Cefixime Clinical Trial

Status Recruiting

Clinical Trial Summary

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

Clinical Trial 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 Design

Related Conditions & MeSH terms

Acquired Immunodeficiency Syndrome
HIV Infections
Human Immunodeficiency Virus
Syphilis

Clinical Trial Details

NCT number	NCT04958122
Study type	Interventional
Source	University of Southern California
Contact	Jeffrey D Klausner
Phone	(415) 876-8901
Email	jdklausner@med.usc.edu
Status	Recruiting
Phase	Phase 3
Start date	June 20, 2021
Completion date	March 1, 2025

View Details

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