Pathogen Detection and Community Acquired Pneumonia

Not Applicable

Completed

• Conditions: Community Acquired Pneumonia
• Interventions: Other: FilmArray LRTI v.2.0 IUO Panel

• Registration Number: NCT02880384
• Lead Sponsor: 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.

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.

Study Timeline

• Study First Submitted: 2016-08-23
• Study First Submitted QC: 2016-08-25
• Study First Posted: 2016-08-26
• Study Start: 2017-01
• Primary Completion: 2018-04-01
• Study Completion: 2020-12-20
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-24
• Last Update Posted: 2022-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 570

Inclusion Criteria

• Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion Criteria

• Inability to obtain sputum or sputum equivalent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
Pathogen Detection	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

Name	Time	Method
Treatment Influence	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.
Nasopharyngeal swabs compared to sputum	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.

Trial Locations

Locations (1)

Portland Providence Medical Center; 🇺🇸 Portland, Oregon, United States