A Rapid Test for Acute Respiratory Illness
A Rapid Test for 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:

 1. Evaluate the effect of age on the performance of the HR-ARI test

 2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test

 3. Evaluate the effect of geography on the performance of the HR-ARI test
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:

 1. Evaluate the effect of age on the performance of the HR-ARI test

 2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test

 3. 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.
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.