Linezolid Pilot Study

• Status: Not yet recruiting
• Trial end date: 2025-03-01
• Target enrollment: 0
• Participant gender: All

Summary

The two specific aims are: AIM 1: To evaluate the efficacy of linezolid compared to benzathine penicillin G in the treatment of syphilis. AIM 2: Evaluate the susceptibility of Treponema pallidum historical and novel strains to linezolid.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Southern California
• Collaborators: The University of Texas Health Science Center, Houston; Universidad Peruana Cayetano Heredia
• Treatments: Linezolid; Penicillins

Criteria

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