Long-term effects of childhood pulmonary tuberculosis
Evaluating the Sequelae of Pulmonary Tuberculosis in Gambian Children
London School of Hygiene and Tropical Medicine · NCT05325125
This study looks at how childhood pulmonary tuberculosis affects kids in the long run by checking their health and lung function after they finish treatment.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 100 (estimated) |
| Ages | N/A to 19 Years |
| Sex | All |
| Sponsor | London School of Hygiene and Tropical Medicine (other) |
| Locations | 1 site (Fajara) |
| Trial ID | NCT05325125 on ClinicalTrials.gov |
What this trial studies
This observational study aims to investigate the long-term adverse outcomes associated with pulmonary tuberculosis (PTB) in children. It will involve a prospective cohort of children who have completed treatment for PTB, assessing their clinical status, lung function through spirometry, and radiographic changes over a 36-month period. The study seeks to identify epidemiological risk factors linked to these long-term sequelae, addressing a significant gap in current knowledge regarding the chronic impacts of PTB in pediatric populations.
Who should consider this trial
Good fit: Ideal candidates for this study are children aged 19 years and below who have completed treatment for pulmonary tuberculosis and reside in the Greater Banjul Area.
Not a fit: Patients who relocate from the study area during the follow-up period or develop tuberculosis disease during the follow-up will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide critical insights into the long-term health impacts of childhood PTB, potentially guiding future treatment and management strategies.
How similar studies have performed: While there is limited published data specifically on long-term outcomes in children with PTB, studies in adults have shown significant long-term pulmonary impairment, suggesting that this area of research is both novel and necessary.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Aged 19 years and below * Reside in the Greater Banjul Area * Were diagnosed with either confirmed or unconfirmed PTB * Have completed treatment with an outcome of 'cured' or 'treatment completed' according to the Gambia NLTP guideline * Parent/caregiver willing to provide written informed consent, as well as assent for the children Exclusion Criteria: * Relocate from the study area during the follow-up period. If they are reachable by telephone, they will be excluded from study visits in the clinic but will continue to be followed up via telephone calls * Develop tuberculosis disease during the follow-up period
Where this trial is running
Fajara
- MRCG at LSHTM — Fajara, Gambia (RECRUITING)
Study contacts
- Principal investigator: Esin Nkereuwem, MBBCh, MSc — MRCG at LSHTM
- Study coordinator: Esin Nkereuwem, MBBCh, MSc
- Email: esin.nkereuwem@lshtm.ac.uk
- Phone: +2204495835
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Tuberculosis, Pulmonary