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Pathogen Detection and Community Acquired Pneumonia

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ClinicalTrials.gov Identifier: NCT02880384
Recruitment Status : Unknown
Verified June 2018 by Providence Health & Services.
Recruitment status was:  Active, not recruiting
First Posted : August 26, 2016
Last Update Posted : June 7, 2018
Sponsor:
Collaborator:
BioFire Diagnostics, LLC
Information provided by (Responsible Party):
Providence Health & Services

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.

Condition or disease Intervention/treatment Phase
Community Acquired Pneumonia Other: FilmArray LRTI v.2.0 IUO Panel Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 570 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Projected Influence of Enhanced Pathogen Detection on the Clinical Management of Community-Acquired Pneumonia
Actual Study Start Date : January 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

Arm Intervention/treatment
Experimental: FilmArray LRTI v.2.0 IUO Panel
Patients will provide sputum or sputum equivalent for FilmArray LRTI v.2.0 IUO Panel testing.
Other: FilmArray LRTI v.2.0 IUO Panel
Patients will provide sputum or sputum equivalent to be probed with FilmArray LRTI v.2.0 IUO Panelpanel.




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Treatment Influence [ Time Frame: 5 Days ]
    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.

  2. Nasopharyngeal swabs compared to sputum [ Time Frame: 5 Days ]
    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.



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion Criteria:

  • Inability to obtain sputum or sputum equivalent

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02880384


Locations
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United States, Oregon
Portland Providence Medical Center
Portland, Oregon, United States, 97213
Sponsors and Collaborators
Providence Health & Services
BioFire Diagnostics, LLC
Investigators
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Principal Investigator: David Gilbert, MD Providence Health & Services
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Responsible Party: Providence Health & Services
ClinicalTrials.gov Identifier: NCT02880384    
Other Study ID Numbers: 16-172A
First Posted: August 26, 2016    Key Record Dates
Last Update Posted: June 7, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections