NCT03064100Unknown不适用
Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
适应症
试验速览
- 阶段
- 不适用
- 入组人数
- 1,500
- 试验地点
- 3
- 主要终点
- Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays)
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 CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 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 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture
- •Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity)
- •Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED)
- •Specimen is at least 500 µL (1.5 mL collection desired)
排除标准
- •Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity)
- •Physician determines that participation in the study is an unacceptable health risk
- •Minimum volume requirement is not met
结局指标
主要结局
Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays)
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (3)
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