Performance Assessment of High Throughput Sequencing for the Detection of Pathogens in Immunocompromised Patients With Suspected Infectious Disease.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pathoquest
- 入组人数
- 250
- 试验地点
- 2
- 主要终点
- Identification of pathogens responsible for the infection
研究概览
简要总结
The study patients are patients suffering from primary or secondary immunodeficiencies investigated in the Hospital Necker for a suspected infectious disease.
The study purpose is to assess the performance of a High Throughput Sequencing method, the PATHOQUEST method (from sample preparation to bio informatic analysis), versus the classic diagnostic approach.
The study will evaluate the capacity of the PATHOQUEST method to detect pathogens responsible for an infectious disease episode and will also evaluate the delay of obtention of results compared to the classic diagnostic approach.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 1 Year 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Identification of pathogens responsible for the infection
时间窗: 1 year
The primary outcome will assess the number of diagnostics obtained by the PATHOQUEST method and classic diagnostic approach.
次要结局
- Delay of obtention of diagnostic(1 year)
- Economic impact of the PATHOQUEST method(1 year)