The Regional Prospective Observational Research In Tuberculosis (Report) India Phase II Common Protocol

Purpose and Scientific Aims

The purpose of the RePORT India Phase II Common Protocol is to collect and utilize data and specimens for tuberculosis (TB) research, leveraging the existing infrastructure, processes, and scientific partnerships established under RePORT India consortium. The RePORT India Phase II Common Protocol includes five specific scientific aims:

AIM 1. DIAGNOSTICS:  Evaluate Novel Diagnostics & Biomarkers of Diverse States of Mtb Infection

AIM 2. MARKERS OF TREATMENT RESPONSE:

2.A: Identify TB Treatment Response Biomarkers

2.B: Investigate Host-Related Mechanisms of Treatment Failure

2.C: Investigate Pathogen-related Mechanisms & Predictors of Recurrence

AIM 3. LUNG INJURY & IMPAIRMENT: Identify Markers of Lung Injury Associated with Unfavorable TB Treatment Outcomes.

AIM 4. RESISTANCE TO INFECTION: Mechanisms of Protection against TB in Exposed Persons

4.A: Examine Host Antimicrobial Pathways in Inducing their infection resistant (IR) Phenotype in HHC

4.B: Test if IR & Plasma Differ in Modulating Macrophage-Mediated Restriction of Mtb Growth & Evaluate AB Repertoires of Plasma from the IR and infection susceptible (IS) Cohorts

AIM 5. PROGRESSION TO DISEASE: Identify Immunologic Markers of Persons at Highest Risk of Progress of Latent TB Infection to TB.

5.A: Stored Samples: Validation of PREDICT29 in Progressors & Nonprogressors from RePORT Sites

5.B: Immune & Hormone Studies in Freshly Collected Samples