Bronchoscopy Study - DMID 16-0063 | Tuberculosis Research Unit

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 HIV seronegative, asymptomatic adult household contact participants undergoing bronchoscopy: 150 LTBI: 50 IGRA positive (and TST positive if applicable) RLTBI: 50 IGRA negative (and TST negative if applicable) CNVT: 50 IGRA negative who convert to IRGA positive (and TST negative if applicable)
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:

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/or positive Interferon-Gamma Release Assay (IGRA) (i.e. persons with LTBI or who recently converted from TST and/or IGRA negative to IGRA positive (CNVT)) to those who are TST and/or IGRA negative (i.e. persons with RLTBI).
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/or positive IGRA (i.e. persons with LTBI or CNVT) to those who are TST and/or IGRA negative (i.e. persons with RLTBI) in parallel with Objective 1.
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/or positive IGRA (i.e. persons with LTBI or CNVT) to those who are TST and/or IGRA negative (i.e. persons with RLTBI) in parallel with Objective 1.
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/or positive IGRA (i.e. persons with LTBI or CNVT) and in those who are TST and/or IGRA negative (i.e. persons with RLTBI) in parallel with Objective 1.