PROJECT

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

Feb 2021 - Sep 2026

Objectives:

Evaluate Novel Diagnostics & Biomarkers of Diverse States of MTB Infection Markers of Treatment Response Identification of markers of lung injury associated with unfavourable TB treatment outcomes. Identification of immunological markers of persons at highest risk of progress of LTBI to TB.

Study Overview:

RePORT- India was implemented in sequential phases from 2014.. In 2019, a Phase I Common Protocol was introduced to harmonise clinical assessments, laboratory workflows, bio specimen collection and handling, and digital data capture across participating sites. Phase II expanded the consortium to additional clinical research units and further refined research priorities, with increased emphasis on harmonisation, sustainability, and translational relevance.

Study Approach:

RePORT-India developed three major longitudinal cohorts: Diagnostic cohort: Individual with Presumptive TB enrolling at time of initial presentation with symptoms diagnostic confirmation. Cohort A: Confirmed TB cohorts, including adult pulmonary, paediatric, and extra pulmonary TB; Cohort B: Household contact cohorts of confirmed TB followed for latent infection and progression to disease. Together, these cohorts enabled investigations across the full spectrum of TB from early disease detection and treatment response to transmission dynamics and post-exposure risk.

Expected Public Health Impact:

The long-term goal of this study is to provide scientific evidence that can be translated into effective TB control. The positive impact of biomarkers on predicting TB outcomes, shortening product development timelines, or yielding effective prevention strategies may benefit future patients with TB.