A Multicentre, Cohort Study of Screening and Preventive Intervention for Latent Tuberculosis Infection in Children
试验速览
- 阶段
- 1 期
- 发起方
- 入组人数
- 1,000
- 试验地点
- 1
- 主要终点
- Proportion of adverse reactions
研究概览
简要总结
The management of latent Mycobacterium tuberculosis infection is a new priority action for the WHO End Tuberculosis (TB) Strategy. However, national guidelines on latent tuberculosis infection testing and treatment have not yet been developed in children of China. Here, we present the results from the 3-year follow-up of a study that aimed to track the development of active disease in individuals with latent tuberculosis infection, identify priority populations for latent infection management, and explore the most suitable latent infection diagnostic approach.
详细描述
-
Baseline analysis of a population-based, multicentre, prospective cohort study
-
A baseline survey of a population-based, multicentre, prospective cohort study were took in children (≤18).
-
Eligible participants were identifi ed by door-to-door survey with a household sampling design.
-
Participants were screened for active tuberculosis and history of tuberculosis then used a tuberculin skin test and an interferon-γ release assay (QuantiFERON [QFT]) to test for latent infection.
-
Incidence of active tuberculosis in individuals with latent tuberculosis infection in children of China under different treatment regimens
-
Individuals who had tuberculosis infection at baseline (QFT-positivity or TST tuberculin reaction size [induration] of ≥10 mm) were divided and treatment with different therapeutic schedule.
-
Follow-up study were conducted to assess the proportion of latent TB infection converted to active TB
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 1 Day 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Children (0-18 years old).
- •Children with QFT-positive or TST induration ≥10 mm).
排除标准
- •Patients are allergic to anti-tuberculsis drugs.
- •Parents and/or guardians do not agree to participate in this study.
- •Participants with active tuberculosis.
研究组 & 干预措施
6INH Group
10mg/kg 6INH were used in this group.
干预措施: INH、RFT (Drug)
3INH+RFT group
3INH+RFTwere used in this grroup.
干预措施: INH、RFT (Drug)
结局指标
主要结局
Proportion of adverse reactions
时间窗: During the 2 year follow-up study
The incidence of adverse reactions in different treatment regimens
Proportion of lost to follow-up
时间窗: During the 2 year follow-up study
The proportion of lost to follow-up in different treatment regimens
Morbidity
时间窗: During the 2 year follow-up study
Percentage of latent TB infections converted to active TB
次要结局
未报告次要终点
研究者
Adong Shen
Deputy Chief of China National Clinical Research Center for Respiratory Diseases
Beijing Children's Hospital