Improved Diagnostics for Paediatric Tuberculosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To quantitate the speed of new culture method (TiKa) and compare its efficacy with conventional systems in detecting Mycobacterium tuberculosis in the faeces of paediatric patients with tuberculosis.
研究概览
简要总结
Improved diagnostics for paediatric Tuberculosis
详细描述
Research Question: To test the feasibility of TiKa system to reliably detect Mycobacterium tuberculosis in faeces of paediatric patients with Tuberculosis Study Design: Non-randomised diagnostic proof of concept feasibility study Study Participants: Patients with or suspected to have Tuberculosis
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- — 至 21 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any patient under the age of 21 years with the following diagnosis for whom informed consent can be obtained will be offered to be included in the trial.
- •Latent tuberculosis
- •Culture confirmed Tuberculosis
- •Clinically suspected Tuberculosis
排除标准
- •Any patient over 21
- •Any child or adult/guardian unable to give informed consent
- •Any persons under detention will not be included.
- •Any patient who is unable to give a sample.
结局指标
主要结局
To quantitate the speed of new culture method (TiKa) and compare its efficacy with conventional systems in detecting Mycobacterium tuberculosis in the faeces of paediatric patients with tuberculosis.
时间窗: 2 years
Samples will only include faeces (up to 10g) obtained once from outpatients and up to once per day for in-patients. Faecal samples will be collected and placed into a routine sterile stool collection kit, labelled with a unique identifier allocated from its associated CRF and safe transport arranged to deliver the specimen to the research laboratory. On arrival all samples will be logged and a record kept in a secure locked site by a member of the research team.
次要结局
未报告次要终点