Linezolid for Syphilis Pilot Study

Syphilis Clinical Trial

Official title:

Pilot Study of Linezolid for Early Syphilis Treatment

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05548426
• Other study ID #: APP-22-04165
• Status: Recruiting
• Phase: Phase 2
• Start date: September 28, 2023
• Est. completion date: March 2025

Study information

• Verified date: December 2023
• Source: University of Southern California
• Contact: Jeffrey D Klausner, MD MPH
• Phone: (415) 876-8901
• Email: jdklausner[@]med.usc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: March 2025
• Est. primary completion date: March 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 16 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Syphilis

Intervention

Drug:
• Group B, Linezolid 10d
Oral Linezolid 600mg, taken twice a day for 10 days
• Group A, Penicillin
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU

Locations

Country	Name	City	State
United States	Howard Brown Health	Chicago	Illinois
United States	Open Arms HealthCare Center	Jackson	Mississippi

Sponsors (3)

Lead Sponsor	Collaborator
University of Southern California	The University of Texas Health Science Center, Houston, Universidad Peruana Cayetano Heredia

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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