Childhood TB Sequel

Tuberculosis, Pulmonary Clinical Trial

Official title:

Evaluating the Sequelae of Pulmonary Tuberculosis in Gambian Children

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05325125
• Other study ID #: 22613
• Status: Recruiting
• Start date: March 29, 2022
• Est. completion date: June 2024

Study information

• Verified date: September 2023
• Source: London School of Hygiene and Tropical Medicine
• Contact: Esin Nkereuwem, MBBCh, MSc
• Phone: +2204495835
• Email: esin.nkereuwem[@]lshtm.ac.uk
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study aims to describe the long-term adverse outcomes associated with PTB in children, to describe the evolution of these sequelae, and to determine the epidemiological risk factors associated with these sequelae. The investigators will conduct a prospective cohort study. Children who have completed treatment for PTB will be enrolled. The study visit will be performed in the study clinic, where clinical assessment, spirometry and radiography will be performed. The planned duration of the study is 36 months. Participant enrolment is estimated to begin in March 2022. The estimated date of the last participant enrolled is December 2022.

Description:

In the past, treatment success in TB has been defined as the eradication of active infection while preventing resistance. However, this definition of TB treatment outcome, which is based on clinical improvement and microbiological cure, is insufficient as it does not consider long-term outcomes such as loss of pulmonary function, which is medically relevant and possibly more frequent than we currently know. With the introduction of effective treatment for PTB, the international TB community has focused more on diagnostics and therapeutics to improve disease survival. However, unlike most respiratory infections, TB tends to leave the individuals' lungs permanently destroyed or damaged. Pulmonary TB thereby transitions from a treatable communicable disease into a chronic, non-communicable disease across the life course after apparently successful treatment. Although PTB accounts for at least 80% of the 1.2 million TB cases that occur in children, there is currently no published data about adverse health consequences and long-term impact of PTB, including changes in lung function, in children and adolescents who have completed TB treatment. However, long-term impairment in pulmonary function has been documented in more than half of the adult PTB survivors despite achieving a microbiological cure. Studies have also demonstrated that bacterial pneumonia in childhood significantly impairs the long-term function of the lungs, independent of what it was at baseline. Despite this, little is known about the changes in the pulmonary function of children after TB treatment completion, especially in low- and middle-income countries (LMIC) where the disease burden is high. The Childhood TB Sequel study hypothesises that early childhood PTB is likely to negatively impact an individual's attained lung function and hasten the rate of decline in adulthood. While this probable impact may be subclinical in childhood, detailed prospective paediatric data are urgently needed to establish the burden of post-TB lung disease (PTLD) in children using lung function measurements regardless of symptoms and social determinants for lung health. This study seeks to determine whether, among Gambian children and adolescents aged 19 years and below, PTB is associated with a reduction in pulmonary function measured by spirometry and an increase in the incidence of all-cause mortality. This study will include adolescents aged 15 to 19 years old who have a considerably high incidence of TB and are often neglected in childhood TB research.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 19 Years

Eligibility

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

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Pulmonary

Locations

Country	Name	City	State
Gambia	MRCG at LSHTM	Fajara

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	European and Developing Countries Clinical Trials Partnership (EDCTP)

Country where clinical trial is conducted

Gambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in self- or parent-reported respiratory symptoms	Derived from the St George's Respiratory Questionnaire and classified as 'improvement', 'no change' or 'deterioration'	6 months and 12 months after enrolment
Primary	Lung function measured by spirometry	The pattern of change over the 6-monthly intervals will be classified as 'improvement', 'no change' or 'deterioration' based on pre-defined minimal clinical important difference (MCID) cut-offs for the measured parameters.	6 months and 12 months after enrolment