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Post TB Sequelae Study

NCT06744179 · Status: ENROLLING_BY_INVITATION · Type: OBSERVATIONAL · Enrollment: 600

Last updated 2024-12-20

No results posted yet for this study

Summary

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.

Conditions

  • Tuberculosis, Pulmonary

Interventions

DIAGNOSTIC_TEST

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

Participants from both exposed and non-exposed groups will be assessed using different standardized questionnaire and a number of investigations to identify any cardiac and pulmonary complications over time. Individuals will be matched for age and sex to ensure comparability. This study aims to evaluate these complications and analyze any significant differences between the groups over the defined follow-up period.

Sponsors & Collaborators

  • International Centre for Diarrhoeal Disease Research, Bangladesh

    lead OTHER

Eligibility

Min Age
6 Months
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2024-07-07
Primary Completion
2027-06-07
Completion
2027-09-30

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06744179 on ClinicalTrials.gov