Linezolid for Syphilis Pilot Study

Phase 2RecruitingNCT05548426

University of Southern California24 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Syphilis

Interventions

Group B, Linezolid 10dDRUG

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

Group A, PenicillinDRUG

Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Eligibility

Sex: ALLMin age: 16 Years

Medical Language ↔ Plain English

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

Locations (2)

Howard Brown Health

Chicago, Illinois, United States

RECRUITING

Open Arms HealthCare Center

Jackson, Mississippi, United States

RECRUITING

Outcomes

Primary Outcomes

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

Central Contacts

Jeffrey D Klausner, MD MPH

CONTACT

(415) 876-8901 jdklausner@med.usc.edu

Data from ClinicalTrials.gov

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