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临床试验/NCT05149547
NCT05149547Unknown不适用

The Comparison of mNGS Versus Blood Culture for Early Diagnosis of Blood Stream Infection During the Febrile Neutropenia in Patients With Hematological Disease

Peking University People's Hospital1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2021年10月15日最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
diagnosis performance

研究概览

简要总结

Blood stream infection (BSI) during febrile neutropenia (FN) is a lethal complication, while confirmed diagnosis via blood culture is usually with low sensitivity and time delay. The new technique of metagenome next generation sequencing (mNGS) has the potential of early and more accurate detection of pathogens. However, this technique has not been well validated for BSI diagnosis in patients with hematological disease. Therefore, we designed a prospective multicenter study to compare the diagnosis performance in BSI.

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
15 Years 至 —(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • hematologic disease
  • febrile neutropenia

排除标准

  • refuse to consent
  • not caused by infection

结局指标

主要结局

diagnosis performance

时间窗: 14 days after sapmpling

the sensitivity and specificity of mNGS

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Xiao-Jun Huang

Head of Peking University Institute of Hematology

Peking University People's Hospital

研究点 (1)

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