Active — Not RecruitingPhase 2

Linezolid for Syphilis Pilot Study

United States24 participantsStarted 2023-09-28

Plain-language summary

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

Age range16 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

✓. Diagnosed cases of primary, secondary or early latent syphilis with RPR titer ≥1:8 within 3 weeks prior to enrollment
✓. 16 years of age or older
✓. Able to provide informed consent/assent.
✓. Individuals with HIV infection must be on treatment for HIV-infection and virologically suppressed (viral load \< 200 copies/mL) or have a CD4 count ≥ 350 cells/mm3 as of their most recent test prior to enrollment.

✕. Pregnancy or a positive pregnancy test on the day of enrollment
✕. Patients showing signs and symptoms of neurosyphilis.
✕. Participants who receive certain psychotropic medications, e.g., MAO inhibitors, SNRIs, SSRIs
✕. Serofast RPR titer, defined as persistently positive RPR titer without more than 4-fold (2-titer level) change for 12 months or greater.
✕. Recent (within the past 7 days) or concomitant antimicrobial therapy with activity against syphilis, namely azithromycin, tetracycline, doxycycline, cefixime, ceftriaxone or other beta lactam antibiotics (e.g. amoxicillin)
✕. Individuals with HIV infection who report HIV treatment interruption for more than 4 weeks since their most recent viral load or CD4 test.
✕. Individuals with known myelosuppressive conditions or receiving myelosuppressive medication
✕. Individuals weighing 150kg (330 lbs) or more.

Response to Treatment

Timeframe: 6 months

NCT IDNCT05548426

SponsorUniversity of Southern California

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-08