跳至主要内容
临床试验/CTRI/2021/04/032509
CTRI/2021/04/032509尚未招募不适用

Evaluation of Truenat and CBNAAT for detection of Tubercular Meningitis in children and adolescents.

Department of Pediatrics1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2021年10月4日最近更新:

试验速览

阶段
不适用
状态
尚未招募
入组人数
70
试验地点
1
主要终点
Cohens kappa coefficient to find out the degree of reliability between MTB detection by Truenat and CBNAAT in CSF samples.

研究概览

简要总结

This study is being conducted to evaluate the role of Truenat vs CBNAAT for the diagnosis of Tubercular Meningitis in children and adolescents.

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

  • Suspected case of Tubercular Meningitis13 as evidenced by: Fever >5days, weight loss, anorexia along with neurological signs and symptoms (headache, vomiting, irritability, lethargy, seizures, confusion, coma, neck stiffness, cranial nerve palsy, hemiparesis) and CSF showing presence of 10-500 WBC/mm3, lymphocytes >50% and CSF/Plasma glucose <50% and WBC in blood <15x109/lt And/or imaging with evidence of basal meningeal enhancement, hydrocephalous or cerebral infarct or tuberculoma.

排除标准

  • 未提供

结局指标

主要结局

Cohens kappa coefficient to find out the degree of reliability between MTB detection by Truenat and CBNAAT in CSF samples.

时间窗: 1 year

次要结局

  • Difference in proportions of positivity status of CBNAAT and Truenat with respect to severity of disease.

研究者

申办方类型
Government medical college

研究点 (1)

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