Post TB Sequelae Study

Launched by INTERNATIONAL CENTRE FOR DIARRHOEAL DISEASE RESEARCH, BANGLADESH · Dec 19, 2024

Keywords

ClinConnect Summary

Understanding the Post-Intervention TB Sequelae in Patients After Completion of Standard TB Treatment

Introduction:

Tuberculosis (TB) is a chronic infectious disease caused by \*Mycobacterium tuberculosis\*. It primarily affects the lungs, though it can also involve other tissues. Despite remarkable advances in TB treatment, survivors face substantial health challenges. These include residual lung damage, persistent respiratory symptoms, cardiovascular complications, and even increased mortality risks. This protocol outlines a comprehensive longitudinal cohort study to investigate post-TB...

Gender

ALL

Eligibility criteria

• Inclusion Criteria for TB exposed group:
• • 1. Children and adolescents aged 6 months to 15 years; and participants aged \>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.