Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:39 PM
Ignite Modification Date:
2025-12-24 @ 11:39 PM
NCT ID:
NCT06877351
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.
Healthy Volunteers:
False
Sex:
ALL
Maximum Age:
18 Years
Study:
NCT06877351
Study Brief:
Protocol Section:
NCT06877351