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临床试验/NCT02880384
NCT02880384已完成不适用

Projected Influence of Enhanced Pathogen Detection on the Clinical Management of Community-Acquired Pneumonia

Providence Health & Services1 个研究点 分布在 1 个国家目标入组 570 人开始时间: 2017年1月1日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
570
试验地点
1
主要终点
Pathogen Detection

研究概览

简要总结

Study to compare the number of community-acquired pneumonia (CAP) pathogens detected using current diagnostic tests to the number detected using the BioFire Diagnostics investigational polymerase chain reaction (PCR) platform.

详细描述

Patients diagnosed in the emergency department with CAP that requires hospitalization provide a sputum sample for culture and sensitivity testing, urine for detection of S. pneumonia and L. pneumophila, an anterior nasal swab for S. aureus PCR, a nasopharyngeal swab for S. pneumonia PCR and the FilmArray LRTI v.2.0 IUO Panel, and blood for procalcitonin testing and, in cases in which the patient is suffering rigors and hypotension, cultures. As part of this study, sputum or sputum equivalent will be acquired for testing using the FilmArray LRTI v.2.0 IUO Panel.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

性别
All
接受健康志愿者
否

入选标准

  • •Emergency Department physician diagnosis of CAP requiring hospitalization

排除标准

  • •Inability to obtain sputum or sputum equivalent

研究组 & 干预措施

FilmArray LRTI v.2.0 IUO Panel

Experimental

Patients will provide sputum or sputum equivalent for FilmArray LRTI v.2.0 IUO Panel testing.

干预措施: FilmArray LRTI v.2.0 IUO Panel (Other)

结局指标

主要结局

Pathogen Detection

时间窗: 5 Days

Compare the number of CAP pathogens detected using current diagnostic bundle to the number detected using the FilmArray LRTI v.2.0 IUO Panel.

次要结局

  • Treatment Influence(5 Days)
  • Nasopharyngeal swabs compared to sputum(5 Days)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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