NCT01734668已完成不适用
Sofia RSV FIA Field Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,468
- 试验地点
- 17
- 主要终点
- High level of sensitivity and specificity for performance vs. culture
研究概览
简要总结
The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of age.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female
- •Children less than nineteen (19) years of age can participate (assuming appropriate consent is obtained).
- •Must currently be exhibiting symptoms characteristic of respiratory syncytial virus (RSV) illness.
- •Subjects must present with one or more of the following to be eligible for enrollment:
- •Fever, ≥ 37.8º C (100º F) at present or within past 24 hours
- •Moderate to severe runny nose*
- •Moderate to severe congestion*
- •Decreased appetite
- •Sneezing*
- •Irritability
- •Decreased activity
- •Labored breathing
排除标准
- •Subjects nineteen years of age or older.
- •The parent or legal guardian is unable to understand and consent to participation.
- •Current or prior treatment during this infection with anti-RSV Synagis®.
结局指标
主要结局
High level of sensitivity and specificity for performance vs. culture
时间窗: Culture results within 48 hours of plating
Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.
次要结局
未报告次要终点
研究者
研究点 (17)
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