Linezolid for Syphilis Pilot Study

Study Overview
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Brief Summary
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The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.

Detailed Description
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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.

Official Title
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Pilot Study of Linezolid for Early Syphilis Treatment

Conditions
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Syphilis

Intervention / Treatment
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* Drug: Group B, Linezolid 10d
* Drug: Group A, Penicillin


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Linezolid 10 Day<br>Oral linezolid 600mg, taken twice a day for 10 days | Drug: Group B, Linezolid 10d<br>* Oral Linezolid 600mg, taken twice a day for 10 days<br>* Other names: zyvox;|
| Active Comparator: Benzathine Penicillin G<br>Single intramuscular injection of 2.4 million units of benzathine penicillin G | Drug: Group A, Penicillin<br>* Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU<br>* Other names: bicillin;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Response to Treatment | Percentage of linezolid participants with a 4-fold decrease or greater in the serum RPR titer by 180 days after treatment | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Linezolid, Treponema pallidum, Penicillin, Early Syphilis