NCT02477683已完成不适用
Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,514
- 试验地点
- 6
- 主要终点
- Utility of multiplexed testing for pathogens in pediatric patients with acute fever
研究概览
简要总结
The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.
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
- — 至 3 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •under age of 3
- •has fever with no obvious focal infection
- •written informed parental permission
排除标准
- •parent/legal guardian unable to provide permission
- •participation determined by a physician to be detrimental to patient health
结局指标
主要结局
Utility of multiplexed testing for pathogens in pediatric patients with acute fever
时间窗: 15 months
次要结局
- Epidemiology of pathogens in pediatric patients with acute fever(15 Months)
研究者
研究点 (6)
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