Childhood TB Sequel

Sponsor

London School of Hygiene and Tropical Medicine (Other)

Overall Status

Recruiting

CT.gov ID

NCT05325125

Collaborator

European and Developing Countries Clinical Trials Partnership (EDCTP) (Other)

100

Enrollment

Location

20.1

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief 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. We 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. Estimated date of last participant enrolled is December 2022.

Condition or Disease	Intervention/Treatment	Phase
Tuberculosis, Pulmonary

Study Design

Study Type:

Observational

Anticipated Enrollment :

100 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Evaluating the Sequelae of Pulmonary Tuberculosis in Gambian Children

Actual Study Start Date :

Mar 29, 2022

Anticipated Primary Completion Date :

Dec 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Children who have completed treatment for Tuberculosis Children < 18 years, who had drug sensitive pulmonary tuberculosis, either bacteriologically confirmed or not and who have completed treatment within the preceding 1 month before enrolment

Outcome Measures

Primary Outcome Measures

Self- or parent-reported respiratory symptoms [6 months and 12 months after enrolment]
Derived from the St George's Respiratory Questionnaire and classified as 'improvement', 'no change' or 'deterioration'
Lung function measured by spirometry [6 months and 12 months after enrolment]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

N/A to 18 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Aged less than 18 years
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 a 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	MRCG at LSHTM	Fajara		Gambia

Sponsors and Collaborators

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

Investigators

Principal Investigator: Esin Nkereuwem, MBBCh, MSc, MRCG at LSHTM

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

London School of Hygiene and Tropical Medicine

ClinicalTrials.gov Identifier:

NCT05325125

Other Study ID Numbers:

22613

First Posted:

Apr 13, 2022

Last Update Posted:

Apr 13, 2022

Last Verified:

Apr 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Undecided

Plan to Share IPD:

Undecided

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Tuberculosis

Tuberculosis, Pulmonary

Study Results

No Results Posted as of Apr 13, 2022