<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/NCT03809117</url>
  </required_header>
  <id_info>
    <org_study_id>IRB #051839</org_study_id>
    <nct_id>NCT03809117</nct_id>
  </id_info>
  <brief_title>Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea</brief_title>
  <official_title>A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Andrew Meltzer</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>BioFire Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </collaborator>
  </sponsors>
  <source>George Washington University</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This research study will test a laboratory test called Film-Array Gastrointestinal (GI)&#xD;
      Panel. This GI Panel is a test that can identify the bacteria or viruses that may cause&#xD;
      diarrhea. This test will enable the ED doctor to better understand the cause of diarrhea to&#xD;
      try to determine the best treatment.&#xD;
&#xD;
      The primary objective of this study is to determine if testing ED patients who complain of&#xD;
      diarrhea will lead to more optimal use of antibiotics. Optimal use of antibiotics is defined&#xD;
      as the most appropriate antibiotic to treat a specified pathogen.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study was halted due to obstacles faced in executing clinical procedures as a result of the&#xD;
    COVID-19 pandemic.&#xD;
  </why_stopped>
  <start_date type="Actual">November 19, 2018</start_date>
  <completion_date type="Actual">September 7, 2020</completion_date>
  <primary_completion_date type="Actual">March 15, 2020</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>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Optimal Antibiotic Chosen</measure>
    <time_frame>30 Days post ED Discharge</time_frame>
    <description>Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>ED Length of Stay</measure>
    <time_frame>30 Days post ED Discharge</time_frame>
    <description>Time from patient arrival to time when patient is officially discharged or admitted</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Hospital Admission Rate</measure>
    <time_frame>30 Days post ED Discharge</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Rate of Abdominal/Pelvic CT Scans</measure>
    <time_frame>30 Days post ED Discharge</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">74</enrollment>
  <condition>Infectious Diarrhea</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Biofire Film Array Gastrointestinal Panel</intervention_name>
    <description>The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
    <arm_group_label>Control</arm_group_label>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Presumed infectious diarrhea (3 or more loose stools in past 24 hours)&#xD;
&#xD;
          -  Must have one of the 3 following features or symptoms lasting more than 7 days.&#xD;
&#xD;
               1. Symptoms greater than 24 hours;&#xD;
&#xD;
               2. Dehydration (defined as the need for intravenous fluid or per clinician's&#xD;
                  judgement ((based on the general appearance and alertness of the patient, the&#xD;
                  pulse, the blood pressure, the presence or absence of postural hypotension, the&#xD;
                  mucous membranes and tears, sunken eyes, skin turgor, capillary refill, and&#xD;
                  jugular venous pressure.))&#xD;
&#xD;
               3. Inflammation (defined as fever (greater than 100.1), blood in stool per patient,&#xD;
                  DRE, or tenesmus.)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Chronic Symptoms (&gt;14 days)&#xD;
&#xD;
          -  Inability to Follow- Up (i.e. no telephone)&#xD;
&#xD;
          -  Prisoner&#xD;
&#xD;
          -  Likely non-infectious cause of diarrhea (Crohn's disease, radiation colitis, irritable&#xD;
             bowel syndrome, or celiac disease)&#xD;
&#xD;
          -  Confirmed C. Diff Diarrhea&#xD;
&#xD;
          -  Unable to provide written consent&#xD;
&#xD;
          -  Non- English speaker&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Andrew Meltzer, MD, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>The George Washington University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>The George Washington University, Department of Emergency Medicine</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>November 13, 2018</study_first_submitted>
  <study_first_submitted_qc>January 15, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 18, 2019</study_first_posted>
  <results_first_submitted>October 22, 2021</results_first_submitted>
  <results_first_submitted_qc>November 28, 2022</results_first_submitted_qc>
  <results_first_posted type="Actual">December 20, 2022</results_first_posted>
  <last_update_submitted>November 28, 2022</last_update_submitted>
  <last_update_submitted_qc>November 28, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 20, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>George Washington University</investigator_affiliation>
    <investigator_full_name>Andrew Meltzer</investigator_full_name>
    <investigator_title>Associate Professor of Emergency Medicine</investigator_title>
  </responsible_party>
  <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>Dysentery</mesh_term>
    <mesh_term>Diarrhea</mesh_term>
  </condition_browse>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03809117/Prot_SAP_000.pdf</document_url>
    </provided_document>
    <provided_document>
      <document_type>Informed Consent Form</document_type>
      <document_has_protocol>No</document_has_protocol>
      <document_has_icf>Yes</document_has_icf>
      <document_has_sap>No</document_has_sap>
      <document_date>March 9, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/17/NCT03809117/ICF_001.pdf</document_url>
    </provided_document>
  </provided_document_section>

