Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE2
24 participants
INTERVENTIONAL
2023-09-28
2026-03-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Linezolid 10 Day
Oral linezolid 600mg, taken twice a day for 10 days
Group B, Linezolid 10d
Oral Linezolid 600mg, taken twice a day for 10 days
Benzathine Penicillin G
Single intramuscular injection of 2.4 million units of benzathine penicillin G
Group A, Penicillin
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
Interventions
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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
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
16 Years
ALL
No
Sponsors
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Universidad Peruana Cayetano Heredia
OTHER
The University of Texas Health Science Center, Houston
OTHER
University of Southern California
OTHER
Responsible Party
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Jeffrey D Klausner
Clinical Professor
Principal Investigators
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Jeffrey D Klausner, MD MPH
Role: PRINCIPAL_INVESTIGATOR
University of Southern California
Locations
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Howard Brown Health
Chicago, Illinois, United States
Open Arms HealthCare Center
Jackson, Mississippi, United States
Countries
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Central Contacts
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Facility Contacts
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Catherine Creticos, MD
Role: primary
Keith Stokes, MD
Role: primary
Other Identifiers
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APP-22-04165
Identifier Type: -
Identifier Source: org_study_id
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