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Case Western Reserve University Tuberculosis Research Unit
  Integrating research to combat the global TB epidemic
 
 

Immunologic and Microbiologic Parameters of M. tuberculosis exposure and carriage in the lungs of HIV non-infected Adult Household Contacts of Patients with Smear Positive Pulmonary Tuberculosis

(DMID Protocol Number: 10-0041)

Type of Study

Prospective Observational Household Contact Study

Design

Hybrid Cross-sectional / Cohort Study

Project Site

Kampala, Uganda (Kawempe Division and adjacent parishes)

Sample Size

104-120 subjects

Cohort 1: Index cases with active TB;
Cohort 2: TST negative adult household contacts without active TB; and
Cohort 3: TST positive adult household contacts without active TB.

Study Period

Overall study duration:

It may take up to 3 years to enroll cohorts.

Follow up duration:
Adult Household Contacts without active TB: 6 months
Active TB Index Cases: 2 months

Goal of Study:

The goal of this study is to determine the status of pulmonary host defenses and whether viable MTB bacilli can be found in the airways of healthy persons recently exposed and infected with MTB.

Objectives of Study:
  1. To define innate and adaptive immune responses to MTB in the lung following MTB exposure in healthy adult household contacts of persons with active pulmonary TB by comparing lung immune responses of those who convert their tuberculin skin test (TST) from negative to positive (TST converters, i.e. acute MTB infection) to those who remain TST negative (PTST-, i.e. exposed but not infected).
  2. To compare innate and adaptive immune responses in the peripheral blood of healthy adult household contacts of persons with active pulmonary TB, who either are already TST positive, are TST negative who become TST positive (TST converters) or are TST negative who remain TST negative (PTST-) to the lung immune responses in Objective 1.
  3. To compare the rate of positive MTB culture in induced sputum and BAL specimens of healthy adult household contacts of persons with active pulmonary TB who either are already TST positive, TST- negative who become TST positive (TST converters) or TST negative who remain TST negative (PTST-).
  4. To determine if MTB molecules (e.g. proteins, glycolipids, lipids, DNA) can be detected in induced sputum and BAL of healthy adult household contacts of persons with active pulmonary TB who either are already TST positive, TST- negative who become TST positive (TST converters) or TST negative who remain TST negative (PTST-) and used to differentiate these 3 clinical groups of contacts.
Research Activities: