Bronchoscopy Study - DMID 16-0063

A Study of Immunologic and Microbiologic Parameters of M. tuberculosis Exposure and Infection in the lungs of Adult Household Contacts of Patients with Pulmonary Tuberculosis

Information:

DMID Protocol Number: 16-0063

Sponsor - U. S. National Institutes of Health
Principal Investigators – W. Henry Boom, MD, CWRU; Harriet Mayanja-Kizza, M.B.Ch.B., M.Med., PhD., Uganda-CWRU Research Collaboration

Type of Study Prospective Observational Household Contact Study
Design

Hybrid Cross-sectional / Cohort Study

Project Site

Kampala, Uganda

Sample Size

18 to 50 year old Ugandan adults who reside in Kampala, Uganda with an individual with active TB disease, and do not show signs and symptoms of active TB disease themselves

Total participants undergoing bronchoscopy – 75

  • LTBI: 25 asymptomatic TST and IGRA positive, and HIV seronegative adult household contacts
  • RLTBI: 25 asymptomatic TST and IGRA negative, and HIV seronegative adult household contacts
  • CNVT: 25 asymptomatic TST and IGRA negative who convert to IRGA positive, and HIV seronegative adult household contacts
Study Period

December 2017 to Present

Individual participant duration is approximately18 days

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 with a positive tuberculin skin test (TST) and positive Interferon gamma release assay (IGRA) (i.e. persons with LTBI) to those who are TST and IGRA negative after being exposed to a TB case for at least 1 year (i.e. persons with RLTBI).
  2. To define innate and adaptive immune responses in the peripheral blood following MTB exposure in healthy adult household contacts of persons with active pulmonary TB by comparing lung immune responses of those with a positive TST and positive IGRA (i.e. persons with LTBI) to those who are TST and IGRA negative (i.e. persons with RLTBI) in parallel with Objective 1.
  3. To compare the rate of positive MTB culture in BAL specimens of healthy adult household contacts of persons with active pulmonary TB of those with a positive TST and positive IGRA(i.e. persons with LTBI) to those who are TST and IGRA negative (i.e. persons with RLTBI) in parallel with Objective 1.
  4. To determine if MTB molecules (e.g. proteins, glycolipids, lipids, DNA) can be detected in BAL of healthy adult household contacts of persons with active pulmonary TB who have a positive TST and positive IGRA(i.e. persons with LTBI) and in those who are TST and IGRA negative (i.e. persons with RLTBI) in parallel with Objective 1.