NCT05548426

Linezolid for Syphilis Pilot Study

Pilot Study of Linezolid for Early Syphilis Treatment

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (estimated)
• Sponsor: University of Southern California · Academic / Other
• Sex: All
• Age: 16 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This will be a randomized, open-label, non-comparative, pilot trial to evaluate the efficacy of linezolid 600mg orally, twice a day, for 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. A 5 and 10-day phone call will ensure adherence to treatment and evaluate safety. 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.

Conditions

• Syphilis

Interventions

Type	Name	Description
DRUG	Group B, Linezolid 10d	Oral Linezolid 600mg, taken twice a day for 10 days
DRUG	Group A, Penicillin	Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Timeline

• Start date: 2023-09-28
• Primary completion: 2026-08-01
• Completion: 2026-08-01
• First posted: 2022-09-21
• Last updated: 2026-03-12

Locations

5 sites across 1 country: United States

Regulatory

• FDA-regulated drug study