<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03029299</url>
  </required_header>
  <id_info>
    <org_study_id>DX-SDY-031041</org_study_id>
    <nct_id>NCT03029299</nct_id>
  </id_info>
  <brief_title>Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting</brief_title>
  <official_title>Implementation Assessment and Clinical Utility of the FilmArray® Respiratory Panel (RP) EZ in a CLIA-waived Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFire Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of California, Los Angeles</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>BioFire Diagnostics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      BioFire Diagnostics, LLC (BioFire; a bioMerieux company), has developed a multiplexed&#xD;
      molecular-based in vitro diagnostic platform for infectious disease testing known as the&#xD;
      FilmArray. The FilmArray Respiratory Panel (RP) EZ is a test designed for use with the&#xD;
      FilmArray 2.0 EZ Configuration instrument that identifies common bacterial and viral&#xD;
      microorganisms associated with respiratory tract infections from a nasopharyngeal swab (NPS)&#xD;
      specimen collected in viral transport media (VTM). The RP EZ was granted CLIA-waived&#xD;
      classification by the FDA in October 2016 and is the first highly-multiplexed molecular test&#xD;
      to receive this designation.&#xD;
&#xD;
      The purpose of this study is to measure patient outcomes following implementation of the RP&#xD;
      EZ test and to also gather data about physician office workflow and user interactions with&#xD;
      the device. These data will be used to understand how the adoption of such tests may&#xD;
      influence patient care in the CLIA-waived setting.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FilmArray RP EZ may offer improvements over conventional CLIA-waived testing for&#xD;
      respiratory infections. Molecular-based testing provides increased sensitivity and&#xD;
      specificity relative to current clinical reference methods and multiplexed panels offer a&#xD;
      greater breadth of organism identification and diagnostic yield than is available using&#xD;
      standard methods available in the CLIA-waived setting. Because of these attributes, the&#xD;
      results from this test have the potential to enable clinicians to more accurately diagnose&#xD;
      and treat respiratory illness.&#xD;
&#xD;
      It is hypothesized that the sensitive, specific, and comprehensive results provided by&#xD;
      FilmArray RP EZ will allow clinicians to more rapidly diagnose respiratory illness and&#xD;
      implement appropriate therapy, as well as provide subjects with appropriate expectations&#xD;
      about their course of illness.&#xD;
&#xD;
      This interventional clinical trial that will be initiated during the 2016-2017 respiratory&#xD;
      illness season to measure the utility of FilmArray RP EZ when implemented in an outpatient&#xD;
      care setting. At least three different outpatient or urgent care clinics within the UCLA&#xD;
      Health system will be selected for participation. Subjects will be randomized into two groups&#xD;
      within each site. The control group will receive standard of care according to the subject's&#xD;
      provider's determination. The intervention group will receive testing with FilmArray RP EZ.&#xD;
&#xD;
      Outcome measures will include (but are not limited to) total healthcare costs, antimicrobial&#xD;
      prescription rates, timeliness, and appropriateness of therapy, clinician attitudes towards&#xD;
      laboratory test capabilities, and subject satisfaction with their healthcare encounter.&#xD;
&#xD;
      As specimens will be collected specifically for this research study, written informed&#xD;
      consent, assent, and/or parental permission will be obtained from all study participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 4, 2017</start_date>
  <completion_date type="Actual">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">September 15, 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time duration from initial visit to receipt of appropriate therapy</measure>
    <time_frame>through study completion, an average of one year</time_frame>
    <description>Time to appropriate therapy as measured in days compared between intervention and control arms.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Satisfaction scores</measure>
    <time_frame>through study completion, an average of one year</time_frame>
    <description>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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Total healthcare costs</measure>
    <time_frame>through study completion, an average of one year</time_frame>
    <description>Comparison of total healthcare costs measured in dollars for patients in Control vs Intervention arm</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">83</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Subjects receive standard of care testing as determined by the clinician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>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)</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FilmArray RP EZ</intervention_name>
    <description>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</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject presents with signs/symptoms of respiratory infection including but not&#xD;
             limited to fever, cough, sore throat, runny nose, myalgia, headache, chills, or&#xD;
             fatigue.&#xD;
&#xD;
          -  Subject provides written informed consent/assent/parental permission&#xD;
&#xD;
          -  Willing and able to provide NPS specimen&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is unable to provide consent/assent/parental permission&#xD;
&#xD;
          -  Children whose legal guardian is not available to give permission&#xD;
&#xD;
          -  Unable/unwilling to provide NPS specimen&#xD;
&#xD;
          -  Non-English speaking&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of California, Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90095</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>January 14, 2017</study_first_submitted>
  <study_first_submitted_qc>January 20, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 24, 2017</study_first_posted>
  <last_update_submitted>September 22, 2017</last_update_submitted>
  <last_update_submitted_qc>September 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 25, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03029299
org study id: DX-SDY-031041
nct id: NCT03029299
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Time duration from initial visit to receipt of appropriate therapy
time frame: through study completion, an average of one year
description: Time to appropriate therapy as measured in days compared between intervention and control arms.
measure: Satisfaction scores
time frame: through study completion, an average of one year
description: 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
measure: Total healthcare costs
time frame: through study completion, an average of one year
description: Comparison of total healthcare costs measured in dollars for patients in Control vs Intervention arm
arm group label: Control
arm group type: No Intervention
description: Subjects receive standard of care testing as determined by the clinician.
arm group label: Intervention
arm group type: Experimental
description: 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)
intervention type: Device
intervention name: FilmArray RP EZ
description: 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
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: 100 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
sharing ipd: No