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:
2025-12-25 @ 3:52 AM
Ignite Modification Date:
2025-12-25 @ 3:52 AM
NCT ID:
NCT02979002
Eligibility Criteria:
Inclusion Criteria:
* Participants with suspected Cutaneous Leishmaniasis wound(s) in apparently healthy state
* Who is able to learn the Information sheet and sign the Informed consent form by them selves or by their parents with the presence or not of a witness (for illiterate people)
* Who satisfy the following criteria :
* with an ulcerative lesion in any accessible part of the body to perform the dental broach and the scraping.
* Just one ulcerative lesion by patient could be selected (The newest and the less infected)
* Lesion should be less than 04 months of age
Exclusion Criteria:
* Patients with only nodular, papular, macular or nodulo-papular suspected CL forms
* Patients with ulcerative lesions with a suspected bacteria origin which could disappear after a short course of antibiotic treatment.
* Patients who already received during the last two months, prior to signing the consent, a physical treatment (e.g. cryotherapy, thermotherapy, Laser) or a traditional treatment (e.g. burn, acide, traditional scraping)
* Patients presenting other disease with the need to take anti-parasite treatments
* Patient with a acute or chronic disease needing hospitalization
* Patient who already received antimoniate treatment incomplete or complete duration and dose against CL
* Any situation that could engage the security of the patient or of the health professional (e.g. People with a psychiatric trouble or a mental handicap )
* For children less than 12 years old, the decision of participation is mainly based on the condition that their parents are able to learn and understand the information sheet and sign the informed consent form
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
5 Years
Study:
NCT02979002
Study Brief:
Protocol Section:
NCT02979002