Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): Protocol for a multicentric prospective observational study

Akshay Gupte; Chandrasekaran Padmapriyadarsini; Vidya Mave; Dileep Kadam; Nishi Suryavanshi; Shri Vijay Bala Yogendra Shivakumar; Rewa Kohli; Nikhil Gupte; Kannan Thiruvengadam; Anju Kagal; Sushant Meshram; Renu Bharadwaj; Sandhya Khadse; Geetha Ramachandran; Luke Elizabeth Hanna; Neeta Pradhan; N. S. Gomathy; Andrea DeLuca; Amita Gupta; Soumya Swaminathan; Aarti Kinikar; Alamelu Raja; Amita Nagraj; B. Anand Kumar; Anita More; Archana Gaikwad; Ashwini Nangude; S. Balaji; Beena Thomas; Bency Joseph; T. K. Bharath; B. Brindha; David Dowdy; Deepak Pole; A. Devanathan; M. Devi Sangamithrai; Divyashri Jain; C. K. Dolla; Gabriela Smit; R. Gangadarsharma; Hanumant Chaugule; Hari Koli; Hemanthkumar; J. Jeeva; Jessica Elf; Jonathan Golub; Jyoti Chandane; Kanade Savita; M. Kannan; M. Karthikesh; S. Karunakaran; Kelly Dooley; Lakshmi Murali; M. Lavanya; S. Madasamy; M. Mageshkumar; S. Mangaiyarkarasi; Mahesh Gujare; S. Manoharan; M. Michel Premkumar; P. Munivardhan; S. Murugesan; N. S. Gomathy; Nagaraj; C. Ponnuraja; N. Premkumar; Rahul Lokhande; S. Rajkumar; K. Ranganathan; S. Rani; Renu Madewar; Robert Bollinger; Rosemarie Warlick; Rupak Shivakoti; Sahadev Javanjal; P. Sathyamurthi; Shalini Pawar; Shashank Hande; Shital Muley; Shital Sali; K. Shubhapriya; Shyam Biswal; K. Silambu Chelvi; Smita Nimkar; Sriram Selvaraj; Sundeep Salvi; Swapnil Raskar; Uma Devi; Vandana Kulkarni; Vidula Hulyalkar; Vinod Tayawade; Vrinda Bansode; Yogesh Daware

doi:10.1136/bmjopen-2015-010542

Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): Protocol for a multicentric prospective observational study

Akshay Gupte, Chandrasekaran Padmapriyadarsini, Vidya Mave, Dileep Kadam, Nishi Suryavanshi, Shri Vijay Bala Yogendra Shivakumar, Rewa Kohli, Nikhil Gupte, Kannan Thiruvengadam, Anju Kagal, Sushant Meshram, Renu Bharadwaj, Sandhya Khadse, Geetha Ramachandran, Luke Elizabeth Hanna, Neeta Pradhan, N. S. Gomathy, Andrea DeLuca, Amita Gupta, Soumya SwaminathanAarti Kinikar, Alamelu Raja, Amita Nagraj, B. Anand Kumar, Anita More, Archana Gaikwad, Ashwini Nangude, S. Balaji, Beena Thomas, Bency Joseph, T. K. Bharath, B. Brindha, David Dowdy, Deepak Pole, A. Devanathan, M. Devi Sangamithrai, Divyashri Jain, C. K. Dolla, Gabriela Smit, R. Gangadarsharma, Hanumant Chaugule, Hari Koli, Hemanthkumar, J. Jeeva, Jessica Elf, Jonathan Golub, Jyoti Chandane, Kanade Savita, M. Kannan, M. Karthikesh, S. Karunakaran, Kelly Dooley, Lakshmi Murali, M. Lavanya, S. Madasamy, M. Mageshkumar, S. Mangaiyarkarasi, Mahesh Gujare, S. Manoharan, M. Michel Premkumar, P. Munivardhan, S. Murugesan, N. S. Gomathy, Nagaraj, C. Ponnuraja, N. Premkumar, Rahul Lokhande, S. Rajkumar, K. Ranganathan, S. Rani, Renu Madewar, Robert Bollinger, Rosemarie Warlick, Rupak Shivakoti, Sahadev Javanjal, P. Sathyamurthi, Shalini Pawar, Shashank Hande, Shital Muley, Shital Sali, K. Shubhapriya, Shyam Biswal, K. Silambu Chelvi, Smita Nimkar, Sriram Selvaraj, Sundeep Salvi, Swapnil Raskar, Uma Devi, Vandana Kulkarni, Vidula Hulyalkar, Vinod Tayawade, Vrinda Bansode, Yogesh Daware

Research output: Contribution to journal › Article › peer-review

19 Scopus citations

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.

