<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/NCT02979730</url>
  </required_header>
  <id_info>
    <org_study_id>H-35841</org_study_id>
    <nct_id>NCT02979730</nct_id>
  </id_info>
  <brief_title>Impact of Rapid Flu Testing in BMC ED</brief_title>
  <acronym>FluProcess</acronym>
  <official_title>Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Boston Medical Center</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Boston Medical Center</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to compare Emergency Department patients who undergo influenza&#xD;
      testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located&#xD;
      in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who&#xD;
      agree to participate will have their samples randomly assigned to be tested on either at the&#xD;
      core lab, or on the POC device. The current turnaround time for samples sent to the&#xD;
      laboratory is approximately two hours; investigators expect that the point of care device can&#xD;
      reduce this time. Investigators will determine if the time to disposition and the&#xD;
      administration of antibiotics is different in the group undergoing POC influenza testing&#xD;
      compared to those undergoing laboratory-based influenza testing&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 7, 2017</start_date>
  <completion_date type="Actual">December 1, 2017</completion_date>
  <primary_completion_date type="Actual">December 1, 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>Parallel Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Time to Disposition</measure>
    <time_frame>By the End of the ED visit (an average time of 4 hours)</time_frame>
    <description>The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Delivery of prescription or administration of antibiotics</measure>
    <time_frame>by the end of ED visit (an average time of 4 hours)</time_frame>
    <description>Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">233</enrollment>
  <condition>Influenza-Like Illness</condition>
  <condition>Influenza</condition>
  <arm_group>
    <arm_group_label>Core Lab Testing Arm</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>For patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays. The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.). Which test is ordered is at the discretion of the physician. Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ED Point of Care Testing Arm</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Prior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC. The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm. The Cobas Liat assay provides a result callout to distinguish influenza type A from type B.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Core Lab Test</intervention_name>
    <description>For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.</description>
    <arm_group_label>Core Lab Testing Arm</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>ED Point of Care Test</intervention_name>
    <description>For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay</description>
    <arm_group_label>ED Point of Care Testing Arm</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Adult patients 21 years of age or older&#xD;
&#xD;
          -  Presenting to the BMC main ED or Urgent Care area with influenza-like illness&#xD;
&#xD;
          -  Physician ordered an influenza A/B diagnostic test&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previously enrolled in the study&#xD;
&#xD;
          -  Any Influenza test result already available at the time approached by the ED RA&#xD;
&#xD;
          -  Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an&#xD;
             initial influenza A/B-only test.&#xD;
&#xD;
          -  Unable to give informed consent&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>21 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Elissa Perkins, MD, MPH</last_name>
    <role>Principal Investigator</role>
    <affiliation>Boston University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Boston University Medical Center</name>
      <address>
        <city>Boston</city>
        <state>Massachusetts</state>
        <zip>02118</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>November 22, 2016</study_first_submitted>
  <study_first_submitted_qc>November 29, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 2, 2016</study_first_posted>
  <last_update_submitted>July 23, 2018</last_update_submitted>
  <last_update_submitted_qc>July 23, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">July 24, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Boston Medical Center</investigator_affiliation>
    <investigator_full_name>Elissa Schechter-Perkins</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Influenza, Human</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/NCT02979730
org study id: H-35841
nct id: NCT02979730
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The purpose of the study is to compare Emergency Department patients who undergo influenza
      testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located
      in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who
      agree to participate will have their samples randomly assigned to be tested on either at the
      core lab, or on the POC device. The current turnaround time for samples sent to the
      laboratory is approximately two hours; investigators expect that the point of care device can
      reduce this time. Investigators will determine if the time to disposition and the
      administration of antibiotics is different in the group undergoing POC influenza testing
      compared to those undergoing laboratory-based influenza testing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Diagnostic
masking: None (Open Label)
measure: Time to Disposition
time frame: By the End of the ED visit (an average time of 4 hours)
description: The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record
measure: Delivery of prescription or administration of antibiotics
time frame: by the end of ED visit (an average time of 4 hours)
description: Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD
arm group label: Core Lab Testing Arm
arm group type: Active Comparator
description: For patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays. The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.). Which test is ordered is at the discretion of the physician. Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B.
arm group label: ED Point of Care Testing Arm
arm group type: Experimental
description: Prior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC. The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm. The Cobas Liat assay provides a result callout to distinguish influenza type A from type B.
intervention type: Other
intervention name: Core Lab Test
description: For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.
arm group label: Core Lab Testing Arm
intervention type: Other
intervention name: ED Point of Care Test
description: For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay
arm group label: ED Point of Care Testing Arm
criteria: 
gender: All
minimum age: 21 Years
maximum age: N/A
healthy volunteers: No
last name: Elissa Perkins, MD, MPH
role: Principal Investigator
affiliation: Boston University
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: Boston Medical Center
investigator full name: Elissa Schechter-Perkins
investigator title: Principal Investigator
mesh term: Influenza, Human
sharing ipd: No