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 @ 6:43 PM
Ignite Modification Date:
2025-12-24 @ 6:43 PM
NCT ID:
NCT00401557
Eligibility Criteria:
Inclusion Criteria:
For specific objectives 1, 3 and 4:
Historical cases of chronic disease:
* Age between 18-70 years
* Historic parasitologically confirmed, skin test positive cutaneous leishmaniasis (CL) patients who presented chronic CL lesions of \> 6 months duration at the time of diagnosis
* No active lesions
* Voluntary participation in the study
* Written and signed Informed consent for HIV testing and participation in the study
Historical cases of recurrent disease:
* Age between 18-70 years
* Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
* No active lesions
* Voluntary participation in the study
* Written and signed Informed consent for HIV testing and participation in the study
Asymptomatic infection:
* Age between 18-70 years
* Resident of endemic area
* No history or evidence of active or prior dermal leishmaniasis
* Voluntary participation
* Written and signed Informed consent for HIV testing and participation in the study
Healthy donors:
* Age between 18-70 years
* No history or evidence of exposure to transmission of leishmaniasis
* Voluntary participation
* Written and signed Informed consent for HIV testing and participation in the study
For specific objective 2:
Historical cases of chronic disease:
* Age between 18-70 years
* Historic parasitologically confirmed, skin test positive CL patients who presented chronic CL lesions of \> 6 months duration at the time of diagnosis
* No active lesions
* Voluntary participation in the study
* Written and signed Informed consent for HIV testing and participation in the study
Historical cases of recurrent disease:
* Age between 18-70 years
* Historic CL patients who have developed new parasitologically confirmed lesions after resolution of prior disease
* No active lesions
* Voluntary participation in the study
* Written and signed Informed consent for HIV testing and participation in the study
Asymptomatic infection:
* Age between 18-70 years
* Resident of endemic area
* No history or evidence of active or prior dermal leishmaniasis
* Voluntary participation
* Written and signed Informed consent for HIV testing and participation in the study
Healthy donors:
* Age between 18-70 years
* No history or evidence of exposure to transmission of leishmaniasis
* Voluntary participation
* Written and signed Informed consent for HIV testing and participation in the study
Exclusion Criteria:
Exclusion criteria for all groups (for specific objectives 1, 3 and 4):
* Immunosuppressive disease
* Pharmacotherapy with drugs that are immunosuppressive
* Pregnancy
* Breastfeeding
* Unwillingness to participate
Exclusion criteria for all groups (for specific objective 2):
* Weight below 50kg
* Immunosuppressive disease (HIV)
* Treatment with drugs that are immunosuppressive
* Pregnancy
* Breastfeeding
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
70 Years
Study:
NCT00401557
Study Brief:
Protocol Section:
NCT00401557