Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting

NCT03029299 | Completed FDA Device

• 1 other identifier: DX-SDY-031041
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 1

Brief Summary

BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed molecular-based in vitro diagnostic platform for infectious disease testing known as the FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS) specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived classification by the FDA in October 2016 and is the first highly-multiplexed molecular test to receive this designation. The purpose of this study is to measure patient outcomes following implementation of the RP EZ test and to also gather data about physician office workflow and user interactions with the device. These data will be used to understand how the adoption of such tests may influence patient care in the CLIA-waived setting.

Conditions

Respiratory Tract Infections

Outcome Measures

Primary Outcomes (1)

• Time duration from initial visit to receipt of appropriate therapy

  Time to appropriate therapy as measured in days compared between intervention and control arms.

  through study completion, an average of one year

Secondary Outcomes (2)

• Satisfaction scores

  through study completion, an average of one year

• Total healthcare costs

  through study completion, an average of one year

Study Arms (2)

Control

NO INTERVENTION

Subjects receive standard of care testing as determined by the clinician.

Intervention

EXPERIMENTAL

Subjects are tested using the FilmArray RP EZ and the results are provided to the clinician for use in determination of patient care (along with any other clinician-ordered testing)

Device: FilmArray RP EZ

Interventions

FilmArray RP EZ DEVICE

Patients in the intervention arm will be tested with the FilmArray RP EZ and the results of the test will be provided to the treating clinician

Intervention

Eligibility Criteria

• Age: Up to 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, or fatigue.
• Subject provides written informed consent/assent/parental permission
• Willing and able to provide NPS specimen

You may not qualify if:

• Subject is unable to provide consent/assent/parental permission
• Children whose legal guardian is not available to give permission
• Unable/unwilling to provide NPS specimen
• Non-English speaking

Sponsors & Collaborators

• BioFire Diagnostics, LLC: lead
• University of California, Los Angeles: collaborator

Study Sites (1)

University of California, Los Angeles

Los Angeles, California, 90095, United States

Location

MeSH Terms

Conditions

Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Respiratory Tract Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2017
• First Posted: January 24, 2017
• Study Start: April 4, 2017
• Primary Completion: September 15, 2017
• Study Completion: September 15, 2017
• Last Updated: September 25, 2017

Record last verified: 2017-09

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)