Tuberculosis, PulmonaryNCT05325125
Childhood TB Sequel
An observational study of Tuberculosis, Pulmonary, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
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. Read more about this study
- Who is it for?
- Ages Up to 19 years
- Conditions the study is for
- Tuberculosis, Pulmonary
- How many people
- 100 participants
- Where
- 1 siteThe Gambia
- Study dates
- 29 Mar 2022to Jun 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 19 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The prevalence of TB in The Gambia is estimated to be 128 per 100,000 population, with children comprising about 8% of all notified cases annually. Over 70% of all cases of TB notified in the country reside in the GBA. The study population will comprise children and adolescents (aged 19 years and below) who are in the final month of their treatment for PTB. They will be identified for possible inclusion in the study at any of the Gambia National Leprosy and Tuberculosis Programme (NLTP) treatment clinics in the GBA. At the completion of PTB treatment, eligible children will be invited to the MRCG at LSHTM Childhood TB research clinic for formal enrolment.
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
The Gambia1 site, 1 recruiting
- Recruiting
MRCG at LSHTM
Fajara
Esin Nkereuwem, +2204495835 ext. 3029, esin.nkereuwem@lshtm.ac.uk
About this study
Official title: Evaluating the Sequelae of Pulmonary Tuberculosis in Gambian Children
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.
Read the detailed 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.
- Conditions
- Tuberculosis, Pulmonary
- Medical subject headings
- Tuberculosis, Pulmonary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Children who have completed treatment for Tuberculosis | Children 19 years and below who had drug-sensitive pulmonary tuberculosis, either bacteriologically confirmed or not and who have completed treatment within the preceding 6 weeks before enrolment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in self- or parent-reported respiratory symptoms
Derived from the St George's Respiratory Questionnaire and classified as 'improvement', 'no change' or 'deterioration'
Measured: 6 months and 12 months after enrolment
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.
Measured: 6 months and 12 months after enrolment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2022
- Study start29 Mar 2022
- Primary completionJun 2024 (estimated)
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Tuberculosis, PulmonaryStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Responsible party
- Sponsor
- Investigators
- Esin Nkereuwem, MBBCh, MSc, Principal investigator, MRCG at LSHTM
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05325125
- Sponsor's protocol ID
- 22613
- Status last verified
- Sep 2023
- First submitted
- 5 Apr 2022
- Last updated
- 13 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Nkereuwem E, Agbla S, Jatta ML, Masterton U, Owolabi O, Edem VF, Kampmann B, Togun T. Childhood TB sequel: evaluating respiratory function after treatment for pulmonary tuberculosis in a prospective cohort of Gambian children - a study protocol. BMC Pulm Med. 2023 Oct 12;23(1):387. doi: 10.1186/s12890-023-02659-2.
PubMed 37828470
Study at a glance
From the registry record, last updated by the sponsor on 13 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Sequelae of Pulmonary Tuberculosis in Gambian Children
- ClinicalTrials.gov ID
- NCT05325125
- Acronym / sponsor ID
- 22613
- Conditions
- Tuberculosis, Pulmonary
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- European and Developing Countries Clinical Trials Partnership (EDCTP)
- Study start
- 29 Mar 2022 (actual)
- Primary completion
- Jun 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 13 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Children who have completed treatment for Tuberculosis | – | –Children 19 years and below who had drug-sensitive pulmonary tuberculosis, either bacteriologically confirmed or not and who have completed treatment within the preceding 6 weeks before enrolment |
Who may qualify
- Ages
- Up to 19 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The prevalence of TB in The Gambia is estimated to be 128 per 100,000 population, with children comprising about 8% of all notified cases annually. Over 70% of all cases of TB notified in the country reside in the GBA. The study population will comprise children and adolescents (aged 19 years and below) who are in the final month of their treatment for PTB. They will be identified for possible inclusion in the study at any of the Gambia National Leprosy and Tuberculosis Programme (NLTP) treatment clinics in the GBA. At the completion of PTB treatment, eligible children will be invited to the MRCG at LSHTM Childhood TB research clinic for formal enrolment.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change in self- or parent-reported respiratory symptoms
Time frame: 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
Time frame: 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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Sep 2023.
- Derived from this study: PubMed 37828470Nkereuwem E, Agbla S, Jatta ML, Masterton U, Owolabi O, Edem VF, Kampmann B, Togun T. Childhood TB sequel: evaluating respiratory function after treatment for pulmonary tuberculosis in a prospective cohort of Gambian children - a study protocol. BMC Pulm Med. 2023 Oct 12;23(1):387. doi: 10.1186/s12890-023-02659-2.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Esin Nkereuwem, MBBCh, MSc principal investigator
MRCG at LSHTM
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Tuberculosis, Pulmonary, run by London School of Hygiene and Tropical Medicine at 1 site in The Gambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 13 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in The Gambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Esin Nkereuwem, MBBCh, MSc (+2204495835 ext. 3029, esin.nkereuwem@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in self- or parent-reported respiratory symptoms (time frame: 6 months and 12 months after enrolment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05325125, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Sep 2023.