An interventional study of FilmArray RP EZ in Respiratory Tract Infections, sponsored by BioFire Diagnostics, LLC. Completed at 1 site in United States. Open to participants aged Up to 100 Years. Per ClinicalTrials.gov, last updated 2017-09-25.
Sponsored by BioFire Diagnostics, LLC · Not applicable, Interventional, and Diagnostic
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.
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 subject's provider's 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, and/or parental permission will be obtained from all study participants.
751 studies on the registry are indexed under Respiratory Tract Infections; 114 are open to participants now.
This study's enrollment of 83 is below the median of 200 across 540 interventional studies indexed under Respiratory Tract Infections.
Browse Respiratory Tract Infections studies →BioFire Diagnostics, LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Subjects receive standard of care testing as determined by the clinician.
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
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
Time duration from initial visit to receipt of appropriate therapy
Time to appropriate therapy as measured in days compared between intervention and control arms.
Time frame: through study completion, an average of one year
Satisfaction scores
Subject and clinician satisfaction with healthcare encounter as measured on 4 point preference scale (highly satisfied, satisfied, dissatisfied, highly dissatisfied) and compared between intervention and control arms
Time frame: through study completion, an average of one year
Total healthcare costs
Comparison of total healthcare costs measured in dollars for patients in Control vs Intervention arm
Time frame: through study completion, an average of one year
Plan to share: No
No publications or documents are linked to this record.
Ran from Apr 2017 to primary completion in Sep 2017, 5 months.
Of 27 industry-sponsored interventional studies with no phase under Respiratory Tract Infections, half reached primary completion within 6 months of starting (the median), counting those still running; a quarter within 4 and three quarters within 13. This study's 5 months is below that.
Counting every sponsor, half of 143 studies reached it within 11 months; a quarter within 6 and three quarters within 29.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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Respiratory Tract Infections →
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