A Rapid Test for Acute Respiratory Illness

Study Overview
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Brief Summary
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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

Detailed Description
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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.

Official Title
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Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness

Conditions
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Bacterial Infections, Virus Disease, Respiratory Tract Infection Acute, Transcriptome

Intervention / Treatment
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* Diagnostic Test: Host Gene Expression


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Subjects with Acute Respiratory Illness<br>Patients with acute respiratory illness identified in the Emergency Department | Diagnostic Test: Host Gene Expression<br>* comparison to retrospective clinical adjudication<br>* Other names: Adjudication;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value with reference standard (PPV) | 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] | Day 1 | 
| Negative predictive value with the reference standard (NPV) | 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] | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall agreement with the reference standard (OA) | Number of samples that agree with the reference standard / all samples tested | Day 1 |