Leprosy Clinical Trial
Official title:
Molecular Epidemiology of Leprosy in Colombia
Verified date | November 2014 |
Source | Colorado State University |
Contact | n/a |
Is FDA regulated | No |
Health authority | Colombia: Institutional Review Board |
Study type | Observational |
The purpose of this study is to determine what factors contribute to the continued incidence
of leprosy in Colombia. Study participants will include volunteering and consenting
individuals, older than 4 years of age, representing three study groups:
1. healthy persons with no known contact with leprosy patients
2. patients reporting at Instituto Colombiano de Medicina Tropical-CES and Impresa Social
del Estado Sanatorio Agua de Dios with a new diagnosis of leprosy or relapse of leprosy
3. household contacts of leprosy patients described in group 2. Blood, nasal swabs, slit
skin smears, and biopsies will be taken from the volunteers to learn the strains of
leprosy-causing bacteria in the area, the immune responses (body's response to disease)
in local residents against the bacteria, and the pattern of leprosy transmission.
Individuals will participate in this study for 1-10 days, and the study will last for 3
years.
Status | Completed |
Enrollment | 1554 |
Est. completion date | April 2013 |
Est. primary completion date | April 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
Inclusion Criteria: - All leprosy patients (Group1), their household contacts (Group 2) and healthy persons with no known contacts with leprosy patients (Group 3), between the ages of 18 and 70 years willing to participate in this study. Exclusion Criteria: - Patients unwilling to participate or unable to give informed consent will be excluded from the study. - Pregnant women will be excluded. Exclusion criteria for objective A.5 are one or more of the following conditions: - Chronic illnesses such as cancer - Diabetes - Hepatitis - HIV - Tuberculosis - Undergoing corticosteroid therapy - Current or previous history of immunosuppressive therapy as assessed from medical records and interviews with a physician. |
Observational Model: Cohort, Time Perspective: Cross-Sectional
Country | Name | City | State |
---|---|---|---|
Colombia | Impresa Socail del Estado Sanatorio Agua de Dios | Agua de Dios City | |
Colombia | Instituto Colombiano de Medicina Tropical-CES | Sabaneta |
Lead Sponsor | Collaborator |
---|---|
Colorado State University | National Institute of Allergy and Infectious Diseases (NIAID) |
Colombia,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Strain typing: identification of genotypes | Dec, 2010 | No |
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