Molecular and Immunological Tools for Detection of Strain Diversity, Drug Resistance and Immunological Responses
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ClinicalTrials.gov Identifier: NCT00138437 |
Recruitment Status
:
Completed
First Posted
: August 30, 2005
Last Update Posted
: November 7, 2014
|
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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:
- healthy persons with no known contact with leprosy patients
- 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
- 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.
Condition or disease |
---|
Leprosy |
Study Type : | Observational |
Actual Enrollment : | 1554 participants |
Observational Model: | Cohort |
Time Perspective: | Cross-Sectional |
Official Title: | Molecular Epidemiology of Leprosy in Colombia |
Study Start Date : | April 2006 |
Actual Primary Completion Date : | April 2013 |
Actual Study Completion Date : | April 2013 |

Group/Cohort |
---|
Leprosy Patients (Group 1)
All leprosy patients
|
Household Contacts (Group 2)
Household contacts with known contact with leprosy patients
|
Healthy Individuals (Group 3)
Healthy persons with no known contact with leprosy patients
|
- Strain typing: identification of genotypes [ Time Frame: Dec, 2010 ]
Biospecimen Retention: Samples With DNA

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 70 Years (Adult, Senior) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Sampling Method: | Non-Probability Sample |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00138437
Colombia | |
Impresa Socail del Estado Sanatorio Agua de Dios | |
Agua de Dios City, Colombia | |
Instituto Colombiano de Medicina Tropical-CES | |
Sabaneta, Colombia |
Principal Investigator: | Varalakshmi Vissa, PhD | Colorado State University | |
Principal Investigator: | Nora Cardona-Castro, MD, MSc | Instituto Colombiano de Medicina Tropical - Universidad CES |
Responsible Party: | Colorado State University |
ClinicalTrials.gov Identifier: | NCT00138437 History of Changes |
Other Study ID Numbers: |
09-817H |
First Posted: | August 30, 2005 Key Record Dates |
Last Update Posted: | November 7, 2014 |
Last Verified: | November 2014 |
Keywords provided by Colorado State University:
leprosy Colombia |
Additional relevant MeSH terms:
Leprosy Mycobacterium Infections Actinomycetales Infections Gram-Positive Bacterial Infections Bacterial Infections |