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Infectious diseases
Protocol
Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): protocol for a multicentric prospective observational study
  1. Akshay Gupte1,2,
  2. Chandrasekaran Padmapriyadarsini3,
  3. Vidya Mave2,4,
  4. Dileep Kadam5,
  5. Nishi Suryavanshi4,
  6. Shri Vijay Bala Yogendra Shivakumar3,
  7. Rewa Kohli4,
  8. Nikhil Gupte2,4,
  9. Kannan Thiruvengadam3,
  10. Anju Kagal5,
  11. Sushant Meshram5,
  12. Renu Bharadwaj5,
  13. Sandhya Khadse5,
  14. Geetha Ramachandran3,
  15. Luke Elizabeth Hanna3,
  16. Neeta Pradhan4,
  17. N S Gomathy3,
  18. Andrea DeLuca1,2,
  19. Amita Gupta1,2,
  20. Soumya Swaminathan6
  21. on behalf of the CTRIUMPH Study Team
    1. 1Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA
    2. 2Johns Hopkins University School of Medicine, Baltimore, Maryland, USA
    3. 3National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India
    4. 4Johns Hopkins Clinical Trials Unit, Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India
    5. 5Byramjee Jeejeebhoy Government Medical College, Pune, Maharashtra, India
    6. 6Indian Council of Medical Research, New Delhi, India
    1. Correspondence to Dr Amita Gupta; agupta25{at}jhmi.edu

    Abstract

    Introduction Tuberculosis disease (TB) remains an important global health threat. An evidence-based response, tailored to local disease epidemiology in high-burden countries, is key to controlling the global TB epidemic. Reliable surrogate biomarkers that predict key active disease and latent TB infection outcomes are vital to advancing clinical research necessary to ‘End TB’. Well executed longitudinal studies strengthening local research capacity for addressing TB research priorities and advancing biomarker discovery are urgently needed.

    Methods and analysis The Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH) study conducted in Byramjee Jeejeebhoy Government Medical College (BJGMC), Pune and National Institute for Research in Tuberculosis (NIRT), Chennai, India, will establish and maintain three prospective cohorts: (1) an Active TB Cohort comprising 800 adults with pulmonary TB, 200 adults with extrapulmonary TB and 200 children with TB; (2) a Household Contact Cohort of 3200 adults and children at risk of developing active disease; and (3) a Control Cohort consisting of 300 adults and 200 children with no known exposure to TB. Relevant clinical, sociodemographic and psychosocial data will be collected and a strategic specimen repository established at multiple time points over 24 months of follow-up to measure host and microbial factors associated with (1) TB treatment outcomes; (2) progression from infection to active TB disease; and (3) Mycobacterium tuberculosis transmission among Indian adults and children. We anticipate CTRIUMPH to serve as a research platform necessary to characterise some relevant aspects of the TB epidemic in India, generate evidence to inform local and global TB control strategies and support novel TB biomarker discovery.

    Ethics and dissemination This study is approved by the Institutional Review Boards of NIRT, BJGMC and Johns Hopkins University, USA. Study results will be disseminated through peer-reviewed journals and research conferences.

    Funding NIH/DBT Indo-US Vaccine Action Programme and the Indian Council of Medical Research.

    • EPIDEMIOLOGY

    This is an Open Access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/

    https://doi.org/10.1136/bmjopen-2015-010542

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