Impact of Rapid Flu Testing in BMC ED (FluProcess)
2018年7月23日 更新者：Elissa Schechter-Perkins、Boston Medical Center
Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center
The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory.
Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device.
The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time.
Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing
研究概览
研究类型
介入性
注册 (实际的)
233
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Massachusetts
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Boston、Massachusetts、美国、02118
- Boston University Medical Center
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
21年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Adult patients 21 years of age or older
- Presenting to the BMC main ED or Urgent Care area with influenza-like illness
- Physician ordered an influenza A/B diagnostic test
Exclusion Criteria:
- Previously enrolled in the study
- Any Influenza test result already available at the time approached by the ED RA
- Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
- Unable to give informed consent
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Core Lab Testing Arm
For patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays.
The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.).
Which test is ordered is at the discretion of the physician.
Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B.
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For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.
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实验性的：ED Point of Care Testing Arm
Prior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC.
The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm.
The Cobas Liat assay provides a result callout to distinguish influenza type A from type B.
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For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay
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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Time to Disposition
大体时间：By the End of the ED visit (an average time of 4 hours)
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The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record
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By the End of the ED visit (an average time of 4 hours)
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Delivery of prescription or administration of antibiotics
大体时间：by the end of ED visit (an average time of 4 hours)
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Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD
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by the end of ED visit (an average time of 4 hours)
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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Elissa Perkins, MD, MPH、Boston University
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年2月7日
初级完成 (实际的)
2017年12月1日
研究完成 (实际的)
2017年12月1日
研究注册日期
首次提交
2016年11月22日
首先提交符合 QC 标准的
2016年11月29日
首次发布 (估计)
2016年12月2日
研究记录更新
最后更新发布 (实际的)
2018年7月24日
上次提交的符合 QC 标准的更新
2018年7月23日
最后验证
2018年7月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.