Pathogen Detection and Community Acquired Pneumonia
Primary Purpose
Community Acquired Pneumonia
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
FilmArray LRTI v.2.0 IUO Panel
Sponsored by
About this trial
This is an interventional diagnostic trial for Community Acquired Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Emergency Department physician diagnosis of CAP requiring hospitalization
Exclusion Criteria:
- Inability to obtain sputum or sputum equivalent
Sites / Locations
- Portland Providence Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
FilmArray LRTI v.2.0 IUO Panel
Arm Description
Patients will provide sputum or sputum equivalent for FilmArray LRTI v.2.0 IUO Panel testing.
Outcomes
Primary Outcome Measures
Pathogen Detection
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 Outcome Measures
Treatment Influence
Determine the number of cases in which the FilmArray LRTI v.2.0 IUO Panel could allow for a switch from empiric to specific antimicrobial therapy if the results had been known by the healthcare provider.
Nasopharyngeal swabs compared to sputum
Compare the number of pathogens detected using an approved PCR panel using nasopharyngeal swabs to the number detected using the FilmArray LRTI v.2.0 IUO Panel.
Full Information
NCT ID
NCT02880384
First Posted
August 23, 2016
Last Updated
May 24, 2022
Sponsor
Providence Health & Services
Collaborators
BioFire Diagnostics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT02880384
Brief Title
Pathogen Detection and Community Acquired Pneumonia
Official Title
Projected Influence of Enhanced Pathogen Detection on the Clinical Management of Community-Acquired Pneumonia
Study Type
Interventional
2. Study Status
Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
January 2017 (Actual)
Primary Completion Date
April 1, 2018 (Actual)
Study Completion Date
December 20, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Providence Health & Services
Collaborators
BioFire Diagnostics, LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Community Acquired Pneumonia
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
570 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FilmArray LRTI v.2.0 IUO Panel
Arm Type
Experimental
Arm Description
Patients will provide sputum or sputum equivalent for FilmArray LRTI v.2.0 IUO Panel testing.
Intervention Type
Other
Intervention Name(s)
FilmArray LRTI v.2.0 IUO Panel
Intervention Description
Patients will provide sputum or sputum equivalent to be probed with FilmArray LRTI v.2.0 IUO Panelpanel.
Primary Outcome Measure Information:
Title
Pathogen Detection
Description
Compare the number of CAP pathogens detected using current diagnostic bundle to the number detected using the FilmArray LRTI v.2.0 IUO Panel.
Time Frame
5 Days
Secondary Outcome Measure Information:
Title
Treatment Influence
Description
Determine the number of cases in which the FilmArray LRTI v.2.0 IUO Panel could allow for a switch from empiric to specific antimicrobial therapy if the results had been known by the healthcare provider.
Time Frame
5 Days
Title
Nasopharyngeal swabs compared to sputum
Description
Compare the number of pathogens detected using an approved PCR panel using nasopharyngeal swabs to the number detected using the FilmArray LRTI v.2.0 IUO Panel.
Time Frame
5 Days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Emergency Department physician diagnosis of CAP requiring hospitalization
Exclusion Criteria:
Inability to obtain sputum or sputum equivalent
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Gilbert, MD
Organizational Affiliation
Providence Health & Services
Official's Role
Principal Investigator
Facility Information:
Facility Name
Portland Providence Medical Center
City
Portland
State/Province
Oregon
ZIP/Postal Code
97213
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pathogen Detection and Community Acquired Pneumonia
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