Enhance Tuberculosis Diagnosis and Improve Linkage to TB treatment in Indian Children
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,700
- 试验地点
- 3
- 主要终点
- Proportion of stool and tongue swab CBNAAT and Truenat positive among the presumptive TB children and Proportion of stool and tongue swab Xpert Ultra and Truenat Plus positive among the presumptive TB children
研究概览
简要总结
This study is an observational study with an aim to explore concurrence between standard methods and alternative methods to improve paediatric TB diagnosis through use of NAAT molecular diagnostic testing such as stool and tongue swab
Child friendly samples i e stool and tongue swab samples will be tested using Xpert MTB/RIF Ultra to compare its performance with routine national diagnostic procedures As well stool and tongue swab samples will be tested by Truenat MTB Plus to determine non-inferiority in terms of sensitivity and specificity compared to Xpert MTB/RIF Ultra
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 0.00 Day(s) 至 18.00 Year(s)（—）
- 性别
- All
入选标准
- •All children with presumptive TB up to and including 18 years of age whose parents consent to providing their children’s samples for enhanced diagnosis during the designated project activity period.
排除标准
- •Children who received anti tubercular therapy (ATT) including second line drugs for more than 72 hours.
结局指标
主要结局
Proportion of stool and tongue swab CBNAAT and Truenat positive among the presumptive TB children and Proportion of stool and tongue swab Xpert Ultra and Truenat Plus positive among the presumptive TB children
时间窗: 1 year
次要结局
- c. Sensitivity and specificity of stool and tongue swab for detection of TB among the presumptive TB children considering Mycobacterium Growth Indicator tube (MGIT) liquid culture as gold standard.(15 months)
研究者
Dr Sanjay Kumar Mattoo MD DTCD
Central TB Division Government of India