Improving the Diagnosis and Management of Latent Tuberculosis in Thai Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 158
- 试验地点
- 2
研究概览
简要总结
The study is a prospective study to improve the diagnosis and management of latent TB in HIV-infected and HIV uninfected children in Thailand. The objectives are to assess the sensitivity and specificity of IGRAs (T-Spot®.TB, a T-cell-based assay, and QuantiFERON®-TB Gold In-tube, a whole blood assay), TST, and a refined symptom-based questionnaire in diagnosing latent TB in 166 HIV-infected and HIV uninfected children in Thailand, and to evaluate the influence of age, nutritional and immune status on children's response to the IGRAs. These children will be screened for TB with a detailed TB contact history, symptom-based questionnaire, physical examination, TST, chest radiograph (and abdominal ultrasound for those with abdominal symptoms), IGRAs, and clinical specimens for acid fast bacilli stain and culture. A diagnostic algorithm will be generated using the combination of test modalities with the highest sensitivity and specificity results.
详细描述
Study Objectives
- To compare the utility of IGRAs, T-Spot®.TB and QuantiFERON®-TB Gold In-Tube, and TST for screening of latent TB in HIV-infected children
- To compare these different screening modalities in HIV-infected children to HIV uninfected children
- To assess the influence of age, nutritional and immune status, prior BCG and TST status on children's response to IGRAs
- To assess the prognostic value of IGRAs vs. TST in predicting development of active TB in children over 9 months
Research questions:
Primary:
What is the sensitivity and specificity of IGRAs and TST in screening for latent TB in HIV-infected and HIV uninfected children in Thailand?
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
- 2 Months 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Have close contact with a person > 15 years of age who had active pulmonary (± extrapulmonary), sputum AFB positive TB (household member or non-household member with contact > 120 hours/month) during the past year
- •Are between the ages of 2 months and 16 years
- •Parents or caregivers provide informed consent to participate
- •Provide child assent for children aged ≥ 7 years
排除标准
- •Child and/or parent/caregiver who refuse study participation
- •Are currently receiving antituberculosis medications for TB disease
- •Have recently been diagnosed with active TB within past 6 months
研究者
Hong Van Tieu
Co-investigator
Columbia University