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ENROLLING BY INVITATION

NCT06744179

Post TB Sequelae Study

Sponsor: International Centre for Diarrhoeal Disease Research, Bangladesh

View on ClinicalTrials.gov

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.

Official title: Understanding the Post-intervention TB Sequelae in Patients After Completion of Standard TB Treatment

Key Details

Gender

All

Age Range

6 Months - Any

Study Type

OBSERVATIONAL

Enrollment

600

Start Date

2024-07-07

Completion Date

2027-09-30

Last Updated

2024-12-20

Healthy Volunteers

Yes

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.

Inclusion Criteria for TB exposed group: 1. Children and adolescents aged 6 months to 15 years; and participants aged \&gt;15 years and above. 2. Successful completion of anti-TB treatment for the first episode of pulmonary TB and or pleural TB, with cure or completion as defined by the NTP. 3. Residing within Dhaka city and be willing to come for follow-up visits.(21) 4. Provide consent for participation to the study. Exclusion Criteria for TB exposed group: 1. Past TB disease or anti-TB treatment within last 6 months. 2. Tuberculous meningitis, and isolated other extra-pulmonary TB (i.e no concomitant pulmonary TB, or pleural TB), multidrug resistant TB. 3. Participants getting immunosuppressive therapy or other chemotherapy for malignancy. 4. Pre-existing mental illness. Participants with preexisting mental illness will be identified based on documented prescriptions or medical records provided by a qualified physician. 5. Participants with known congenital heart disease, ischemic heart disease, cystic fibrosis. These participants will be identified based on documented prescriptions or medical records provided by a qualified physician. 6. Heavy smoker who consumes more than 20 pieces of cigarettes per day or ≥20 more pack-year. Inclusion Criteria of TB Unexposed group: age and sex-matched participants who do not have exposure to TB to compare post-TB sequelae data of study TB patients with that of a local non-TB population. Exclusion Criteria of TB Unexposed group: \*Patient will be excluded if any two symptoms or signs suggestive of TB is present according to the national guidelines for the management of TB in children and adult. Past TB disease or anti-TB treatment Any current or past (chronic) respiratory infection or disease. * Documented pneumonia, bronchiolitis, bronchitis in last 3 weeks. * Documented asthma, COPD, heart failure diagnosed by medical personnel * Documented general wheezing in chest (last 2 years) * Self-reported breathing difficulties during mild exercise, or at night. Heavy smoker who consumes more than 20 pieces per day or ≥20 more pack-year.

Locations (1)

icddrb Dhaka hospital, Nutrition research division

Dhaka, Dhaka Division, Bangladesh