Projected Influence of Enhanced Pathogen Detection on the Clinical Management of Community-Acquired Pneumonia
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Providence Health & Services
- Enrollment
- 570
- Locations
- 1
- Primary Endpoint
- Pathogen Detection
Study Overview
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 v.2.0 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 v.2.0 IUO Panel.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Emergency Department physician diagnosis of CAP requiring hospitalization
Exclusion Criteria
- •Inability to obtain sputum or sputum equivalent
Arms & Interventions
FilmArray LRTI v.2.0 IUO Panel
Patients will provide sputum or sputum equivalent for FilmArray LRTI v.2.0 IUO Panel testing.
Intervention: FilmArray LRTI v.2.0 IUO Panel (Other)
Outcomes
Primary Outcomes
Pathogen Detection
Time Frame: 5 Days
Compare the number of CAP pathogens detected using current diagnostic bundle to the number detected using the FilmArray LRTI v.2.0 IUO Panel.
Secondary Outcomes
- Treatment Influence(5 Days)
- Nasopharyngeal swabs compared to sputum(5 Days)