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Active Not Recruiting NCT06877351

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

Conditions: Syphilis Acquired

Sex: All
Ages: N/A – 18 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 120
Sponsor: Hospital de Niños R. Gutierrez de Buenos Aires

Location: Hospital de Niños Ricardo Gutierrez Buenos Aires City Buenos Aires

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

Eligibility Criteria

Inclusion Criteria: 1. Age up to 18 years. 2. Diagnosis of primary, secondary, or early latent syphilis, based on national and international standards (16, 17, 18). 3. Signed informed consent and assent. 4. Ability to comply with the study protocol requirements. 5. 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. 6. Male participants are advised to use condoms during sexual intercourse to prevent the transmission of syphilis to their partners. Exclusion Criteria: * 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.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT06877351). StuddyBuddy aggregates publicly available trial information.