Ignite Creation Date:
2024-05-06 @ 10:14 AM
Last Modification Date:
2024-10-26 @ 12:26 PM
Study NCT ID:
NCT03192072
Status:
COMPLETED
Last Update Posted:
2020-05-27
First Post:
2017-06-16
Brief Title:
A Rapid Test for Acute Respiratory Illness
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
Status:
COMPLETED
Status Verified Date:
2020-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Radical
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 NBNV 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 raceethnicity on the performance of the HR-ARI test
3 Evaluate the effect of geography on the performance of the HR-ARI test
Secondary objectives include
1 Evaluate the effect of age on the performance of the HR-ARI test
2 Evaluate the effect of raceethnicity 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 NBNV 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 raceethnicity 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 patients 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 subjects 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
Secondary objectives include
1 Evaluate the effect of age on the performance of the HR-ARI test
2 Evaluate the effect of raceethnicity 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 patients 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 subjects 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
True
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Pro00082322 | OTHER | Duke UMC | None |