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Cefixime Clinical Trial

NCT04958122

RecruitingPhase 3

Sponsor: University of Southern California

Conditions: Syphilis, Human Immunodeficiency Virus

Interventions: Cefixime 400mg, benzathine penicillin

Countries: United States

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

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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 since their most recent viral load or CD4 test
* Self-reported allergy to cephalosporins or penicillin
* Unwilling or unable to attend follow-up visits

Locations (1)

Los Angeles, California, United States