Shotgun Sequencing for Etiologic Diagnosis of Febrile Neutropenia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Number and frequency of novel pathogens found
研究概览
简要总结
This research trial studies the shotgun sequencing of blood samples in diagnosing febrile neutropenia in patients with acute myeloid leukemia. Studying samples of blood from patients with acute myeloid leukemia in the laboratory may help identify pathogens and accurately diagnose infections such as febrile neutropenia.
详细描述
PRIMARY OBJECTIVES:
I. To test the hypothesis that shotgun metagenomics is not inferior to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.
SECONDARY OBJECTIVES:
I. To establish a microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis.
OUTLINE:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 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
- •Patients with febrile neutropenia
- •A primary diagnosis of acute myeloid leukemia (AML)
排除标准
- •Prior history of febrile neutropenia
结局指标
主要结局
Number and frequency of novel pathogens found
时间窗: Up to 6 weeks
Detection of pathogens in patients with febrile neutropenia assessed by shotgun metagenomics
时间窗: Up to 6 weeks
Will be compared to standard of care diagnostics in the detection of pathogens in patients with febrile neutropenia.
Proportion of patients with any pathogen by the standard, where the shotgun did not indicate the presence of the pathogen
时间窗: Up to 6 weeks
Proportion of patients with false positives
时间窗: Up to 6 weeks
Proportion of patients with false negative
时间窗: Up to 6 weeks
Proportion of patients with mitochondrial DNA detected
时间窗: Up to 6 weeks
次要结局
- Microbiological diagnosis with known or unknown pathogens in patients in whom standard care failed to yield a pathogenic diagnosis assessed by shotgun metagenomics(Up to 6 weeks)