Understanding the Post-intervention TB Sequelae in Patients After Completion of Standard TB Treatment
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 1
- 主要终点
- Understanding the post-intervention TB sequelae in patients after completion of standard TB treatment
研究概览
简要总结
The goal of this prospective cohort study is to learn about the long-term health effects of tuberculosis (TB) in children, adolescents, and adults who have completed standard TB treatment in Bangladesh. The study aims to track the evolution of pulmonary and cardiac sequelae within the first two years after TB treatment completion.
The main question it aims to answer is:
Does completing TB treatment result in long-term pulmonary or cardiac health issues (post-TB lung disease, PTLD) in patients compared to those without TB? Additionally, how does this impact children's growth, radiological patterns, and overall quality of life?
Participants who have completed anti-TB treatment for the first episode of pulmonary TB and non-TB participants (age- and sex-matched controls) will be followed for two years. The study will take place at multiple sites in Dhaka, including icddr,b Tuberculosis Screening & Treatment Centers (TBSTC) and Dhaka Shishu Hospital. TB patients and controls will be recruited from Dhaka and surrounding areas.
Over a two-year period, participants will be followed at five key points: within 5-7 days of treatment completion (T0), at 6 months (T1), 12 months (T2), 18 months (T3), and 24 months (T4). Data collection will involve comprehensive clinical evaluations, pulmonary and cardiovascular examinations, laboratory tests, and diagnostic imaging such as chest X-rays, ECGs, and pulmonary function tests.
The study will address several key outcomes, including:
The prevalence and incidence of post-TB lung disease and cardiac sequelae Weight gain and growth in children post-treatment Radiological and ECG patterns post-treatment Mental health and quality of life following TB recovery Associations between demographic, social, and lifestyle factors and post-TB sequelae Through this observational study, researchers hope to contribute valuable insights into the long-term health challenges faced by TB survivors, particularly among children, for whom such data is currently lacking.
详细描述
Understanding the Post-Intervention TB Sequelae in Patients After Completion of Standard TB Treatment
Introduction:
Tuberculosis (TB) is a chronic infectious disease caused by *Mycobacterium tuberculosis*. It primarily affects the lungs, though it can also involve other tissues. Despite remarkable advances in TB treatment, survivors face substantial health challenges. These include residual lung damage, persistent respiratory symptoms, cardiovascular complications, and even increased mortality risks. This protocol outlines a comprehensive longitudinal cohort study to investigate post-TB sequelae-a critical and under-researched area-focusing on the long-term pulmonary and cardiac health outcomes of TB survivors.
Bangladesh is one of the high TB-burden countries globally, with an incidence rate of 221 cases per 100,000 population and a TB mortality rate of 24 per 100,000 population. Approximately 80% of TB cases in the country are pulmonary TB. The significant burden of TB in Bangladesh underscores the importance of investigating its long-term sequelae to guide health policies and improve patient care.
This study aims to fill critical knowledge gaps, particularly concerning pediatric post-TB health outcomes, by evaluating a cohort of individuals who have completed TB treatment and comparing them with non-TB-exposed counterparts. The study will also assess quality of life, growth in children, and associated mental health outcomes over two years.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 6 Months 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Understanding the post-intervention TB sequelae in patients after completion of standard TB treatment
时间窗: Participants is enrolled within 5-7 days of TB treatment completion (T0) and follow-up is done at five time points: at 6 months (T1), 12 months (T2), 18 months (T3), and 24 months (T4)
The primary end point will be the prevalence of Post TB Lung Disease (PTLD) among young children, older children and adults. We will define Post TB sequelae or PTLD as evidence of one or more chronic respiratory abnormality attributable at least in part to previous PTB or pleural TB, such as, chronic cough (persistent cough that lasts ≥8 weeks on some or most days); dyspnoea using the modified Medical Research Council (mMRC) dyspnoea scale; hypoxaemia (SpO2 \<90% in room air); abnormal lung function test, and abnormal radiology findings after completion of TB treatment.
次要结局
未报告次要终点