<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/NCT02248285</url>
  </required_header>
  <id_info>
    <org_study_id>DX-SDY-019839</org_study_id>
    <secondary_id>R01AI104593</secondary_id>
    <nct_id>NCT02248285</nct_id>
  </id_info>
  <brief_title>Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study</brief_title>
  <acronym>IMPACT</acronym>
  <official_title>Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFire Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>BioFire Diagnostics, LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a&#xD;
      rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common&#xD;
      microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/)&#xD;
      from a stool specimen collected in Cary Blair enteric transport media. The test was made&#xD;
      available for sale in the US and EU following FDA clearance and CE marking in May, 2014.&#xD;
&#xD;
      The FilmArray GI Panel offers improvements over conventional laboratory testing which&#xD;
      include: reduced turnaround time from specimen to result, reduced laboratory labor costs,&#xD;
      increased sensitivity and specificity relative to current clinical reference methods, and&#xD;
      larger breadth of organism identification than is available using standard methods. Because&#xD;
      of these attributes, the results from this test have the potential to enable clinicians to&#xD;
      more accurately diagnose and treat GI illness in a reduced time frame.&#xD;
&#xD;
      Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics&#xD;
      have designed a study to evaluate health outcomes of pediatric subjects presenting to&#xD;
      emergency departments with GI illness before and after establishing the FilmArray GI Panel as&#xD;
      the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (~&#xD;
      1 hour turnaround time), sensitive, specific, and comprehensive results provided by the&#xD;
      FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate&#xD;
      appropriate therapy and provide guidance when compared to the pre-implementation period.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">August 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel</measure>
    <time_frame>Seven to ten days after enrollment</time_frame>
    <description>Describing of etiology of diarrheal illness in the study as identified by each method</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">1545</enrollment>
  <condition>Infectious Gastroenteritis</condition>
  <arm_group>
    <arm_group_label>Intervention</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Pre-intervention</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>FilmArray™ Gastrointestinal (GI) Panel</intervention_name>
    <description>BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014</description>
    <arm_group_label>Intervention</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children (&lt;18 years) presenting to the ED or onsite urgent care center with symptoms&#xD;
             of gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.)&#xD;
&#xD;
          -  Duration of symptoms at least 24 hours but &lt; 14 days&#xD;
&#xD;
          -  Able to provide stool specimen at time of enrollment or within the next two calendar&#xD;
             days&#xD;
&#xD;
          -  Parent or guardian able to provide permission and subject able to provide assent, if&#xD;
             appropriate&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Undefined onset of illness or symptoms for ≥14 days&#xD;
&#xD;
          -  Unable to complete questionnaire or give informed consent because of language barrier&#xD;
&#xD;
          -  Those unable to provide stool specimen at time of enrollment or within two calendar&#xD;
             days&#xD;
&#xD;
          -  Previous enrollment in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital of Los Angeles</name>
      <address>
        <city>Los Angeles</city>
        <state>California</state>
        <zip>90027</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Children's Mercy Hospital</name>
      <address>
        <city>Kansas City</city>
        <state>Missouri</state>
        <zip>64108</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Nationwide Children's Hospital</name>
      <address>
        <city>Columbus</city>
        <state>Ohio</state>
        <zip>43205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Brown University, Lifespan</name>
      <address>
        <city>Providence</city>
        <state>Rhode Island</state>
        <zip>02903</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>University of Utah, Primary Children's Hospital</name>
      <address>
        <city>Salt Lake City</city>
        <state>Utah</state>
        <zip>84132</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <reference>
    <citation>Poritz MA, Blaschke AJ, Byington CL, Meyers L, Nilsson K, Jones DE, Thatcher SA, Robbins T, Lingenfelter B, Amiott E, Herbener A, Daly J, Dobrowolski SF, Teng DH, Ririe KM. FilmArray, an automated nested multiplex PCR system for multi-pathogen detection: development and application to respiratory tract infection. PLoS One. 2011;6(10):e26047. doi: 10.1371/journal.pone.0026047. Epub 2011 Oct 19. Erratum In: PLoS One. 2011;6(11). doi: 10.1371/annotation/468cfdcd-184c-42f7-a1d0-3b72a2f6a558.</citation>
    <PMID>22039434</PMID>
  </reference>
  <reference>
    <citation>FDA. FDA clearance for FilmArray Gastrointestinal Panel, May 2, 2014. http://www.accessdata.fda.gov/cdrh_docs/reviews/K140407.pdf (2014).</citation>
  </reference>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>September 18, 2014</study_first_submitted>
  <study_first_submitted_qc>September 22, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 25, 2014</study_first_posted>
  <results_first_submitted>October 16, 2017</results_first_submitted>
  <results_first_submitted_qc>November 29, 2017</results_first_submitted_qc>
  <results_first_posted type="Actual">December 26, 2017</results_first_posted>
  <last_update_submitted>November 29, 2017</last_update_submitted>
  <last_update_submitted_qc>November 29, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">December 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>multiplex</keyword>
  <keyword>polymerase chain reaction</keyword>
  <keyword>PCR</keyword>
  <keyword>BioFire Diagnostics</keyword>
  <keyword>Infectious gastroenteritis</keyword>
  <keyword>Diarrheal disease</keyword>
  <keyword>Emergency department</keyword>
  <keyword>rapid diagnostics</keyword>
  <keyword>FilmArray</keyword>
  <keyword>FilmArray GI Panel</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Gastroenteritis</mesh_term>
  </condition_browse>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Intervention</title>
          <description>FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.&#xD;
FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014</description>
        </group>
        <group group_id="P2">
          <title>Pre-intervention</title>
          <description>Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="687"/>
                <participants group_id="P2" count="858"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="586"/>
                <participants group_id="P2" count="571"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="101"/>
                <participants group_id="P2" count="287"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Intervention</title>
          <description>FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.&#xD;
FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014</description>
        </group>
        <group group_id="B2">
          <title>Pre-intervention</title>
          <description>Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.</description>
        </group>
        <group group_id="B3">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="586"/>
            <count group_id="B2" value="571"/>
            <count group_id="B3" value="1157"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="586"/>
