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ACTIVE NOT RECRUITING
NCT06877351
PHASE3

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

Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

View on ClinicalTrials.gov

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

Official title: Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis in Pediatric Population: Prospective, Open-label, Non-inferiority, Multicenter Trial

Key Details

Gender

All

Age Range

Any - 18 Years

Study Type

INTERVENTIONAL

Enrollment

120

Start Date

2024-08-14

Completion Date

2027-06-01

Last Updated

2025-03-14

Healthy Volunteers

No

Interventions

DRUG

Amoxicillin

Participants randomized to the intervention group will receive oral amoxicillin at a dose of 40-50 mg/kg/day (maximum 1500 mg/day), administered in three doses daily for 14 days for early syphilis and 21 days for late syphilis or syphilis of unknown duration.

DRUG

Penicillin G, Benzathine

Participants randomized to the control group will receive intramuscular procaine benzathine penicillin (PGB) at a dose of 50,000 IU/kg (maximum 2,400,000 IU/day), administered as a single dose for early syphilis and as three consecutive weekly doses for late syphilis or syphilis of unknown duration.

Locations (1)

Hospital de Niños Ricardo Gutierrez

Buenos Aires City, Buenos Aires, Argentina