Ignite Creation Date:
2024-05-06 @ 9:36 AM
Last Modification Date:
2024-10-26 @ 12:17 PM
Study NCT ID:
NCT03029299
Status:
COMPLETED
Last Update Posted:
2017-09-25
First Post:
2017-01-14
Brief Title:
Implementation Assessment and Clinical Utility of the FilmArray Respiratory Panel RP EZ in a CLIA-waived Setting
Sponsor:
BioFire Diagnostics LLC
Organization:
BioFire Diagnostics LLC
Study Overview
Official Title:
Implementation Assessment and Clinical Utility of the FilmArray Respiratory Panel RP EZ in a CLIA-waived Setting
Status:
COMPLETED
Status Verified Date:
2017-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 20 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
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
Detailed Description:
The FilmArray RP EZ may offer improvements over conventional CLIA-waived testing for respiratory infections Molecular-based testing provides increased sensitivity and specificity relative to current clinical reference methods and multiplexed panels offer a greater breadth of organism identification and diagnostic yield than is available using standard methods available in the CLIA-waived setting Because of these attributes the results from this test have the potential to enable clinicians to more accurately diagnose and treat respiratory illness
It is hypothesized that the sensitive specific and comprehensive results provided by FilmArray RP EZ will allow clinicians to more rapidly diagnose respiratory illness and implement appropriate therapy as well as provide subjects with appropriate expectations about their course of illness
This interventional clinical trial that will be initiated during the 2016-2017 respiratory illness season to measure the utility of FilmArray RP EZ when implemented in an outpatient care setting At least three different outpatient or urgent care clinics within the UCLA Health system will be selected for participation Subjects will be randomized into two groups within each site The control group will receive standard of care according to the subjects providers determination The intervention group will receive testing with FilmArray RP EZ
Outcome measures will include but are not limited to total healthcare costs antimicrobial prescription rates timeliness and appropriateness of therapy clinician attitudes towards laboratory test capabilities and subject satisfaction with their healthcare encounter
As specimens will be collected specifically for this research study written informed consent assent andor parental permission will be obtained from all study participants
It is hypothesized that the sensitive specific and comprehensive results provided by FilmArray RP EZ will allow clinicians to more rapidly diagnose respiratory illness and implement appropriate therapy as well as provide subjects with appropriate expectations about their course of illness
This interventional clinical trial that will be initiated during the 2016-2017 respiratory illness season to measure the utility of FilmArray RP EZ when implemented in an outpatient care setting At least three different outpatient or urgent care clinics within the UCLA Health system will be selected for participation Subjects will be randomized into two groups within each site The control group will receive standard of care according to the subjects providers determination The intervention group will receive testing with FilmArray RP EZ
Outcome measures will include but are not limited to total healthcare costs antimicrobial prescription rates timeliness and appropriateness of therapy clinician attitudes towards laboratory test capabilities and subject satisfaction with their healthcare encounter
As specimens will be collected specifically for this research study written informed consent assent andor parental permission will be obtained from all study participants
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None