  <clinical_results>

    <participant_flow>
      <group_list>
        <group group_id="P1">
          <title>Experimental</title>
          <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
        </group>
        <group group_id="P2">
          <title>Control</title>
          <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="38"/>
                <participants group_id="P2" count="36"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
              </participants_list>
            </milestone>
          </milestone_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <group_list>
        <group group_id="B1">
          <title>Experimental</title>
          <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
        </group>
        <group group_id="B2">
          <title>Control</title>
          <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</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="38"/>
            <count group_id="B2" value="36"/>
            <count group_id="B3" value="74"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="34" lower_limit="26" upper_limit="51.25"/>
                    <measurement group_id="B2" value="33" lower_limit="25.75" upper_limit="52.25"/>
                    <measurement group_id="B3" value="34" lower_limit="26" upper_limit="52.75"/>
                  </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>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="23"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="15"/>
                    <measurement group_id="B2" value="17"/>
                    <measurement group_id="B3" value="32"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race/Ethnicity, Customized</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <title>Race</title>
              <category_list>
                <category>
                  <title>Black</title>
                  <measurement_list>
                    <measurement group_id="B1" value="21"/>
                    <measurement group_id="B2" value="21"/>
                    <measurement group_id="B3" value="42"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="10"/>
                    <measurement group_id="B2" value="9"/>
                    <measurement group_id="B3" value="19"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian, Native American, Other, Unknown</title>
                  <measurement_list>
                    <measurement group_id="B1" value="7"/>
                    <measurement group_id="B2" value="6"/>
                    <measurement group_id="B3" value="13"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Optimal Antibiotic Chosen</title>
        <description>Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results.</description>
        <time_frame>30 Days post ED Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Optimal Antibiotic Chosen</title>
          <description>Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results.</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="38"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="13"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>ED Length of Stay</title>
        <description>Time from patient arrival to time when patient is officially discharged or admitted</description>
        <time_frame>30 Days post ED Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
        </group_list>
        <measure>
          <title>ED Length of Stay</title>
          <description>Time from patient arrival to time when patient is officially discharged or admitted</description>
          <units>hours</units>
          <param>Median</param>
          <dispersion>Inter-Quartile Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7.68" lower_limit="6.43" upper_limit="10.67"/>
                    <measurement group_id="O2" value="8.15" lower_limit="5.90" upper_limit="11.23"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Hospital Admission Rate</title>
        <time_frame>30 Days post ED Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Hospital Admission Rate</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="7"/>
                    <measurement group_id="O2" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Rate of Abdominal/Pelvic CT Scans</title>
        <time_frame>30 Days post ED Discharge</time_frame>
        <group_list>
          <group group_id="O1">
            <title>Experimental</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
          <group group_id="O2">
            <title>Control</title>
            <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
          </group>
        </group_list>
        <measure>
          <title>Rate of Abdominal/Pelvic CT Scans</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="38"/>
                <count group_id="O2" value="36"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="8"/>
                    <measurement group_id="O2" value="8"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>Day 7 and Day 30</time_frame>
      <desc>No adverse events were elicited at day 7 or day 30</desc>
      <group_list>
        <group group_id="E1">
          <title>Experimental</title>
          <description>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</description>
        </group>
        <group group_id="E2">
          <title>Control</title>
          <description>Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.&#xD;
Biofire Film Array Gastrointestinal Panel: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.</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="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </event>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </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="38"/>
                <counts group_id="E2" subjects_affected="0" subjects_at_risk="36"/>
              </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>
    <limitations_and_caveats>Early termination leading to small numbers of subjects analyzed</limitations_and_caveats>
    <point_of_contact>
      <name_or_title>Dr. Andrew Meltzer</name_or_title>
      <organization>George Washington University</organization>
      <phone>202-741-2952</phone>
      <email>ameltzer@mfa.gwu.edu</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/NCT03809117
org study id: IRB #051839
nct id: NCT03809117
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
This research study will test a laboratory test called Film-Array Gastrointestinal (GI)
      Panel. This GI Panel is a test that can identify the bacteria or viruses that may cause
      diarrhea. This test will enable the ED doctor to better understand the cause of diarrhea to
      try to determine the best treatment.

      The primary objective of this study is to determine if testing ED patients who complain of
      diarrhea will lead to more optimal use of antibiotics. Optimal use of antibiotics is defined
      as the most appropriate antibiotic to treat a specified pathogen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Number of Participants With Optimal Antibiotic Chosen
time frame: 30 Days post ED Discharge
description: Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results.
measure: ED Length of Stay
time frame: 30 Days post ED Discharge
description: Time from patient arrival to time when patient is officially discharged or admitted
measure: Hospital Admission Rate
time frame: 30 Days post ED Discharge
measure: Rate of Abdominal/Pelvic CT Scans
time frame: 30 Days post ED Discharge
arm group label: Experimental
arm group type: Experimental
description: Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
arm group label: Control
arm group type: Active Comparator
description: Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
intervention type: Diagnostic Test
intervention name: Biofire Film Array Gastrointestinal Panel
description: The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
arm group label: Control
arm group label: Experimental
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Andrew Meltzer, MD, MS
role: Principal Investigator
affiliation: The George Washington University
facility: 
country: United States
responsible party type: Sponsor-Investigator
investigator affiliation: George Washington University
investigator full name: Andrew Meltzer
investigator title: Associate Professor of Emergency Medicine
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Dysentery
mesh term: Diarrhea
provided document: 
provided document: 
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
limitations and caveats: Early termination leading to small numbers of subjects analyzed
point of contact: 