Cefixime Clinical Trial

  • STATUS
    Recruiting
  • End date
    Jun 26, 2025
  • participants needed
    400
  • sponsor
    University of Southern California
Updated on 26 July 2021
HIV Vaccine

Summary

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

Description

This will be a randomized, multisite, open-label, non-inferiority clinical trial to evaluate the effectiveness of cefixime (400mg orally, twice a day, for 10 days) compared to benzathine penicillin G (2.4 million units, intramuscularly) in patients with and without HIV infection. In total, 400 participants with early syphilis will be enrolled from 9 clinical sites in the U.S. and Peru. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) every 3 months for 9 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin, effective for people living with HIV infection, to help address the crisis of penicillin shortages and offer options for those with penicillin allergy.

Details
Condition HIV, HIV infection, Syphilis, HIV Infections, human immunodeficiency virus, hiv disease
Treatment benzathine penicillin, Cefixime 400mg
Clinical Study IdentifierNCT04958122
SponsorUniversity of Southern California
Last Modified on26 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer 1:8 within 3 weeks prior to enrollment
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
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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