NCT03192072

A Rapid Test for Acute Respiratory Illness

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 783 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 2 Years
• Healthy volunteers: Not accepted

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.

Conditions

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Host Gene Expression	comparison to retrospective clinical adjudication

Timeline

• Start date: 2017-07-17
• Primary completion: 2019-09-06
• Completion: 2019-12-19
• First posted: 2017-06-19
• Last updated: 2020-05-27

Locations

10 sites across 1 country: United States

Regulatory

• FDA-regulated device study