Prospective Clinical Evaluation of the FilmArray® Lower Respiratory Tract Infection (LRTI) Panel (LRTI)

Prospective Clinical Evaluation of the FilmArray Lower Respiratory Tract Infection (LRTI) Panel

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.

Study Overview

• Status: Completed
• Conditions: Lower Resp Tract Infection
• Intervention / Treatment: Other: Observational Study

Detailed Description

BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray. The FilmArray Lower Respiratory Tract Infection (LRTI) Panel is a test designed for use with the FilmArray that identifies common bacterial, viral, and fungal microorganisms as well as antimicrobial resistance gene targets associated with lower respiratory tract infections. The FilmArray LRTI Panel also provides quantitation for some bacterial analytes.

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.

• Study Type: Observational
• Enrollment (Actual): 1689

Contacts and Locations

Study Locations

• United States
  • California
    • Los Angeles, California, United States, 90095
      • University of California, Los Angeles
    • Los Angeles, California, United States, 90027
      • Children's Hospital of Los Angeles
  • Illinois
    • Maywood, Illinois, United States, 60153
      • Loyola University Medical Center
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Nebraska
    • Omaha, Nebraska, United States, 68198
      • University of Nebraska Medical Center
  • Ohio
    • Columbus, Ohio, United States, 43210
      • The Ohio State University College of Medicine
    • Columbus, Ohio, United States, 43205
      • Nationwide Children's Hospital
  • Wisconsin
    • Milwaukee, Wisconsin, United States, 53226
      • Wisconsin Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: ADULT; OLDER_ADULT; CHILD
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Only residual BAL or sputum specimens from patients with clinician-ordered lower respiratory pathogen testing will be enrolled.

Description

Inclusion Criteria:

• Specimen is residual LRT specimen (sputum, ETA, BAL, or mini-BAL) that was submitted under clinician order for standard care LRT testing
• 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 centrifuged, pre-treated, or is less than 1.5mL
• 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Specimens that meet inclusion criteria	Other: Observational Study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
sensitivity and specificity of device	10 months

Collaborators and Investigators

• Sponsor: BioFire Diagnostics, LLC

Study record dates

Study Major Dates

• Study Start (ACTUAL): October 1, 2016
• Primary Completion (ACTUAL): July 1, 2017
• Study Completion (ACTUAL): July 1, 2017

Study Registration Dates

• First Submitted: November 29, 2017
• First Submitted That Met QC Criteria: November 29, 2017
• First Posted (ACTUAL): December 5, 2017

Study Record Updates

• Last Update Posted (ACTUAL): December 5, 2017
• Last Update Submitted That Met QC Criteria: November 29, 2017
• Last Verified: November 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Infections; Communicable Diseases; Respiratory Tract Infections
• Other Study ID Numbers: DX-SDY-024947

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO