Post TB Sequelae Study

NCT06744179 | Enrolling By Invitation DMC

• 1 other identifier: PR-24005
• Study Type: observational
• Target: 600
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Understanding the post-intervention TB sequelae in patients after completion of standard TB treatment

  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.

  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)

Study Arms (1)

Exposed to pulmonary TB and Not exposed to pulmonary TB

we will enroll a group of individuals exposed to TB who have completed standard TB treatment (e.g., 6-9 months of anti-TB therapy). Simultaneously, we will recruit matched individuals without a history of TB from the same population to form the unexposed group. We will recruit post TB patients and age and sex-matched TB unexposed participants in a 1:1 ratio. We will enrol the unexposed group to compare post-TB sequelae data of study TB patients with that of a local non-TB population. Consequently, we will enrol 210 adult pulmonary TB cases and 90 child TB cases. Similarly, 210 adults and 90 children without TB disease will be included as the unexposed group.

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

Interventions

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 DIAGNOSTIC_TEST

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.

Exposed to pulmonary TB and Not exposed to pulmonary TB

Eligibility Criteria

• Age: 6 Months+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Study participants will be recruited through icddr,b Tuberculosis Screening \& Treatment Centers (TBSTC) in Dhaka, where TB patients were referred for diagnosis and treatment initiation. Participants will be enrolled from seven TBSTCs in Mohakhali, Golapbagh, Dhanmondi, Uttara, Rampura, Mirpur, and Old Dhaka. These centers are managed by icddr,b under the National Tuberculosis Program (NTP) of Bangladesh. Additionally, child TB cases will be enrolled from Dhaka Shishu Hospital and icddr,b\'s Dhaka Hospital. Screening will occur during participants\' monthly medication collection visits, with formal recruitment at the end of their TB treatment. To compare post-TB sequelae, age and sex-matched participants without TB exposure will be recruited from the same or neighboring households of study TB patients to serve as controls, allowing comparison of post-TB outcomes with the local non-TB population.

You may qualify if:

• Children and adolescents aged 6 months to 15 years; and participants aged \>15 years and above.
• 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.
• Residing within Dhaka city and be willing to come for follow-up visits.(21)
• Provide consent for participation to the study.

You may not qualify if:

• Past TB disease or anti-TB treatment within last 6 months.
• Tuberculous meningitis, and isolated other extra-pulmonary TB (i.e no concomitant pulmonary TB, or pleural TB), multidrug resistant TB.
• Participants getting immunosuppressive therapy or other chemotherapy for malignancy.
• Pre-existing mental illness. Participants with preexisting mental illness will be identified based on documented prescriptions or medical records provided by a qualified physician.
• 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.
• Heavy smoker who consumes more than 20 pieces of cigarettes per day or ≥20 more pack-year.
• 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.
• \*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.

Sponsors & Collaborators

• International Centre for Diarrhoeal Disease Research, Bangladesh: lead

Study Sites (1)

icddrb Dhaka hospital, Nutrition research division

Dhaka, Dhaka Division, 1212, Bangladesh

Location

MeSH Terms

Conditions

Tuberculosis, Pulmonary

Interventions

Echocardiography; Diagnostic Imaging; Blood Cell Count; Aging

Condition Hierarchy (Ancestors)

Tuberculosis; Mycobacterium Infections; Actinomycetales Infections; Gram-Positive Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Respiratory Tract Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Cardiac Imaging Techniques; Diagnostic Techniques and Procedures; Diagnosis; Ultrasonography; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Growth and Development; Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 42 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 6, 2024
• First Posted: December 20, 2024
• Study Start: July 7, 2024
• Primary Completion (Estimated): June 7, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: December 20, 2024

Record last verified: 2024-10

Locations

BA (1)