Cefixime Clinical Trial

Recruiting · NCT04958122 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Southern California

Interventions studied

Cefixime 400mgbenzathine penicillin

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

Age range

18 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Phase 3

Study type

Interventional (participants receive a specific treatment)

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

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

1 location listed across 1 US state.