Cefixime Clinical Trial

Last updated: February 13, 2025
Sponsor: University of Southern California
Overall Status: Active - Recruiting

Phase

3

Condition

Sexually Transmitted Diseases (Stds)

Hiv/aids

Aids And Aids Related Infections

Treatment

Cefixime 400mg

benzathine penicillin

Clinical Study ID

NCT04958122
HS-21-00288
  • Ages > 18
  • All Genders

Study Summary

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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8within 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 andvirologically suppressed (viral load <200 copies/mL) or have a CD4 count ≥ 350cells/mm3 according to most recent labs before study enrollment

Exclusion

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 activityagainst syphilis, namely azithromycin, doxycycline, ceftriaxone, or otherbeta-lactam antibiotics (e.g. amoxicillin)

  • Individuals with HIV infection who report HIV treatment interruption for more than 4weeks since their most recent viral load or CD4 test

  • Self-reported allergy to cephalosporins or penicillin

  • Unwilling or unable to attend follow-up visits

Study Design

Total Participants: 400
Treatment Group(s): 2
Primary Treatment: Cefixime 400mg
Phase: 3
Study Start date:
June 20, 2021
Estimated Completion Date:
June 30, 2027

Study 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.

Connect with a study center

  • University of Southern California

    Los Angeles, California 90032
    United States

    Active - Recruiting

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