Cefixime Clinical Trial

Human Immunodeficiency Virus Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04958122
• Other study ID #: HS-21-00288
• Status: Recruiting
• Phase: Phase 3
• Start date: June 20, 2021
• Est. completion date: June 30, 2025

Study information

• Verified date: June 2024
• Source: University of Southern California
• Contact: Jeffrey D Klausner
• Phone: (415) 876-8901
• Email: jdklausner[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 30, 2025
• Est. primary completion date: January 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acquired Immunodeficiency Syndrome
• HIV Infections
• Human Immunodeficiency Virus
• Syphilis

Intervention

Drug:
• Cefixime 400mg
Oral cefixime 400 mg, one capsule, twice a day for 10 days
• benzathine penicillin
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Locations

Country	Name	City	State
United States	University of Southern California	Los Angeles	California

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	AIDS Healthcare Foundation, Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Response to treatment	Percentage of cefixime participants with a 4-fold decrease or greater in the serum RPR titer 3 or 6 months after treatment completion	6 months