The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
24
Oral Linezolid 600mg, taken twice a day for 10 days
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
Howard Brown Health
Chicago, Illinois, United States
Open Arms HealthCare Center
Jackson, Mississippi, United States
University of Mississippi Medical Center
Jackson, Mississippi, United States
Wake Forest Baptist Health
Greensboro, North Carolina, United States
Response to Treatment
Percentage of linezolid participants with a 4-fold decrease or greater in the serum RPR titer by 180 days after treatment
Time frame: 6 months
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Open Door Health
Providence, Rhode Island, United States