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

NCT06877351 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2025-03-14

No results posted yet for this study

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

Conditions

  • Syphilis Acquired

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.

Sponsors & Collaborators

  • Hospital de Niños R. Gutierrez de Buenos Aires

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-14
Primary Completion
2027-01-01
Completion
2027-06-01

Countries

  • Argentina

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06877351 on ClinicalTrials.gov