A Rapid Test for Acute Respiratory Illness

Completed

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

In brief

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

Key facts

Study ID

NCT03192072

Run by

Duke University

People needed

783

Starts

2017-07-17

Expected to finish

2019-12-19

Last updated by the study team

2020-05-27

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• The University of California- Davis — Davis, California, United States
• Brigham and Women's Hospital — Boston, Massachusetts, United States
• Newton-Wellesley Hospital — Newton, Massachusetts, United States
• Henry Ford Hospital — Detroit, Michigan, United States
• The University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States
• Duke University Medical Center — Durham, North Carolina, United States
• Children's Hospital of Pittsburgh — Pittsburgh, Pennsylvania, United States
• Rhode Island/Lifespan — Providence, Rhode Island, United States
• The University of Texas- Houston — Houston, Texas, United States
• University of Utah Medical Center — Salt Lake City, Utah, United States

Full record on ClinicalTrials.gov

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