Linezolid for Syphilis Pilot Study

Status Recruiting

Clinical Trial Summary

The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.

Clinical Trial Description

This will be a randomized, open-label, non-comparative, adaptive pilot trial to evaluate the efficacy of linezolid 600mg orally, twice a day, for five or ten days, using a contemporaneous historical control group benzathine penicillin G (single dose of 2.4 million units) in participants with and without HIV infection. In total, 24 participants will be enrolled across multiple clinical sites in the United States. Participants will participate in follow-ups to monitor clinical outcomes and serological response (RPR titer) at 1 month, 3 months, and 6 months. Study findings may identify an efficacious alternative syphilis treatment to penicillin that is effective for people living with HIV. Study findings may also help address the crisis of penicillin shortages, difficulty in administration, and offer options for those with penicillin allergy. ;

Study Design

Related Conditions & MeSH terms

Syphilis

Clinical Trial Details

NCT number	NCT05548426
Study type	Interventional
Source	University of Southern California
Contact	Jeffrey D Klausner, MD MPH
Phone	(415) 876-8901
Email	jdklausner@med.usc.edu
Status	Recruiting
Phase	Phase 2
Start date	September 28, 2023
Completion date	March 2025

View Details

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