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临床试验/NCT04147975
NCT04147975Unknown不适用

Assessment of Assay for Rapid Identification of Bloodstream Infections From Whole Blood

HelixBind, Inc.1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2019年10月1日最近更新:
适应症

试验速览

阶段
不适用
入组人数
225
试验地点
1
主要终点
Sensitivity and Specificity compared to Blood Culture (comparator method)

研究概览

简要总结

The purpose of this study is to assess the effectiveness of RaPID/BSI by testing its performance compared to blood cultures collected prospectively from consented subjects.

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

入选标准

  • Determined to have a positive blood culture.

排除标准

  • 未提供

结局指标

主要结局

Sensitivity and Specificity compared to Blood Culture (comparator method)

时间窗: Up to 24 hours following blood collection

The primary endpoint of sensitivity (detection of on panel pathogen) and specificity will be determined by comparing blood culture results with the RaPID/BSI results from the prospective clinical specimens.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (1)

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