Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 783
- 试验地点
- 10
- 主要终点
- Positive predictive value with reference standard (PPV)
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 2 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Positive predictive value with reference standard (PPV)
时间窗: Day 1
Number of assay positives that agree with the reference standard / \[Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard\]
Negative predictive value with the reference standard (NPV)
时间窗: Day 1
Number of assay negatives that agree with the reference standard / \[number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard\]
次要结局
- Overall agreement with the reference standard (OA)(Day 1)