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Completed

NCT Number: NCT02880384

Pathogen Detection and Community Acquired Pneumonia

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.

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Key information

Conditions

Community Acquired Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Pneumonia Respiratory Tract Diseases Respiratory Tract Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Portland Providence Medical Center

Portland, Oregon, 97213, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Emergency Department physician diagnosis of CAP requiring hospitalization

Exclusion criteria

  • Inability to obtain sputum or sputum equivalent

Treatment and study plan

FilmArray LRTI v.2.0 IUO Panel

Other

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

Primary outcomes

  1. Pathogen Detection

    Time frame: 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 outcomes

  1. Treatment Influence

    Time frame: 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.

  2. Nasopharyngeal swabs compared to sputum

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Providence Health & Services

Other

Collaborators

  • BioFire Diagnostics, LLC

Registry information

Official study title

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

Important dates

Study start
2017
Primary completion
2018
Study completion
2020
First posted
Aug 26, 2016
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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