Evaluating cefixime for treating syphilis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial aims to assess the effectiveness of cefixime compared to benzathine penicillin G in treating early syphilis in patients, including those with HIV. It is a randomized, multisite, open-label, non-inferiority trial involving 400 participants who will receive either cefixime (400mg orally, twice daily for 10 days) or benzathine penicillin G (2.4 million units intramuscularly). Participants will be monitored for clinical outcomes and serological responses every three months for nine months. The study seeks to identify a viable alternative treatment for syphilis, particularly for individuals with penicillin allergies or in light of penicillin shortages.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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

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

Where it's running

• University of Southern California
  Los Angeles, California, United States Recruiting

Study contacts

• Principal investigator: Jeffrey D Klausner, MD MPH — University of Southern California
• Study coordinator: Jeffrey D Klausner
• Email: jdklausner@med.usc.edu
• Phone: (415) 876-8901

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.