Status:
ACTIVE_NOT_RECRUITING
Oral Amoxicillin Compared to Penicillin G Benzathine for the Treatment of Acquired Syphilis.
Lead Sponsor:
Hospital de Niños R. Gutierrez de Buenos Aires
Conditions:
Syphilis Acquired
Eligibility:
All Genders
Up to 18 years
Phase:
PHASE3
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 ab...
Detailed Description
A randomized, phase III, multicenter, prospective, open-label, non-inferiority clinical trial in pediatric outpatients with a diagnosis of acquired syphilis has been designed in order to compare oral ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
- 1\. Known allergy or hypersensitivity to any of the investigational drugs or their excipients, particularly to penicillin, cephalosporins, or other beta-lactam agents.
- 2\. 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.
- 5\. 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.
- 7\. 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.
- 10\. Anticipated noncompliance with the protocol, treatment, or clinical trial testing and follow-up, as judged by the investigator.
- 11\. Cases involving prosecuted sexual abuse.
Key Trial Info
Start Date :
August 14 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06877351
Start Date
August 14 2024
End Date
June 1 2027
Last Update
March 14 2025
Active Locations (1)
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1
Hospital de Niños Ricardo Gutierrez
Buenos Aires City, Buenos Aires, Argentina, C1425EFD