临床试验/NCT02912117

NCT02912117已完成不适用

Determining the Etiologic Diagnosis in Febrile Neutropenia Using the Karius Sequencing-based Infectious Disease Diagnostic Assay

Karius, Inc.1 个研究点分布在 1 个国家目标入组 57 人开始时间: 2016年8月最近更新: 2018年5月11日

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: 57
试验地点: 1
主要终点: Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis

研究概览研究设计入排标准结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

Prospective, observational study at Stanford University Hospital comparing the Karius Infectious Disease Diagnostic Sequencing Assay to the Final Microbiologic Diagnosis in Patients with Fever and Neutropenia.

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 of age
•Are or will be admitted to Stanford University Hospital for fever and neutropenia
•Neutropenia - an absolute neutrophil count of <500 per cubic mm
•Documented fever or report of fever ≥38.3 or ≥38.0 on two episodes separated by at least one hour, resulting in hospitalization for febrile neutropenia

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 Infectious Disease Diagnostic Sequencing Assay compared with standard clinical diagnosis

时间窗: 12 Months

次要结局

未报告次要终点

研究者

发起方

Karius, Inc.

申办方类型

Industry

责任方

Sponsor

研究点 (1)

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