Evaluating cefixime for treating syphilis

Clinical Trial Comparing the Effectiveness of Cefixime Versus Penicillin G for Treatment of Early Syphilis

This study is testing if cefixime can effectively treat early syphilis in patients, including those with HIV, as an alternative to the standard penicillin treatment.

Quick facts

• Phase: PHASE3
• Study type: Interventional
• Enrollment: 400 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Southern California (other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT04958122 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include adults aged 18 and older diagnosed with primary, secondary, or early latent syphilis and who are either HIV-positive and virologically suppressed or HIV-negative.

Not a fit: Patients who are pregnant, have signs of neurosyphilis, or have recently received other antimicrobial therapies for syphilis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide an effective alternative treatment for syphilis, especially for patients with penicillin allergies or those living with HIV.

How similar studies have performed: Other studies have explored alternative treatments for syphilis, but this specific comparison of cefixime to benzathine penicillin G is novel.

Eligibility criteria

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 this trial is running

Los Angeles, California

• 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

Conditions: Syphilis, Human Immunodeficiency Virus, Cefixime, Treponema pallidum, Penicillin, Early Syphilis