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Post TB Sequelae Study

StatusEnrolling by Invitation
PhaseNot specified
Started
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Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT06744179
Lead Sponsor International Centre for Diarrhoeal Disease Research, Bangladesh
Conditions
(from sponsor)
Tuberculosis, Pulmonary
Related terms Tuberculosis, Pulmonary
Enrollment 600 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov