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临床试验/NCT03025802
NCT03025802已完成不适用

Fast Assay for Pathogen Identification and Characterization - Prospective Study

Hasselt University2 个研究点 分布在 2 个国家目标入组 238 人开始时间: 2017年1月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
238
试验地点
2
主要终点
Detection of pathogens and its virulence factors and susceptibility genes

研究概览

简要总结

The FAPIC project will develop a diagnostic system that will identify pathogens and charachterize virulence and resistance. A prospective study will be performed in which blood samples will be collected of patients with suspected sepsis in order to evaluate the diagnostic system. In routine care, blood is drawn of these patients for culture in order to identify the causative pathogen. This process takes 3-5 days. During the study, one extra blood sample will be collected with the same venipuncture, with each blood culture. Afterwards, routine diagnosis by blood culture is followed. Blood samples will be send to the research laboratories for determination of sensitivity and specificity. The system will not be used in the clinic.

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

  • •Older than 18 years
  • •Suspicion of bacteremia

排除标准

  • •Children (<18 years)

结局指标

主要结局

Detection of pathogens and its virulence factors and susceptibility genes

时间窗: 1 year

Sensitivity, specificity, and accuracy of the molecular system compared to blood culture.

次要结局

  • Population outcome during routine procedures(1 year)

研究者

发起方
Hasselt University
申办方类型
Other
责任方
Principal Investigator
主要研究者

prof. dr. Inge Gyssens

Prof. dr.

Hasselt University

研究点 (2)

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