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NCT06744179

Post TB Sequelae Study

ENROLLING BY INVITATION Last updated 20 December 2024
What this trial tests

trial testing echocardiography, chest x-ray, full blood count , SGPT, lipid profile, HbA1C, AQ20 questionnaire, mmRC dyspnoea scale, Duke activity status index, COPD assessment test, Age and stage questionnaire in Tuberculosis, Pulmonary in 600 participants. Enrolling by invitation.

Timeline
7 July 2024
Primary endpoint
7 June 2027
30 September 2027

Quick facts

Lead sponsorInternational Centre for Diarrhoeal Disease Research, Bangladesh
StatusENROLLING BY INVITATION
Study typeOBSERVATIONAL
Enrollment600
Start date7 July 2024
Primary completion7 June 2027
Estimated completion30 September 2027
Sites1 location across Bangladesh

Drugs / interventions tested

Conditions studied

Sponsor

International Centre for Diarrhoeal Disease Research, Bangladesh — full company profile →

Who can join

6 Months and older, any sex, with Tuberculosis, Pulmonary. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.

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Other recruiting trials for Tuberculosis, Pulmonary

Currently open trials in the same condition.

Other International Centre for Diarrhoeal Disease Research, Bangladesh trials

Trials by the same sponsor.

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Data sources for this page

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