Pathogen Detection and Community Acquired Pneumonia

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02880384

Enrollment

570

Registered

2016-08-26

Start date

2017-01-31

Completion date

2020-12-20

Last updated

2022-05-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Community Acquired Pneumonia

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.

Interventions

OTHERFilmArray LRTI v.2.0 IUO Panel

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

ALL

Healthy volunteers

Inclusion criteria

* Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion criteria

* Inability to obtain sputum or sputum equivalent

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026