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NCT02880384 Clinical Trial

Pathogen Detection and Community Acquired Pneumonia

Community Acquired Pneumonia Clinical Trial

Official title:
Projected Influence of Enhanced Pathogen Detection on the Clinical Management of Community-Acquired Pneumonia

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02880384
Other study ID # 16-172A
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 2017
Est. completion date December 20, 2020

Study information
Verified date May 2022
Source Providence Health & Services
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 570
Est. completion date December 20, 2020
Est. primary completion date April 1, 2018
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion Criteria: - Emergency Department physician diagnosis of CAP requiring hospitalization Exclusion Criteria: - Inability to obtain sputum or sputum equivalent

Study Design

Related Conditions & MeSH terms

Intervention

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.

Locations
Country Name City State
United States Portland Providence Medical Center Portland Oregon

Sponsors (2)
Lead Sponsor Collaborator
Providence Health & Services BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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. 5 Days
Secondary 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. 5 Days
Secondary 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. 5 Days
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