An observational study in Respiratory Tract Infection Acute, Transcriptome and Virus Disease, sponsored by Duke University. Completed at 10 sites in United States. Open to participants aged 2 Years and older. Per ClinicalTrials.gov, last updated 2020-05-27.
Sponsored by Duke University · Observational
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:
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:
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 783 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Duke University is the lead sponsor of 2,025 studies on the registry; 275 are open to participants now.
Of its 194 completed or terminated interventional studies of FDA-regulated products, 159 (82%) have results posted.
Counted across the registry records on this site, refreshed daily.
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.
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:
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.
Patients with acute respiratory illness identified in the Emergency Department
Diagnostic Test: Host Gene Expression
comparison to retrospective clinical adjudication
Also known as: Adjudication
Positive predictive value with reference standard (PPV)
Number of assay positives that agree with the reference standard / \[Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard\]
Time frame: Day 1
Negative predictive value with the reference standard (NPV)
Number of assay negatives that agree with the reference standard / \[number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard\]
Time frame: Day 1
Overall agreement with the reference standard (OA)
Number of samples that agree with the reference standard / all samples tested
Time frame: Day 1
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in May 2020. You cannot join it, but the record below documents what was studied.
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