Leishmaniasis Clinical Trial
Official title:
Immune and Inflammatory Responses in L. (Viannia) Infection Aim 2: Expression of Mif Alleles in Individuals With Recurrent Leishmaniasis, Chronic Leishmaniasis and Asymptomatic Infection
Verified date | August 2011 |
Source | Yale University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
CIDEIM, Centro Internacional de Entrenamiento e Investigaciones Medicas, is conducting a research study about the disease Cutaneous Leishmaniasis, which is caused by the Leishmania parasite and causes skin sores. Researchers hope to find out how the human body defends against Leishmania. A total of 472 individuals, ages 7 to 70 years, belonging to one of the following groups will be included in this study: recurring disease, chronic disease, disease with no sign or symptoms (asymptomatic), and healthy individuals. Study procedures will include a questionnaire and buccal swab (swabbing of the inside of the cheek with a cotton or wooden applicator). In addition, asymptomatic and healthy individuals will provide a blood sample. Study participation will be up to 1.5 hours.
Status | Completed |
Enrollment | 438 |
Est. completion date | April 2010 |
Est. primary completion date | |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 7 Years to 70 Years |
Eligibility |
Inclusion Criteria: Active or historical cases of recurrent cutaneous leishmaniasis - Age 7-70 years - History of parasitologically confirmed (at time of diagnosis) recurrent leishmaniasis - Voluntary participation in the study - Written and signed Informed consent/assent forms Active or historical cases of chronic cutaneous leishmaniasis - Age 7-70 years - History of parasitologically confirmed (at time of diagnosis) chronic leishmaniasis - Voluntary participation in the study - Written and signed Informed consent/assent forms Asymptomatic infection - Age 7-70 years - Resident of endemic area - No history or evidence of active or prior dermal leishmaniasis - Voluntary participation in the study - Written and signed Informed consent/assent forms Healthy donors - Age 7-70 years - No history or evidence of exposure to transmission of leishmaniasis - Voluntary participation in the study - Written and signed Informed consent/assent forms Exclusion Criteria: Pregnancy |
Country | Name | City | State |
---|---|---|---|
Colombia | Centro Internacional de Entrenamiento e Investigaciones Medicas, CIDEIM | Cali |
Lead Sponsor | Collaborator |
---|---|
Yale University | National Institute of Allergy and Infectious Diseases (NIAID) |
Colombia,
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