A Rapid Test for Acute Respiratory Illness

Completed

• Conditions: Transcriptome; Bacterial Infections; Respiratory Tract Infection Acute; Virus Disease
• Interventions: Diagnostic Test: Host Gene Expression

• Registration Number: NCT03192072
• Lead Sponsor: Duke University

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. 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

Detailed Description

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.

Study Timeline

• Study First Submitted: 2017-06-16
• Study First Submitted QC: 2017-06-16
• Study First Posted: 2017-06-19
• Study Start: 2017-07-17
• Primary Completion: 2019-09-06
• Study Completion: 2019-12-19
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-22
• Last Update Posted: 2020-05-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 783

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Subjects with Acute Respiratory Illness	Host Gene Expression	Patients with acute respiratory illness identified in the Emergency Department

Primary Outcome Measures

Name	Time	Method
Positive predictive value with reference standard (PPV)	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)	Day 1	Number of assay negatives that agree with the reference standard / \[number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard\]

Secondary Outcome Measures

Name	Time	Method
Overall agreement with the reference standard (OA)	Day 1	Number of samples that agree with the reference standard / all samples tested

Trial Locations

Locations (10)

The University of California- Davis; 🇺🇸 Davis, California, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States

University of Utah Medical Center; 🇺🇸 Salt Lake City, Utah, 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