NCT02730468已完成不适用
SEP-SEQ Trial - Determining the Etiology of Sepsis Using an Infectious Disease Diagnostic Sequencing Assay
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Karius, Inc.
- 入组人数
- 350
- 试验地点
- 1
- 主要终点
- Accuracy of sequencing assay in diagnosing etiology of sepsis
研究概览
简要总结
The purpose of this study is to evaluate the performance of the Karius Infectious Diseases Plasma Sequencing Assay in patients who present to the emergency room with sepsis.
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
- 否
入选标准
- •18 years or older
- •Meet 2 of 4 sepsis criteria
- •Temperature > 38C or < 36C
- •Heart rate > 90 bpm
- •Respiratory rate >20 or PaCO2 <32mmHg
- •WBC >12000/µL or < 4000/µL or > 10% bands
排除标准
- •Inability to understand instructions and comply with study-related procedures
- •Any condition that in the opinion of the treating physician will prevent the subject from completing the study.
结局指标
主要结局
Accuracy of sequencing assay in diagnosing etiology of sepsis
时间窗: 7 days
次要结局
未报告次要终点
研究者
研究点 (1)
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