A Rapid Test for Acute Respiratory Illness

NCT03192072 | Completed FDA Device

• 2 other identifiers: Pro00082317Pro00082322
• Study Type: observational
• Target: 783
• Locations: 1 country
• Sites: 10

Brief Summary

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. 1.Evaluate the effect of age on the performance of the HR-ARI test
2. 2.Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
3. 3.Evaluate the effect of geography on the performance of the HR-ARI test

Conditions

Respiratory Tract Infection Acute; Transcriptome; Virus Disease; Bacterial Infections

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (1)

• Overall agreement with the reference standard (OA)

  Day 1

Study Arms (1)

Subjects with Acute Respiratory Illness

Patients with acute respiratory illness identified in the Emergency Department

Diagnostic Test: Host Gene Expression

Interventions

Host Gene Expression DIAGNOSTIC_TEST

comparison to retrospective clinical adjudication

Also known as: Adjudication

Subjects with Acute Respiratory Illness

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Up to 750 subjects may be enrolled at a minimum of 3 study sites from geographically diverse locations across the US. Subjects will be approached based on symptoms upon presentation to the health care facility's ED. In addition to these subjects, data from 450 previously enrolled subjects will be used. All demographic groups will have access to enrollment because anyone with acute respiratory infection (ARI) will be approached. Foreign language speaking subjects may be enrolled following review and approval of the appropriate consent process and documents by the reviewing IRB.

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.

Sponsors & Collaborators

• Duke University: lead
• Antibacterial Resistance Leadership Group: collaborator

Study Sites (10)

The University of California- Davis

Davis, California, 95616, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02115, United States

Location

Newton-Wellesley Hospital

Newton, Massachusetts, 02462, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

The University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27514, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

Children's Hospital of Pittsburgh

Pittsburgh, Pennsylvania, 15224, United States

Location

Rhode Island/Lifespan

Providence, Rhode Island, 02903, United States

Location

The University of Texas- Houston

Houston, Texas, 77030, United States

Location

University of Utah Medical Center

Salt Lake City, Utah, 84132, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Samples will include blood, urine, nasopharyngeal and throat swabs

MeSH Terms

Conditions

Virus Diseases; Bacterial Infections

Condition Hierarchy (Ancestors)

Infections; Bacterial Infections and Mycoses

Study Officials

• Christopher Woods, MD, MPH

  Duke University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2017
• First Posted: June 19, 2017
• Study Start: July 17, 2017
• Primary Completion: September 6, 2019
• Study Completion: December 19, 2019
• Last Updated: May 27, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)