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Clinical trial

Pilot Study of Linezolid for Early Syphilis Treatment

ID
Name
APP-22-04165
Description
The study aims to evaluate the efficacy of linezolid for the treatment of syphilis.
Trial arms
Trial start
2023-09-28
Estimated PCD
2025-03-01
Trial end
2025-03-01
Status
Recruiting
Phase
Early phase I
Treatment
Group B, Linezolid 10d
Oral Linezolid 600mg, taken twice a day for 10 days
Arms:
Linezolid 10 Day
Other names:
zyvox
Group A, Penicillin
Standard of care benzathine penicillin G, one intramuscular injection, 2.4MU
Arms:
Benzathine Penicillin G
Other names:
bicillin
Size
24
Primary endpoint
Response to Treatment
6 months
Eligibility 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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE2'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 24, 'type': 'ESTIMATED'}}
Updated at
2023-12-14

1 organization

2 products

1 indication

Organization
University of Southern California
Product
Linezolid
Indication
Syphilis
Product
Penicillin