Original language	English (US)
Article number	e010542
Journal	BMJ open
Volume	6
Issue number	2
DOIs	https://doi.org/10.1136/bmjopen-2015-010542
State	Published - 2016

ASJC Scopus subject areas

General Medicine

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10.1136/bmjopen-2015-010542

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Gupte, A., Padmapriyadarsini, C., Mave, V., Kadam, D., Suryavanshi, N., Shivakumar, S. V. B. Y., Kohli, R., Gupte, N., Thiruvengadam, K., Kagal, A., Meshram, S., Bharadwaj, R., Khadse, S., Ramachandran, G., Hanna, L. E., Pradhan, N., Gomathy, N. S., DeLuca, A., Gupta, A., ... Daware, Y. (2016). Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): Protocol for a multicentric prospective observational study. BMJ open, 6(2), Article e010542. https://doi.org/10.1136/bmjopen-2015-010542

Gupte, A, Padmapriyadarsini, C, Mave, V, Kadam, D, Suryavanshi, N, Shivakumar, SVBY, Kohli, R, Gupte, N, Thiruvengadam, K, Kagal, A, Meshram, S, Bharadwaj, R, Khadse, S, Ramachandran, G, Hanna, LE, Pradhan, N, Gomathy, NS, DeLuca, A , Gupta, A, Swaminathan, S, Kinikar, A, Raja, A, Nagraj, A, Anand Kumar, B, More, A, Gaikwad, A, Nangude, A, Balaji, S, Thomas, B, Joseph, B, Bharath, TK, Brindha, B, Dowdy, D, Pole, D, Devanathan, A, Devi Sangamithrai, M, Jain, D, Dolla, CK, Smit, G, Gangadarsharma, R, Chaugule, H, Koli, H, Hemanthkumar, Jeeva, J, Elf, J, Golub, J, Chandane, J, Savita, K, Kannan, M, Karthikesh, M, Karunakaran, S, Dooley, K, Murali, L, Lavanya, M, Madasamy, S, Mageshkumar, M, Mangaiyarkarasi, S, Gujare, M, Manoharan, S, Michel Premkumar, M, Munivardhan, P, Murugesan, S, Gomathy, NS, Nagaraj, Ponnuraja, C, Premkumar, N, Lokhande, R, Rajkumar, S, Ranganathan, K, Rani, S, Madewar, R, Bollinger, R, Warlick, R, Shivakoti, R, Javanjal, S, Sathyamurthi, P, Pawar, S, Hande, S, Muley, S, Sali, S, Shubhapriya, K, Biswal, S, Silambu Chelvi, K, Nimkar, S, Selvaraj, S, Salvi, S, Raskar, S, Devi, U, Kulkarni, V, Hulyalkar, V, Tayawade, V, Bansode, V & Daware, Y 2016, 'Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): Protocol for a multicentric prospective observational study', BMJ open, vol. 6, no. 2, e010542. https://doi.org/10.1136/bmjopen-2015-010542

@article{23002d9274ee4f81b515d02f440ca2e0,

title = "Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): Protocol for a multicentric prospective observational study",

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.",

author = "Akshay Gupte and Chandrasekaran Padmapriyadarsini and Vidya Mave and Dileep Kadam and Nishi Suryavanshi and Shivakumar, {Shri Vijay Bala Yogendra} and Rewa Kohli and Nikhil Gupte and Kannan Thiruvengadam and Anju Kagal and Sushant Meshram and Renu Bharadwaj and Sandhya Khadse and Geetha Ramachandran and Hanna, {Luke Elizabeth} and Neeta Pradhan and Gomathy, {N. S.} and Andrea DeLuca and Amita Gupta and Soumya Swaminathan and Aarti Kinikar and Alamelu Raja and Amita Nagraj and {Anand Kumar}, B. and Anita More and Archana Gaikwad and Ashwini Nangude and S. Balaji and Beena Thomas and Bency Joseph and Bharath, {T. K.} and B. Brindha and David Dowdy and Deepak Pole and A. Devanathan and {Devi Sangamithrai}, M. and Divyashri Jain and Dolla, {C. K.} and Gabriela Smit and R. Gangadarsharma and Hanumant Chaugule and Hari Koli and Hemanthkumar and J. Jeeva and Jessica Elf and Jonathan Golub and Jyoti Chandane and Kanade Savita and M. Kannan and M. Karthikesh and S. Karunakaran and Kelly Dooley and Lakshmi Murali and M. Lavanya and S. Madasamy and M. Mageshkumar and S. Mangaiyarkarasi and Mahesh Gujare and S. Manoharan and {Michel Premkumar}, M. and P. Munivardhan and S. Murugesan and Gomathy, {N. S.} and Nagaraj and C. Ponnuraja and N. Premkumar and Rahul Lokhande and S. Rajkumar and K. Ranganathan and S. Rani and Renu Madewar and Robert Bollinger and Rosemarie Warlick and Rupak Shivakoti and Sahadev Javanjal and P. Sathyamurthi and Shalini Pawar and Shashank Hande and Shital Muley and Shital Sali and K. Shubhapriya and Shyam Biswal and {Silambu Chelvi}, K. and Smita Nimkar and Sriram Selvaraj and Sundeep Salvi and Swapnil Raskar and Uma Devi and Vandana Kulkarni and Vidula Hulyalkar and Vinod Tayawade and Vrinda Bansode and Yogesh Daware",

