Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel
NCT ID: NCT03361670
Last Updated: 2017-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
1689 participants
OBSERVATIONAL
2016-10-31
2017-07-31
Brief Summary
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Detailed Description
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Clinical performance evaluations will be initiated at a minimum of three sites to determine the clinical performance of the FilmArray LRTI Panel for each of the analytes on the panel when testing bronchoalveolar lavage (BAL, including mini-BAL) and sputum (including endotracheal aspirates) specimens from subjects with suspected lower respiratory tract (LRT) infections. The intention is for these performance data to support regulatory classifications of the FilmArray LRTI Panel as an in vitro diagnostic device in the US, European Union (EU), Canada, and other regions. The study sites selected will have expertise in the diagnosis of LRTIs, and will be able to conduct the evaluation in accordance with this protocol and Good Clinical Practices (GCP). Prior to performing the prospective clinical evaluation, each participating site will have the necessary Institutional Review Board (IRB) or Ethics Committee (EC) reviews.
Specimens for inclusion in this study will be residual, de-identified BAL or sputum specimens leftover from clinician-ordered lower respiratory pathogen testing.
Comparator testing will be performed using de-identified specimen aliquots at a central reference laboratory and at BioFire.
This study is funded by BioFire Diagnostics, LLC.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Specimens that meet inclusion criteria
Observational Study
Interventions
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Observational Study
Eligibility Criteria
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Inclusion Criteria
* Specimen has not been centrifuged
* Specimen has not been pre-treated
* Specimen has at least 1.5 mL of residual volume
* Specimen was collected from a subject not already enrolled in the study
* Specimen is fresh (stored at \~4°C, not frozen) and was enrolled with 24 hours of collection
Exclusion Criteria
* Specimen was collected from a subject known to have cystic fibrosis
* Specimen was collected from a subject known to have tuberculosis
* Specimen was collected from a subject that was previously enrolled in the study
* Specimen has been stored for longer than 24 hours, or was frozen, or stored at room temperature for longer than 4 hours.
ALL
No
Sponsors
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BioFire Diagnostics, LLC
INDUSTRY
Responsible Party
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Locations
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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
Indiana University School of Medicine
Indianapolis, Indiana, United States
University of Nebraska Medical Center
Omaha, Nebraska, United States
Nationwide Children's Hospital
Columbus, Ohio, United States
The Ohio State University College of Medicine
Columbus, Ohio, United States
Wisconsin Medical Center
Milwaukee, Wisconsin, United States
Countries
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Other Identifiers
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DX-SDY-024947
Identifier Type: -
Identifier Source: org_study_id
NCT02929680
Identifier Type: -
Identifier Source: nct_alias