Cefixime Clinical Trial

ConditionsSyphilis Human Immunodeficiency Virus

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

This trial does not accept healthy volunteers

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

Design model

Parallel

Treatments tested in this trial

Cefixime 400mg
Drug
Oral cefixime 400 mg, one capsule, twice a day for 10 days
benzathine penicillin
Drug
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: CefiximeExperimental treatment 1 intervention

Group B: Benzathine Penicillin GActive comparator 1 intervention

Trial outcomes

Primary outcomes

Response to treatment

Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion

Time frame

6 months

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Southern California

Lead sponsor

AIDS Healthcare Foundation

Collaborator

Universidad Peruana Cayetano Heredia

Collaborator

Source ClinicalTrials.gov

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