A Rapid Test for Acute Respiratory Illness (Radical)
Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
研究概览
详细说明
The primary purpose of this study is to support the development of a host response test for acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a clinical adjudication reference standard.
Secondary objectives include:
- Evaluate the effect of age on the performance of the HR-ARI test
- Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
- Evaluate the effect of geography on the performance of the HR-ARI test
Subjects will be identified in the Emergency Department of participating hospitals. Samples including nasopharyngeal swab, throat swab, blood, and urine will be obtained.
A case report form for each subject will be completed to include information regarding clinical characteristics, signs and symptoms of infection, presence of complications, and patient outcome. Baseline characteristics including preexisting conditions. Survival data will also be collected for each subject.
Samples collected will be used to characterize the patient's illness as either infectious or not, and if infectious, either bacterial or viral. Samples will also be used to measure changes in gene expression, referred to as the Host Response-Acute Respiratory Illness (HR-ARI) test.
The result of this test will be made in comparison to a retrospective review of the subject's clinical information. Results will not be used for any interventions and will not be released to subjects or their providers.
Because the study procedure includes only sample and data collection, the risks will be minimal and no different than encountered during routine clinical care.
The study was re-assessed in 2020 and applicable updates were made to the record.
研究类型
注册 (实际的)
联系人和位置
学习地点
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California
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Davis、California、美国、95616
- The University of California- Davis
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Massachusetts
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Boston、Massachusetts、美国、02115
- Brigham and Women's Hospital
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Newton、Massachusetts、美国、02462
- Newton-Wellesley Hospital
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Michigan
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Detroit、Michigan、美国、48202
- Henry Ford Hospital
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North Carolina
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Chapel Hill、North Carolina、美国、27514
- The University of North Carolina at Chapel Hill
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Durham、North Carolina、美国、27710
- Duke University Medical Center
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Pennsylvania
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Pittsburgh、Pennsylvania、美国、15224
- Children's Hospital of Pittsburgh
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Rhode Island
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Providence、Rhode Island、美国、02903
- Rhode Island/Lifespan
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Texas
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Houston、Texas、美国、77030
- The University of Texas- Houston
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Utah
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Salt Lake City、Utah、美国、84132
- University of Utah Medical Center
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
取样方法
研究人群
描述
Inclusion Criteria:
A. Age 24 months or older
B. Acute respiratory illness of less than 28 days in duration.
C. Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality:
- Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing
- Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius.
D. Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required.
Exclusion Criteria:
A. Known or suspected infection at any other anatomic site requiring antibacterial therapy.
B. Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial.
学习计划
研究是如何设计的？
设计细节
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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Subjects with Acute Respiratory Illness
Patients with acute respiratory illness identified in the Emergency Department
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comparison to retrospective clinical adjudication
其他名称：
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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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Positive predictive value with reference standard (PPV)
大体时间：Day 1
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Number of assay positives that agree with the reference standard / [Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard]
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Day 1
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Negative predictive value with the reference standard (NPV)
大体时间：Day 1
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Number of assay negatives that agree with the reference standard / [number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard]
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Day 1
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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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Overall agreement with the reference standard (OA)
大体时间：Day 1
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Number of samples that agree with the reference standard / all samples tested
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Day 1
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合作者和调查者
研究记录日期
研究主要日期
学习开始 (实际的)
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (实际的)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
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.
Host Gene Expression的临床试验
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Foundation for Innovative New Diagnostics, SwitzerlandUniversity of Witwatersrand, South Africa; PD Hinduja Hospital and Medical Research Centre,... 和其他合作者完全的
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National Institute for Medical Research, TanzaniaUniversity of Kinshasa (UNIKIN), Congo, The Democratic Republic of the ( Prof Vivi Maketa); Research... 和其他合作者尚未招聘
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University of North Carolina, Chapel HillCenters for Disease Control and Prevention完全的