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 @ 11:33 PM
Ignite Modification Date:
2025-12-24 @ 11:33 PM
NCT ID:
NCT00682656
Eligibility Criteria:
Inclusion Criteria:
* Patients older than 14 and younger than 65 years old
* Skin lesions with clinical suggestion of cutaneous leishmaniasis and positive leishmanin skin test(Montenegro test)or parasitological (direct observation of leishmania amastigotes, leishmania in vitro culture from aspirates, histopathological) and molecular(Polymerase Chain Reaction - PCR)samples.
* No use of oral potentially antileishmanial drugs, or topics throughout the term of the current injury.
* Absence of disseminated leishmaniasis.
* Absence of mucosal involvement.
* Agreement to participate in the study and signed the informed consent.
Exclusion Criteria:
* Diabetes mellitus, kidney diseases, liver or cardiac diseases, tuberculosis, malaria.
* Pregnancy
* lactating mothers
* Breast feeding
* Cutaneous lesion with bacterial infection for which antibiotics need to be prescribed
* More than six cutaneous lesions
* Previous history of cutaneous or mucosal leishmaniasis
* Use of drugs with potential pharmacological interactions with antimonials as anti-arrhythmic or tricycle anti-depressives
* Previous intolerance to azithromycin or other macrolides or N-methylglucamine
* Abusive alcohol ingestion according to the CAGE questionnaire
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
14 Years
Maximum Age:
65 Years
Study:
NCT00682656
Study Brief:
Protocol Section:
NCT00682656