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临床试验/NCT05325125
NCT05325125招募中不适用

Evaluating the Sequelae of Pulmonary Tuberculosis in Gambian Children

London School of Hygiene and Tropical Medicine1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2022年3月29日最近更新:
适应症

试验速览

阶段
不适用
状态
招募中
入组人数
100
试验地点
1
主要终点
Change in self- or parent-reported respiratory symptoms

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 19 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • 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

排除标准

  • 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

结局指标

主要结局

Change in self- or parent-reported respiratory symptoms

时间窗: 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

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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