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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03361670
Other study ID # DX-SDY-024947
Secondary ID
Status Completed
Phase N/A
First received November 29, 2017
Last updated November 29, 2017
Start date October 2016
Est. completion date July 2017

Study information

Verified date November 2017
Source BioFire Diagnostics, LLC
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This is a performance study to test the sensitivity and specificity of the BioFire FilmArray Lower Respiratory Tract Infection (LRTI) Panel. The purpose of this study is to prospectively collect and test residual Bronchoalveolar lavage (BAL) and sputum specimens and generate performance data to support regulatory classification of the FilmArray LRTI as an in vitro diagnostic (IVD) in the US, European Union (EU), Canada, and other regions.


Description:

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Study Design


Intervention

Other:
Observational Study


Locations

Country Name City State
United States Nationwide Children's Hospital Columbus Ohio
United States The Ohio State University College of Medicine Columbus Ohio
United States Indiana University School of Medicine Indianapolis Indiana
United States Children's Hospital of Los Angeles Los Angeles California
United States University of California, Los Angeles Los Angeles California
United States Loyola University Medical Center Maywood Illinois
United States Wisconsin Medical Center Milwaukee Wisconsin
United States University of Nebraska Medical Center Omaha Nebraska

Sponsors (1)

Lead Sponsor Collaborator
BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary sensitivity and specificity of device 10 months
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