印美医学合作结核病研究队列（CTRIUMPH）：一项多中心前瞻性观察性研究的方案
Cohort for Tuberculosis Research by the Indo-US Medical Partnership (CTRIUMPH): protocol for a multicentric prospective observational study.
作者信息
Gupte Akshay, Padmapriyadarsini Chandrasekaran, Mave Vidya, Kadam Dileep, Suryavanshi Nishi, Shivakumar Shri Vijay Bala Yogendra, Kohli Rewa, Gupte Nikhil, Thiruvengadam Kannan, Kagal Anju, Meshram Sushant, Bharadwaj Renu, Khadse Sandhya, Ramachandran Geetha, Hanna Luke Elizabeth, Pradhan Neeta, Gomathy N S, DeLuca Andrea, Gupta Amita, Swaminathan Soumya
机构信息
Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, USA Johns Hopkins University School of Medicine, Baltimore, Maryland, USA.
National Institute for Research in Tuberculosis, Chennai, Tamil Nadu, India.
出版信息
BMJ Open. 2016 Feb 25;6(2):e010542. doi: 10.1136/bmjopen-2015-010542.
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.
引言
结核病仍然是全球重要的健康威胁。在高负担国家，根据当地疾病流行病学情况采取循证应对措施是控制全球结核病流行的关键。可靠的替代生物标志物可预测关键的活动性疾病和潜伏性结核感染结果，对于推进“终结结核病”所需的临床研究至关重要。迫切需要精心开展纵向研究，以加强当地应对结核病研究重点和推进生物标志物发现的研究能力。
方法与分析
由印美医学合作开展的结核病研究队列（CTRIUMPH）研究将在印度浦那的拜拉姆吉·杰吉博伊政府医学院（BJGMC）和金奈的国家结核病研究所（NIRT）进行，该研究将建立并维持三个前瞻性队列：（1）一个活动性结核队列，包括800名成年肺结核患者、200名成年肺外结核患者和200名儿童结核患者；（2）一个由3200名有患活动性疾病风险的成人和儿童组成的家庭接触者队列；（3）一个由300名无已知结核接触史的成人和200名儿童组成的对照队列。将收集相关的临床、社会人口学和心理社会数据，并在24个月的随访期间的多个时间点建立一个战略标本库，以测量与以下方面相关的宿主和微生物因素：（1）结核病治疗结果；（2）从感染进展到活动性结核病；（3）结核分枝杆菌在印度成人和儿童中的传播。我们预计CTRIUMPH将作为一个研究平台，用于描述印度结核病流行的一些相关方面，生成证据以指导当地和全球结核病控制策略，并支持新型结核病生物标志物的发现。
伦理与传播
本研究已获得NIRT、BJGMC和美国约翰·霍普金斯大学机构审查委员会的批准。研究结果将通过同行评审期刊和研究会议进行传播。
资金
美国国立卫生研究院/印度生物技术部印美疫苗行动计划和印度医学研究理事会。
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