Molecular and Immunological Tools for Detection of Strain Diversity, Drug Resistance and Immunological Responses

NCT00138437 | Completed

• 1 other identifier: 09-817H
• Study Type: observational
• Target: 1,554
• Locations: 1 country
• Sites: 2

Brief Summary

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. 1.healthy persons with no known contact with leprosy patients
2. 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. 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.

Conditions

Leprosy

Keywords

leprosy; Colombia

Outcome Measures

Primary Outcomes (1)

• Strain typing: identification of genotypes

  Dec, 2010

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Study participants for prospective sample collections will include volunteering and consenting individuals older than 18 years of age, representing three study groups

You may qualify if:

• 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.

You may not qualify if:

• Patients unwilling to participate or unable to give informed consent will be excluded from the study.
• Pregnant women will be excluded.
• 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.

Sponsors & Collaborators

• Colorado State University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (2)

Impresa Socail del Estado Sanatorio Agua de Dios

Agua de Dios, Colombia

Location

Instituto Colombiano de Medicina Tropical-CES

Sabaneta, Colombia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Blood, Nasal Swabs, Skin Biopsies and scrapings

MeSH Terms

Conditions

Leprosy

Condition Hierarchy (Ancestors)

Mycobacterium Infections, Nontuberculous; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Varalakshmi Vissa, PhD

  Colorado State University

  PRINCIPAL INVESTIGATOR

• Nora Cardona-Castro, MD, MSc

  Instituto Colombiano de Medicina Tropical - Universidad CES

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2005
• First Posted: August 30, 2005
• Study Start: April 1, 2006
• Primary Completion: April 1, 2013
• Study Completion: April 1, 2013
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

CO (2)