Next-Generation-Sequencing Approach to Neutropenic Sepsis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 6
- 主要终点
- Evaluation of the performance of a NGS-based
研究概览
简要总结
The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER in neutropenic patients with FN is to provide further evidence of the efficacy of an NGS-based approach for detecting bloodstream infection in neutropenic patients.
详细描述
The aim of this prospective, observational, non-interventional, multi-centre study of the diagnostic use of DISQVER (Platform for digital pathogen diagnostics from Noscendo GmbH) in neutropenic patients with FN (Febrile neutropenia) is to provide further evidence of the efficacy of an NGS (Next-generation seqzencing)-based approach for detecting bloodstream infection in neutropenic patients.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥18 years
- •Informed consent
- •Neutropenia defined as <500 ANC (Absolute neutrophil Count)/µl or <1000 WBC (White bloddcell Count)/µl if ANC is not available
- •Fever (with an onset < 24h) or Sepsis (with an onset <24h) Patients with a life-threatening - organ dysfunction caused by a dysregulated host response to a suspected or proven infection.
排除标准
- •Age < 18 years
- •Refusal or inability to give consent Inability to give informed consent if no acceptable patient representative is available
- •Patients who had previously been included, but develop a new episode of fever during the same hospitalization, will not be included a second time
- •Death is deemed imminent and inevitable
结局指标
主要结局
Evaluation of the performance of a NGS-based
时间窗: Baseline
Number of Participants with detection of pathogen
次要结局
- Average process time for NGS-based measurements(Baseline)
研究者
Boris Böll
Principal Investigator, Clinical Professor
University Hospital of Cologne