Linezolid for Syphilis Pilot Study
Purpose
The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.
Condition
- Syphilis
Eligibility
- Eligible Ages
- Over 16 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- 16 years of age or older - Diagnosed cases of primary, secondary, or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment - Able to provide informed consent - For PLHIV: on treatment for HIV-infection and most recent viral load <200 copies/mL or most recent CD4 T-cell count >350 cells/mL
Exclusion Criteria
- Pregnancy or a positive pregnancy test on the day of enrollment - Participants who receive certain psychotropic medications, e.g., MAO inhibitors, SNRIs, SSRIs - Patients showing signs and symptoms of neurosyphilis - Serofast RPR titer - Recent (<7 days) or concomitant antimicrobial therapy with azithromycin, doxycycline, ceftriaxone, cefixime, or other beta lactam antibiotics (e.g. amoxicillin) - Linezolid or penicillin allergy
Study Design
- Phase
- Phase 2
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Linezolid 10 Day |
Oral linezolid 600mg, taken twice a day for 10 days |
|
|
Active Comparator Benzathine Penicillin G |
Single intramuscular injection of 2.4 million units of benzathine penicillin G |
|
Recruiting Locations
Chicago, Illinois 60613
Catherine Creticos, MD
More Details
- Status
- Recruiting
- Sponsor
- University of Southern California
Detailed 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.