Cefixime Clinical Trial

Phase 3

Recruiting

• Conditions: Syphilis; Human Immunodeficiency Virus
• Interventions: Drug: Cefixime 400mg; Drug: benzathine penicillin

• Registration Number: NCT04958122
• Lead Sponsor: University of Southern California

Brief Summary

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

Detailed 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.

Study Timeline

• Study Start: 2021-06-20
• Study First Submitted: 2021-06-29
• Study First Submitted QC: 2021-06-29
• Study First Posted: 2021-07-12
• Status Verified: 2025-02
• Last Update Submitted: 2025-02-13
• Last Update Posted: 2025-02-17
• Primary Completion: 2027-01-01
• Study Completion: 2027-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cefixime	Cefixime 400mg	Oral cefixime 400mg, taken twice a day for 10 days
Benzathine Penicillin G	benzathine penicillin	Single intramuscular injection of 2.4 million units of benzathine penicillin G

Primary Outcome Measures

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

Trial Locations

Locations (1)

University of Southern California; 🇺🇸 Los Angeles, California, United States