year = "2016",

doi = "10.1136/bmjopen-2015-010542",

language = "English (US)",

volume = "6",

journal = "BMJ open",

issn = "2044-6055",

publisher = "BMJ Publishing Group",

number = "2",

}

TY - JOUR

T1 - Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH)

T2 - Protocol for a multicentric prospective observational study

AU - Gupte, Akshay

AU - Padmapriyadarsini, Chandrasekaran

AU - Mave, Vidya

AU - Kadam, Dileep

AU - Suryavanshi, Nishi

AU - Shivakumar, Shri Vijay Bala Yogendra

AU - Kohli, Rewa

AU - Gupte, Nikhil

AU - Thiruvengadam, Kannan

AU - Kagal, Anju

AU - Meshram, Sushant

AU - Bharadwaj, Renu

AU - Khadse, Sandhya

AU - Ramachandran, Geetha

AU - Hanna, Luke Elizabeth

AU - Pradhan, Neeta

AU - Gomathy, N. S.

AU - DeLuca, Andrea

AU - Gupta, Amita

AU - Swaminathan, Soumya

AU - Kinikar, Aarti

AU - Raja, Alamelu

AU - Nagraj, Amita

AU - Anand Kumar, B.

AU - More, Anita

AU - Gaikwad, Archana

AU - Nangude, Ashwini

AU - Balaji, S.

AU - Thomas, Beena

AU - Joseph, Bency

AU - Bharath, T. K.

AU - Brindha, B.

AU - Dowdy, David

AU - Pole, Deepak

AU - Devanathan, A.

AU - Devi Sangamithrai, M.

AU - Jain, Divyashri

AU - Dolla, C. K.

AU - Smit, Gabriela

AU - Gangadarsharma, R.

AU - Chaugule, Hanumant

AU - Koli, Hari

AU - Hemanthkumar,

AU - Jeeva, J.

AU - Elf, Jessica

AU - Golub, Jonathan

AU - Chandane, Jyoti

AU - Savita, Kanade

AU - Kannan, M.

AU - Karthikesh, M.

AU - Karunakaran, S.

AU - Dooley, Kelly

AU - Murali, Lakshmi

AU - Lavanya, M.

AU - Madasamy, S.

AU - Mageshkumar, M.

AU - Mangaiyarkarasi, S.

AU - Gujare, Mahesh

AU - Manoharan, S.

AU - Michel Premkumar, M.

AU - Munivardhan, P.

AU - Murugesan, S.

AU - Gomathy, N. S.

AU - Nagaraj,

AU - Ponnuraja, C.

AU - Premkumar, N.

AU - Lokhande, Rahul

AU - Rajkumar, S.

AU - Ranganathan, K.

AU - Rani, S.

AU - Madewar, Renu

AU - Bollinger, Robert

AU - Warlick, Rosemarie

AU - Shivakoti, Rupak

AU - Javanjal, Sahadev

AU - Sathyamurthi, P.

AU - Pawar, Shalini

AU - Hande, Shashank

AU - Muley, Shital

AU - Sali, Shital

AU - Shubhapriya, K.

AU - Biswal, Shyam

AU - Silambu Chelvi, K.

AU - Nimkar, Smita

AU - Selvaraj, Sriram

AU - Salvi, Sundeep

AU - Raskar, Swapnil

AU - Devi, Uma

AU - Kulkarni, Vandana

AU - Hulyalkar, Vidula

AU - Tayawade, Vinod

AU - Bansode, Vrinda

AU - Daware, Yogesh

PY - 2016

Y1 - 2016

N2 - 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.

AB - 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.

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UR - http://www.scopus.com/inward/citedby.url?scp=84960370996&partnerID=8YFLogxK

U2 - 10.1136/bmjopen-2015-010542

DO - 10.1136/bmjopen-2015-010542

M3 - Article

C2 - 26916698

AN - SCOPUS:84960370996

SN - 2044-6055

VL - 6

JO - BMJ open

JF - BMJ open

IS - 2

M1 - e010542

ER -

Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): Protocol for a multicentric prospective observational study

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