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

NCT06877351 | Active Not Recruiting Phase 3

• 1 other identifier: 13246
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

penicillin alternatives; non-inferiority study; treponema pallidum; children; adolescents; oral amoxicillin

Outcome Measures

Primary Outcomes (1)

• Therapeutic Response Criteria

  •Serologic Response: An adequate serologic response is defined as a fourfold (2 dilutions) decrease in rapid plasma reagin (RPR) titer or seroconversion to a negative result during follow-up (6-12 months post-treatment).

  2 weeks to 12 months

Secondary Outcomes (3)

• Adverse Events

  8 weeks

• Treatment Tolerance

  8 weeks

• Antibiotic Response

  2 weeks to 12 months

Study Arms (2)

Amoxicillin

EXPERIMENTAL

Amoxicillin: Administered orally at a dosage of 40-50 mg/kg/day, divided into three doses. The treatment duration is 14 days for early syphilis and 21 days for late syphilis or syphilis of unknown duration. The maximum dose is 500 mg every 8 hours.

Drug: Amoxicillin

Intramuscular Penicillin G Benzathine:

ACTIVE COMPARATOR

Intramuscular Penicillin G Benzathine: Administered as a single dose of 50,000 IU/kg for early syphilis, and as three consecutive weekly doses for late syphilis or syphilis of unknown duration. The maximum dose is 2,400,000 IU per dose.

Drug: Penicillin G, Benzathine

Interventions

Amoxicillin DRUG

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.

Amoxicillin

Penicillin G, Benzathine DRUG

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.

Intramuscular Penicillin G Benzathine:

Eligibility Criteria

• Age: Up to 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age up to 18 years.
• Diagnosis of primary, secondary, or early latent syphilis, based on national and international standards (16, 17, 18).
• Signed informed consent and assent.
• Ability to comply with the study protocol requirements.
• For women of childbearing potential, use of a highly effective contraceptive method (e.g., abstinence, hormonal contraception, or intrauterine device (IUD) is required. Contraception must be maintained for 1 week after the completion of treatment.
• Male participants are advised to use condoms during sexual intercourse to prevent the transmission of syphilis to their partners.

You may not qualify if:

• \. Known allergy or hypersensitivity to any of the investigational drugs or their excipients, particularly to penicillin, cephalosporins, or other beta-lactam agents.
• \. Diagnosis of clinical neurosyphilis. 3. Pregnant or lactating women. 4. Recent antibiotic treatment (within the past week) with drugs potentially active against Treponema pallidum, such as beta-lactams, cephalosporins, macrolides, or tetracyclines.
• \. Acute or chronic renal failure with a declining glomerular filtration rate. 6. Concomitant symptomatic sexually transmitted diseases (e.g., gonorrhea, chlamydia, lymphogranuloma venereum, Mycoplasma genitalium) or other infectious diseases requiring antibiotic treatment that could affect T. pallidum.
• \. Previous treatment for diagnosed syphilis. 8. Conditions that prevent oral administration of medication. 9. Other acute or chronic ailments or congenital disorders that, in the investigator's judgment, contraindicate participation in the trial or may interfere with the assessment of the efficacy, safety, or pharmacokinetics of the investigational product.
• \. Anticipated noncompliance with the protocol, treatment, or clinical trial testing and follow-up, as judged by the investigator.
• \. Cases involving prosecuted sexual abuse.

Sponsors & Collaborators

• Hospital de Niños R. Gutierrez de Buenos Aires: lead

Study Sites (1)

Hospital de Niños Ricardo Gutierrez

Buenos Aires City, Buenos Aires, C1425EFD, Argentina

Location

MeSH Terms

Conditions

Treponemal Infections

Interventions

Amoxicillin; Penicillin G

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Ampicillin; Penicillins; beta-Lactams; Lactams; Amides; Organic Chemicals; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: open-label
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof Dr Guillermo F Moscatelli

Model Details: Randomized, phase III, multicenter, prospective, open-label, non-inferiority clinical trial.

Study Record Dates

• First Submitted: March 5, 2025
• First Posted: March 14, 2025
• Study Start: August 14, 2024
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: March 14, 2025

Record last verified: 2024-12

Locations

AR (1)