Pathogen Detection and Community Acquired Pneumonia

Providence Health & Services

Status: Completed

Conditions: Community Acquired Pneumonia

Treatments: Other: FilmArray LRTI v.2.0 IUO Panel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT02880384

16-172A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 570 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion criteria

• Inability to obtain sputum or sputum equivalent

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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570 participants in 1 patient group

FilmArray LRTI v.2.0 IUO Panel

Experimental group

Description:

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

Treatment:

Other: FilmArray LRTI v.2.0 IUO Panel