NCT06744179Enrolling by invitation
Post TB Sequelae Study
Understanding the Post-intervention TB Sequelae in Patients After Completion of Standard TB Treatment
Source: ClinicalTrials.gov · Last updated 20 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Enrolling by invitation
- Study type
- Observational
- Enrollment
- 600 (estimated)
- First submitted
- 6 Oct 2024
- Start date
- 7 Jul 2024
- Primary completion date
- 7 Jun 2027
- Lead sponsor
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Diseases
- Tuberculosis
- NCT number
- NCT06744179
What you commit to
- Study type: Observational
- Planned participants: 600
- From 7 Jul 2024 to the primary completion date, 7 Jun 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Tuberculous meningitis, and isolated other extra-pulmonary TB (i.e no concomitant pulmonary TB, or pleural TB), multidrug resistant TB.
Other illness
- Past TB disease or anti-TB treatment within last 6 months.
- 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.
- Past TB disease or anti-TB treatment Any current or past (chronic) respiratory infection or disease.
- Documented asthma, COPD, heart failure diagnosed by medical personnel
Other
- Heavy smoker who consumes more than 20 pieces of cigarettes per day or ≥20 more pack-year.
- \*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.
- Documented pneumonia, bronchiolitis, bronchitis in last 3 weeks.
- 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.
Who the study is looking for
- 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.
- 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.
Age in the registry: 6 months to - · Sex: All · Accepts healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| icddrb Dhaka hospital, Nutrition research division Coordinator of this site? Confirm its status | Dhaka | Bangladesh | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.