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Recruiting Phase 3 NCT04958122

Cefixime Clinical Trial

Trial Parameters

Condition Syphilis
Sponsor University of Southern California
Study Type INTERVENTIONAL
Phase Phase 3
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2021-06-20
Completion 2027-01-01
Interventions
Cefixime 400mgbenzathine penicillin

Brief Summary

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

Eligibility 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 sin

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