Ignite Creation Date:
2024-05-06 @ 9:02 AM
Last Modification Date:
2024-10-26 @ 12:08 PM
Study NCT ID:
NCT02880384
Status:
COMPLETED
Last Update Posted:
2022-05-25
First Post:
2016-08-23
Brief Title:
Pathogen Detection and Community Acquired Pneumonia
Sponsor:
Providence Health Services
Organization:
Providence Health Services
Study Overview
Official Title:
Projected Influence of Enhanced Pathogen Detection on the Clinical Management of Community-Acquired Pneumonia
Status:
COMPLETED
Status Verified Date:
2022-05
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:
None
Brief Summary:
Study to compare the number of community-acquired pneumonia CAP pathogens detected using current diagnostic tests to the number detected using the BioFire Diagnostics investigational polymerase chain reaction PCR platform
Detailed Description:
Patients diagnosed in the emergency department with CAP that requires hospitalization provide a sputum sample for culture and sensitivity testing urine for detection of S pneumonia and L pneumophila an anterior nasal swab for S aureus PCR a nasopharyngeal swab for S pneumonia PCR and the FilmArray LRTI v20 IUO Panel and blood for procalcitonin testing and in cases in which the patient is suffering rigors and hypotension cultures As part of this study sputum or sputum equivalent will be acquired for testing using the FilmArray LRTI v20 IUO Panel
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None