<clinical_study>
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  <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/NCT01734668</url>
  </required_header>
  <id_info>
    <org_study_id>CS-0143-01</org_study_id>
    <nct_id>NCT01734668</nct_id>
  </id_info>
  <brief_title>Sofia RSV FIA Field Study</brief_title>
  <official_title>Sofia RSV FIA Field Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Quidel Corporation</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Quidel Corporation</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA&#xD;
      with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of&#xD;
      age.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>March 2012</start_date>
  <completion_date type="Actual">January 2013</completion_date>
  <primary_completion_date type="Actual">January 2013</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>High level of sensitivity and specificity for performance vs. culture</measure>
    <time_frame>Culture results within 48 hours of plating</time_frame>
    <description>Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.</description>
  </primary_outcome>
  <enrollment type="Actual">2468</enrollment>
  <condition>Respiratory Syncytial Virus</condition>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>In Vitro Diagnostic device to aid in diagnosis</intervention_name>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Recruitment of RSV symptomatic pediatric subjects who are less than nineteen (19) years of&#xD;
        age.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Male or Female&#xD;
&#xD;
          2. Children less than nineteen (19) years of age can participate (assuming appropriate&#xD;
             consent is obtained).&#xD;
&#xD;
          3. Must currently be exhibiting symptoms characteristic of respiratory syncytial virus&#xD;
             (RSV) illness.&#xD;
&#xD;
          4. Subjects must present with one or more of the following to be eligible for enrollment:&#xD;
&#xD;
               -  Fever, ≥ 37.8º C (100º F) at present or within past 24 hours&#xD;
&#xD;
               -  Moderate to severe runny nose*&#xD;
&#xD;
               -  Moderate to severe congestion*&#xD;
&#xD;
               -  Decreased appetite&#xD;
&#xD;
               -  Coughing&#xD;
&#xD;
               -  Sneezing*&#xD;
&#xD;
               -  Wheezing&#xD;
&#xD;
               -  Irritability&#xD;
&#xD;
               -  Decreased activity&#xD;
&#xD;
               -  Labored breathing&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Subjects nineteen years of age or older.&#xD;
&#xD;
          2. The parent or legal guardian is unable to understand and consent to participation.&#xD;
&#xD;
          3. Current or prior treatment during this infection with anti-RSV Synagis®.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>John D Tamerius, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Quidel Corporation</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Best Medical Group</name>
      <address>
        <city>Phoenix</city>
        <state>Arizona</state>
        <zip>85042</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Santo Nino Medical Clinic</name>
      <address>
        <city>Panorama City</city>
        <state>California</state>
        <zip>91402</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Genesis Community Health</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Gentle Medical Associates</name>
      <address>
        <city>Boynton Beach</city>
        <state>Florida</state>
        <zip>33435</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Pediatrics by the Sea</name>
      <address>
        <city>Delray Beach</city>
        <state>Florida</state>
        <zip>33483</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soma Pediatrics</name>
      <address>
        <city>Lake Worth</city>
        <state>Florida</state>
        <zip>33460</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Adriana Castro</name>
      <address>
        <city>Miami</city>
        <state>Florida</state>
        <zip>33173</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Lanza Pediatrics</name>
      <address>
        <city>Pensacola</city>
        <state>Florida</state>
        <zip>32504</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Northeast Pediatrics</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33702</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>St. Petersburg Pediatrics</name>
      <address>
        <city>St. Petersburg</city>
        <state>Florida</state>
        <zip>33710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Teena Hughes, MD</name>
      <address>
        <city>Tampa</city>
        <state>Florida</state>
        <zip>33613</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Soma Medical Center, PA Pediatric Site #3</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33406</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Juan E. Batista, MD PA, Pediatric Site #2</name>
      <address>
        <city>West Palm Beach</city>
        <state>Florida</state>
        <zip>33415</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>FastER Urgent Care</name>
      <address>
        <city>Morris Plains</city>
        <state>New Jersey</state>
        <zip>07950</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Twelve Corners Pediatrics</name>
      <address>
        <city>Rochester</city>
        <state>New York</state>
        <zip>14618</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Veritas, PA</name>
      <address>
        <city>Belton</city>
        <state>Texas</state>
        <zip>76513</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Advanced Pediatrics</name>
      <address>
        <city>Vienna</city>
        <state>Virginia</state>
        <zip>22180</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>February 2013</verification_date>
  <study_first_submitted>November 20, 2012</study_first_submitted>
  <study_first_submitted_qc>November 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 28, 2012</study_first_posted>
  <last_update_submitted>February 5, 2013</last_update_submitted>
  <last_update_submitted_qc>February 5, 2013</last_update_submitted_qc>
  <last_update_posted type="Estimate">February 7, 2013</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT01734668
org study id: CS-0143-01
nct id: NCT01734668
lead sponsor: 
has dmc: No
The objective of this study is to demonstrate the clinical performance of the Sofia RSV FIA
      with specimens from symptomatic pediatric subjects who are less than nineteen (19) years of
      age.
time perspective: Prospective
measure: High level of sensitivity and specificity for performance vs. culture
time frame: Culture results within 48 hours of plating
description: Clinical performance will be based on comparison of the Sofia RSV FIA results to cell culture.
intervention type: Device
intervention name: In Vitro Diagnostic device to aid in diagnosis
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: 18 Years
healthy volunteers: No
last name: John D Tamerius, PhD
role: Study Director
affiliation: Quidel Corporation
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country: United States
responsible party type: Sponsor