Linezolid for Syphilis Pilot Study

University of Southern California

Status and phase: Enrolling; Phase 2

Conditions: Syphilis

Treatments: Drug: Group B, Linezolid 10d; Drug: Group A, Penicillin

Study type: Interventional

Funder types: Other

Identifiers

NCT05548426

APP-22-04165

Details and patient eligibility

About

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

Full 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.

Enrollment: 24 estimated patients

Sex: All

Ages: 16+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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24 participants in 2 patient groups

Linezolid 10 Day

Experimental group

Description:

Oral linezolid 600mg, taken twice a day for 10 days

Treatment:

Drug: Group B, Linezolid 10d

Benzathine Penicillin G

Active Comparator group

Description:

Single intramuscular injection of 2.4 million units of benzathine penicillin G

Treatment:

Drug: Group A, Penicillin