                    <count group_id="B2" value="571"/>
                    <count group_id="B3" value="1157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="586"/>
                    <measurement group_id="B2" value="571"/>
                    <measurement group_id="B3" value="1157"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="586"/>
                    <count group_id="B2" value="571"/>
                    <count group_id="B3" value="1157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="2.7" lower_limit="1.2" upper_limit="7.8"/>
                    <measurement group_id="B2" value="3" lower_limit="1.2" upper_limit="7.0"/>
                    <measurement group_id="B3" value="2.8" lower_limit="1.2" upper_limit="7.8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="586"/>
                    <count group_id="B2" value="571"/>
                    <count group_id="B3" value="1157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="272"/>
                    <measurement group_id="B2" value="300"/>
                    <measurement group_id="B3" value="572"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="314"/>
                    <measurement group_id="B2" value="271"/>
                    <measurement group_id="B3" value="585"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race and Ethnicity Not Collected</title>
          <population>Race and Ethnicity were not collected from any participant.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="0"/>
                    <count group_id="B2" value="0"/>
                    <count group_id="B3" value="0"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <analyzed_list>
                <analyzed>
                  <units>Participants</units>
                  <scope>Class</scope>
                  <count_list>
                    <count group_id="B1" value="586"/>
                    <count group_id="B2" value="571"/>
                    <count group_id="B3" value="1157"/>
                  </count_list>
                </analyzed>
              </analyzed_list>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="586"/>
                    <measurement group_id="B2" value="571"/>
                    <measurement group_id="B3" value="1157"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel</title>
        <description>Describing of etiology of diarrheal illness in the study as identified by each method</description>
        <time_frame>Seven to ten days after enrollment</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Intervention</title>
            <description>FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.&#xD;
FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014</description>
          </group>
          <group group_id="O2">
            <title>Pre-intervention</title>
            <description>Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.</description>
          </group>
        </group_list>
        <measure>
          <title>Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel</title>
          <description>Describing of etiology of diarrheal illness in the study as identified by each method</description>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="586"/>
                <count group_id="O2" value="64"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="434"/>
                    <measurement group_id="O2" value="19"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <group_list>
        <group group_id="E1">
          <title>Intervention</title>
          <description>FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.&#xD;
FilmArray™ Gastrointestinal (GI) Panel: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014</description>
        </group>
        <group group_id="E2">
          <title>Pre-intervention</title>
          <description>Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.</description>
        </group>
      </group_list>
      <serious_events>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, all-cause mortality</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="586"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="571"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="586"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="571"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>0</frequency_threshold>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="586"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="571"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed. </restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Director of Clinical Affairs</name_or_title>
      <organization>BioFire Diagnostics</organization>
      <phone>8017366354</phone>
      <email>kevin.bourzac@biofiredx.com</email>
    </point_of_contact>
  </clinical_results>
</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/NCT02248285
org study id: DX-SDY-019839
secondary id: R01AI104593
nct id: NCT02248285
lead sponsor: 
collaborator: 
has dmc: No
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a
      rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common
      microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/)
      from a stool specimen collected in Cary Blair enteric transport media. The test was made
      available for sale in the US and EU following FDA clearance and CE marking in May, 2014.

      The FilmArray GI Panel offers improvements over conventional laboratory testing which
      include: reduced turnaround time from specimen to result, reduced laboratory labor costs,
      increased sensitivity and specificity relative to current clinical reference methods, and
      larger breadth of organism identification than is available using standard methods. Because
      of these attributes, the results from this test have the potential to enable clinicians to
      more accurately diagnose and treat GI illness in a reduced time frame.

      Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics
      have designed a study to evaluate health outcomes of pediatric subjects presenting to
      emergency departments with GI illness before and after establishing the FilmArray GI Panel as
      the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (~
      1 hour turnaround time), sensitive, specific, and comprehensive results provided by the
      FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate
      appropriate therapy and provide guidance when compared to the pre-implementation period.
allocation: Non-Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel
time frame: Seven to ten days after enrollment
description: Describing of etiology of diarrheal illness in the study as identified by each method
arm group label: Intervention
arm group type: Experimental
description: FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.
arm group label: Pre-intervention
arm group type: No Intervention
description: Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
intervention type: Device
intervention name: FilmArray™ Gastrointestinal (GI) Panel
description: BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014
arm group label: Intervention
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
citation: Poritz MA, Blaschke AJ, Byington CL, Meyers L, Nilsson K, Jones DE, Thatcher SA, Robbins T, Lingenfelter B, Amiott E, Herbener A, Daly J, Dobrowolski SF, Teng DH, Ririe KM. FilmArray, an automated nested multiplex PCR system for multi-pathogen detection: development and application to respiratory tract infection. PLoS One. 2011;6(10):e26047. doi: 10.1371/journal.pone.0026047. Epub 2011 Oct 19. Erratum In: PLoS One. 2011;6(11). doi: 10.1371/annotation/468cfdcd-184c-42f7-a1d0-3b72a2f6a558.
PMID: 22039434
citation: FDA. FDA clearance for FilmArray Gastrointestinal Panel, May 2, 2014. http://www.accessdata.fda.gov/cdrh_docs/reviews/K140407.pdf (2014).
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Gastroenteritis
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 