<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/NCT03756753</url>
  </required_header>
  <id_info>
    <org_study_id>18-1492</org_study_id>
    <nct_id>NCT03756753</nct_id>
  </id_info>
  <brief_title>The RAPID Trial: Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics</brief_title>
  <acronym>RAPID</acronym>
  <official_title>The RAPID Trial: Randomized Controlled Trial Assessing Point-of-care Influenza and Other Respiratory Virus Diagnostics</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Colorado, Denver</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Biofire</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Colorado, Denver</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid&#xD;
      respiratory test in a pediatric emergency department. Participants will be randomized to the&#xD;
      intervention group - results available to medical providers, or the control group- results&#xD;
      not available to medical providers.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in&#xD;
      children presenting to an Emergency Department setting with acute respiratory symptoms. The&#xD;
      patient cohort will be children 1 month to 18 years of age presenting to the Children's&#xD;
      Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as&#xD;
      level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population&#xD;
      who are evaluated in an urgent care setting. All eligible participants will undergo a&#xD;
      nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by&#xD;
      computer-generated randomization to either the intervention group - test result available to&#xD;
      providers, or the control group- test result not available (routine clinical care). The&#xD;
      investigators will compare the clinical outcomes between the two groups.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 3, 2019</start_date>
  <completion_date type="Actual">December 31, 2020</completion_date>
  <primary_completion_date type="Actual">December 31, 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>
    <intervention_model_description>Participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care).</intervention_model_description>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
    <masking_description>Patients will be enrolled in the study, and will not initially know their study arm. After enrollment, the professional research assistant (PRA) will find out the study arm. Providers will be notified of the results for the intervention group. Providers are able to let patients know of their results.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit</measure>
    <time_frame>day 0</time_frame>
    <description>Proportion of children who are prescribed an antibiotic at the ED visit.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of children treated with influenza antiviral at the ED visit</measure>
    <time_frame>day 0</time_frame>
    <description>Proportion of patients treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit</measure>
    <time_frame>day 0</time_frame>
    <description>Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>ED length of stay (hours)</measure>
    <time_frame>day 0</time_frame>
    <description>Length of stay (in hours) in emergency department at the visit in which a subject is enrolled in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Days of Hospitalization</measure>
    <time_frame>day 0-10</time_frame>
    <description>Proportion of patients hospitalized within 10 days of enrollment in the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of repeat ED visits</measure>
    <time_frame>day 0-10</time_frame>
    <description>Number of repeat ED visits within 10 days of enrollment in the study</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of tests ordered</measure>
    <time_frame>day 0</time_frame>
    <description>Number of tests ordered (labs, imaging, microbiologic testing) during visit in which a subject is enrolled in the study.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Relative clinical charges</measure>
    <time_frame>day 0</time_frame>
    <description>Relative clinical charges for ED visit in which a subject is enrolled in the study.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">913</enrollment>
  <condition>Respiratory Pathogens</condition>
  <condition>Upper Respiratory Tract Illness</condition>
  <condition>Lower Respiratory Tract Illness</condition>
  <condition>Acute Respiratory Infection</condition>
  <arm_group>
    <arm_group_label>Intervention group- results known</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group- results not known</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Results available to provider</intervention_name>
    <description>Results of point of care testing are given to provider</description>
    <arm_group_label>Intervention group- results known</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 1 month to &lt; 18 years&#xD;
&#xD;
          2. For children aged 1 month to 12 months of age: Presentation to the study sites with&#xD;
             temperature &gt; 37.8°C or cough, sore throat, runny nose or nasal congestion&#xD;
&#xD;
          3. For children aged &gt; 1 year to 18 years of age: Presentation to the study sites with&#xD;
             influenza like illness, defined as temperature of &gt;37.8⁰C and at least one of the&#xD;
             following: cough, sore throat, runny nose or nasal congestion&#xD;
&#xD;
          4. Triage Level 3,4,5 based on Emergency Severity Index (refer to Appendix B for&#xD;
             algorithm)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Respiratory symptom duration &gt; 14 days&#xD;
&#xD;
          2. Previous enrollment in study within past 14 days&#xD;
&#xD;
          3. Nurse-only visit&#xD;
&#xD;
          4. Triage levels 1 and 2 based on Emergency Severity Index&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Children's Hospital Colorado</name>
      <address>
        <city>Aurora</city>
        <state>Colorado</state>
        <zip>80045</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 27, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 28, 2018</study_first_posted>
  <last_update_submitted>November 5, 2021</last_update_submitted>
  <last_update_submitted_qc>November 5, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2021</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/NCT03756753
org study id: 18-1492
nct id: NCT03756753
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The RAPID trial is a randomized controlled trial that looks at the clinical impact of a rapid
      respiratory test in a pediatric emergency department. Participants will be randomized to the
      intervention group - results available to medical providers, or the control group- results
      not available to medical providers.
The RAPID trial is a randomized controlled trial of rapid respiratory viral testing in
      children presenting to an Emergency Department setting with acute respiratory symptoms. The
      patient cohort will be children 1 month to 18 years of age presenting to the Children's
      Hospital Colorado (CHCO) Emergency Department with influenza like illness who are triaged as
      level 3, 4, or 5 by the Emergency Severity Index, representing the typical patient population
      who are evaluated in an urgent care setting. All eligible participants will undergo a
      nasopharyngeal swab and point of care testing, and participants will be allocated 1:1 by
      computer-generated randomization to either the intervention group - test result available to
      providers, or the control group- test result not available (routine clinical care). The
      investigators will compare the clinical outcomes between the two groups.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Participants will be allocated 1:1 by computer-generated randomization to either the intervention group - test result available to providers, or the control group- test result not available (routine clinical care).
primary purpose: Other
masking: None (Open Label)
masking description: Patients will be enrolled in the study, and will not initially know their study arm. After enrollment, the professional research assistant (PRA) will find out the study arm. Providers will be notified of the results for the intervention group. Providers are able to let patients know of their results.
measure: Proportion of children prescribed an antibiotic at the Emergency Department (ED) visit
time frame: day 0
description: Proportion of children who are prescribed an antibiotic at the ED visit.
measure: Proportion of children treated with influenza antiviral at the ED visit
time frame: day 0
description: Proportion of patients treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.
measure: Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit
time frame: day 0
description: Proportion of patients who test positive for influenza treated with influenza antiviral at the ED visit in which a subject is enrolled in the study.
measure: ED length of stay (hours)
time frame: day 0
description: Length of stay (in hours) in emergency department at the visit in which a subject is enrolled in the study.
measure: Days of Hospitalization
time frame: day 0-10
description: Proportion of patients hospitalized within 10 days of enrollment in the study
measure: Number of repeat ED visits
time frame: day 0-10
description: Number of repeat ED visits within 10 days of enrollment in the study
measure: Number of tests ordered
time frame: day 0
description: Number of tests ordered (labs, imaging, microbiologic testing) during visit in which a subject is enrolled in the study.
measure: Relative clinical charges
time frame: day 0
description: Relative clinical charges for ED visit in which a subject is enrolled in the study.
arm group label: Intervention group- results known
arm group type: Experimental
description: Providers of patients enrolled in this arm of the study will be notified of the point of care respiratory testing results
arm group label: Control group- results not known
arm group type: No Intervention
description: Providers of patients enrolled in the study will not be notified of the point of care respiratory testing results
intervention type: Diagnostic Test
intervention name: Results available to provider
description: Results of point of care testing are given to provider
arm group label: Intervention group- results known
criteria: 
gender: All
minimum age: 1 Month
maximum age: 18 Years
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Respiratory Tract Infections
sharing ipd: No