NCT02988414已完成不适用
Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic 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
- 108
- 试验地点
- 1
- 主要终点
- Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia
研究概览
简要总结
Prospective study at Duke University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to blood culture results in admitted patients with bacteremia/septicemia.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
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
- •A positive blood culture
- •A suitable residual blood sample collected within 24 hours of the positive blood culture OR
- •A blood sample obtained for the study obtain within 48 hours of the positive blood culture
- •For Endocarditis Cohort:
- •All criteria above must be met and patient is admitted to the hospital and evaluated for acute endocarditis classified per the Duke Criteria
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
Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia
时间窗: 12 months
次要结局
未报告次要终点
研究者
研究点 (1)
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