Pathogen Detection and Community Acquired Pneumonia

NCT ID: NCT02880384

Last Updated: 2022-05-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

570 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-31

Study Completion Date

2020-12-20

Brief Summary

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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

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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.

Conditions

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Community Acquired Pneumonia

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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FilmArray LRTI v.2.0 IUO Panel

Patients will provide sputum or sputum equivalent for FilmArray LRTI v.2.0 IUO Panel testing.

Group Type EXPERIMENTAL

FilmArray LRTI v.2.0 IUO Panel

Intervention Type OTHER

Patients will provide sputum or sputum equivalent to be probed with FilmArray LRTI v.2.0 IUO Panelpanel.

Interventions

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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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion Criteria

* Inability to obtain sputum or sputum equivalent
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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BioFire Diagnostics, LLC

INDUSTRY

Sponsor Role collaborator

Providence Health & Services

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Gilbert, MD

Role: PRINCIPAL_INVESTIGATOR

Providence Health & Services

Locations

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Portland Providence Medical Center

Portland, Oregon, United States

Site Status

Countries

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United States

Other Identifiers

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16-172A

Identifier Type: -

Identifier Source: org_study_id

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