<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/NCT02232711</url>
  </required_header>
  <id_info>
    <org_study_id>SDY-014162</org_study_id>
    <secondary_id>HDTRA1-09-C0068</secondary_id>
    <nct_id>NCT02232711</nct_id>
  </id_info>
  <brief_title>Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting</brief_title>
  <official_title>Evaluation of Accuracy and Ease of Use of the FilmArray™ Respiratory Panel (RP EZ) in a CLIA-Waived Clinical Setting</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFire Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
  </sponsors>
  <source>BioFire Diagnostics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray&#xD;
      Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's&#xD;
      instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments&#xD;
      (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with&#xD;
      signs and/or symptoms of a respiratory infection. The study data will be used to support an&#xD;
      application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized&#xD;
      that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with&#xD;
      be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or&#xD;
      high complexity CLIA certification.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>November 2014</start_date>
  <completion_date type="Actual">July 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness</measure>
    <time_frame>1.5 hour</time_frame>
    <description>In general, performance of the FilmArray RP EZ test in the CLIA-waived setting is expected to meet at least 95% positive and negative percent agreement with the results obtained from FilmArray RP in the moderate/high- complexity setting for each pathogen on the panel.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Epidemiology of respiratory infections in a CLIA-waived setting</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>Seasonality and rate of respiratory infection at each of the CLIA-waived sites using the FilmArray RP EZ to collect prospectively enrolled specimens will be evaluated at the end of the study.</description>
  </secondary_outcome>
  <enrollment type="Actual">1082</enrollment>
  <condition>Upper Respiratory Infections</condition>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Nasopharyngeal swab (NPS) specimens&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Individuals with signs and/or symptoms of respiratory infections&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Displays signs and/or symptoms of respiratory infections&#xD;
&#xD;
          -  Adult patients must provide informed consent&#xD;
&#xD;
          -  Parental consent for children (&lt;18)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Adult patients unable to provide informed consent&#xD;
&#xD;
          -  Children that are currently in foster care, or are wards of the state&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Naval Health Research Center</name>
      <address>
        <city>San Diego</city>
        <state>California</state>
        <zip>92152</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Barnes-Jewish/Washington University School of Medicine</name>
      <address>
        <city>St. Louis</city>
        <state>Missouri</state>
        <zip>63103</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UTMB Primary Care Pavilion</name>
      <address>
        <city>Galveston</city>
        <state>Texas</state>
        <zip>77550</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>South Main Clinic</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84115</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Barenfanger J, Drake C, Leon N, Mueller T, Troutt T. Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000 Aug;38(8):2824-8. doi: 10.1128/JCM.38.8.2824-2828.2000.</citation>
    <PMID>10921934</PMID>
  </reference>
  <reference>
    <citation>Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007.</citation>
    <PMID>23931834</PMID>
  </reference>
  <reference>
    <citation>Fairfax MR, Salimnia H. Diagnostic molecular microbiology: a 2013 snapshot. Clin Lab Med. 2013 Dec;33(4):787-803. doi: 10.1016/j.cll.2013.08.003.</citation>
    <PMID>24267186</PMID>
  </reference>
  <verification_date>July 2015</verification_date>
  <study_first_submitted>August 28, 2014</study_first_submitted>
  <study_first_submitted_qc>September 3, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 5, 2014</study_first_posted>
  <last_update_submitted>July 23, 2015</last_update_submitted>
  <last_update_submitted_qc>July 23, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">July 24, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multiplex, polymerase chain reaction, PCR, BioFire, respiratory infection, infectious disease, point of care, CLIA waived, rapid diagnostics</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Respiratory Tract Infections</mesh_term>
  </condition_browse>
  <!-- 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/NCT02232711
org study id: SDY-014162
secondary id: HDTRA1-09-C0068
nct id: NCT02232711
lead sponsor: 
collaborator: 
has dmc: No
The purpose of this study is to assess the accuracy and ease-of-use of a simplified FilmArray
      Respiratory Panel test (FilmArray RP EZ) when performed according to the manufacturer's
      instructions by personnel in laboratories holding Clinical Laboratory Improvement Amendments
      (CLIA) waivers (or equivalent) on nasopharyngeal swab samples obtained from volunteers with
      signs and/or symptoms of a respiratory infection. The study data will be used to support an
      application to the FDA for CLIA-waived categorization of FilmArray RP EZ. It is hypothesized
      that the results of the FilmArray RP EZ test performed in a laboratory with CLIA waiver with
      be 95% accurate when compared to FilmArray RP testing performed in a lab with a moderate or
      high complexity CLIA certification.
observational model: Case-Only
time perspective: Prospective
measure: Accuracy of FilmArray RP EZ System in detecting cause of respiratory illness
time frame: 1.5 hour
description: In general, performance of the FilmArray RP EZ test in the CLIA-waived setting is expected to meet at least 95% positive and negative percent agreement with the results obtained from FilmArray RP in the moderate/high- complexity setting for each pathogen on the panel.
measure: Epidemiology of respiratory infections in a CLIA-waived setting
time frame: Up to 9 months
description: Seasonality and rate of respiratory infection at each of the CLIA-waived sites using the FilmArray RP EZ to collect prospectively enrolled specimens will be evaluated at the end of the study.
Nasopharyngeal swab (NPS) specimens
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Barenfanger J, Drake C, Leon N, Mueller T, Troutt T. Clinical and financial benefits of rapid detection of respiratory viruses: an outcomes study. J Clin Microbiol. 2000 Aug;38(8):2824-8. doi: 10.1128/JCM.38.8.2824-2828.2000.
PMID: 10921934
citation: Buller RS. Molecular detection of respiratory viruses. Clin Lab Med. 2013 Sep;33(3):439-60. doi: 10.1016/j.cll.2013.03.007.
PMID: 23931834
citation: Fairfax MR, Salimnia H. Diagnostic molecular microbiology: a 2013 snapshot. Clin Lab Med. 2013 Dec;33(4):787-803. doi: 10.1016/j.cll.2013.08.003.
PMID: 24267186
responsible party type: Sponsor
mesh term: Respiratory Tract Infections