Clinical Trial

Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis.

Study acronym: AMOXSYP
Active, Not Recruiting Phase 3
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Summary
The goal of this clinical trial is to learn if oral amoxicillin has comparable therapeutic response than penicillin G benzathine for the treatment of acquired pediatric syphilis. It will also learn about the adverse events and biomarkers of therapeutic response associated with oral amoxicillin. The main questions it aims to answer are: * Does comparable therapeutic response oral amoxicillin to penicillin G benzathine in the treatment of acquired pediatric syphilis? * Does adequate serologic response to treatment participants with syphilis when taking oral amoxicillin? Researchers will compare oral amoxicillin to intramuscular procaine benzathine penicillin to see if oral amoxicillin works similar to treat acquired pediatric syphilis. Participants will: * Take 40-50mg/kg oral amoxicillin every day for 14 to 21 days or an intramuscular procaine benzathine penicillin injection at a dose of 50,000 IU/kg per week for one to three weeks. * Follow-up visits every two months after treatment until a one-year follow-up is completed. * Keep a diary of their symptoms and the number of times they take the medications
Trial Details
NCT Number NCT06877351
Lead Sponsor Hospital de Niños R. Gutierrez de Buenos Aires
Conditions Syphilis Acquired
Enrollment 120 participants
Start Date 2024-08-14
Primary Completion 2027-01-01 (estimated)
Study Completion 2027-06-01 (estimated)
Updated on ClinicalTrials.gov 2025-03-14