Cefixime Clinical Trial
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Southern California
About this trial
This study aims to evaluate the efficacy of cefixime compared to benzathine penicillin G in the treatment of syphilis.
Eligibility criteria
Qualifiers
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
Disqualifiers
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)
Trial design
Treatments tested in this trial
- Cefixime 400mg
- benzathine penicillin
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Southern California
Lead sponsor
AIDS Healthcare Foundation
Collaborator
Universidad Peruana Cayetano Heredia
Collaborator
Source ClinicalTrials.gov