exclusion Criteria:

• Pregnancy or a positive pregnancy test on the day of enrollment

• Patients showing signs and symptoms of neurosyphilis

• Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater

• Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, doxycycline, ceftriaxone, or other beta-lactam antibiotics (e.g. amoxicillin)

• Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test

• Self-reported allergy to cephalosporins or penicillin

• Unwilling or unable to attend follow-up visits