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

HS-21-00288

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

2021-06-20

2024-07-01

2025-03-01

Recruiting

Early phase I

400

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

{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE3'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 400, 'type': 'ESTIMATED'}}

2023-12-14