<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/NCT02968355</url>
  </required_header>
  <id_info>
    <org_study_id>SDY-017266</org_study_id>
    <secondary_id>HHSN272201600002C</secondary_id>
    <secondary_id>W911QY-13-D-0080</secondary_id>
    <nct_id>NCT02968355</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of the FilmArray® Global Fever (GF) Panel</brief_title>
  <official_title>Clinical Evaluation of the FilmArray® Global Fever (GF) Panel</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFire Defense LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>United States Department of Defense</agency>
      <agency_class>U.S. Fed</agency_class>
    </collaborator>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>BioFire Defense LLC</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the clinical sensitivity and specificity of the FilmArray Global&#xD;
      Fever (GF) Panel.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the&#xD;
      U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate&#xD;
      whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel&#xD;
      are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus,&#xD;
      Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis,&#xD;
      Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A,&#xD;
      Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P.&#xD;
      ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the&#xD;
      sensitivity and specificity of the GF Panel when used to test blood collected from subjects&#xD;
      with fever or who have recently had fever. This multi-center study is being conducted at&#xD;
      locations around the world.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">March 26, 2018</start_date>
  <completion_date type="Anticipated">June 2022</completion_date>
  <primary_completion_date type="Actual">March 30, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel</measure>
    <time_frame>18 months</time_frame>
    <description>Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay</description>
  </primary_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Actual">2084</enrollment>
  <condition>Fever</condition>
  <arm_group>
    <arm_group_label>Subjects/Specimens</arm_group_label>
    <description>Subjects/Specimens that meet the eligibility criteria</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Observational study</intervention_name>
    <description>Observational study</description>
    <arm_group_label>Subjects/Specimens</arm_group_label>
    <other_name>FilmArray</other_name>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Whole blood specimen may be retained at the participating clinical sites for future use.&#xD;
      Specimen nucleic acid may be retained at BioFire and participating clinical sites for future&#xD;
      performance evaluations of the FilmArray.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects with fever will be prospectively enrolled, and whole blood will be collected.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Whole blood in EDTA (prospectively collected via informed consent)&#xD;
&#xD;
          -  Subject has a recorded or self-reported fever within the past two days.&#xD;
&#xD;
          -  Subject has not participated in the study within the last 30 days.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Cynthia Phillips, Ph. D.</last_name>
    <role>Study Director</role>
    <affiliation>BioFire Defense LLC</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>George Washington University</name>
      <address>
        <city>Washington</city>
        <state>District of Columbia</state>
        <zip>20037</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Washington University</name>
      <address>
        <city>Saint Louis</city>
        <state>Missouri</state>
        <zip>63110</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Medical Research Unit Two</name>
      <address>
        <city>Phnom Penh</city>
        <country>Cambodia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United States Army Medical Research Directorate Georgia</name>
      <address>
        <city>Tbilisi</city>
        <country>Georgia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Medical Research Unit Three</name>
      <address>
        <city>Navrongo</city>
        <country>Ghana</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Universidad Nacional Autonoma de Honduras</name>
      <address>
        <city>Tegucigalpa</city>
        <state>Central District</state>
        <country>Honduras</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>United States Army Medical Research Directorate Kenya</name>
      <address>
        <city>Kisumu</city>
        <country>Kenya</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Naval Medical Research Unit Six</name>
      <address>
        <city>Iquitos</city>
        <country>Peru</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Kilimanjaro Christian Medical Centre</name>
      <address>
        <city>Moshi</city>
        <country>Tanzania</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Armed Forces Research Institute of Medical Sciences</name>
      <address>
        <city>Bangkok</city>
        <country>Thailand</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Infectious Diseases Institute</name>
      <address>
        <city>Kampala</city>
        <country>Uganda</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Cambodia</country>
    <country>Georgia</country>
    <country>Ghana</country>
    <country>Honduras</country>
    <country>Kenya</country>
    <country>Peru</country>
    <country>Tanzania</country>
    <country>Thailand</country>
    <country>Uganda</country>
    <country>United States</country>
  </location_countries>
  <removed_countries>
    <country>India</country>
  </removed_countries>
  <verification_date>November 2021</verification_date>
  <study_first_submitted>November 16, 2016</study_first_submitted>
  <study_first_submitted_qc>November 16, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 18, 2016</study_first_posted>
  <last_update_submitted>November 16, 2021</last_update_submitted>
  <last_update_submitted_qc>November 16, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">November 17, 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>Fever</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD will not be shared with other researchers.</ipd_description>
  </patient_data>
  <provided_document_section>
    <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 22, 2020</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/55/NCT02968355/ICF_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT02968355
org study id: SDY-017266
secondary id: HHSN272201600002C
secondary id: W911QY-13-D-0080
nct id: NCT02968355
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
This study will evaluate the clinical sensitivity and specificity of the FilmArray Global
      Fever (GF) Panel.
The FilmArray Global Fever (GF) Panel, developed by BioFire Defense in collaboration with the
      U.S. Department of Defense and NIAID, uses an automated, multiplex PCR system to evaluate
      whole blood samples for 19 pathogens simultaneously in under an hour. Targets of the GF Panel
      are Chikungunya virus, CCHF virus, dengue virus (serotypes 1-4), Ebolavirus, Lassa virus,
      Marburgvirus, West Nile virus, Yellow fever virus, Zika virus, Bacillus anthracis,
      Francisella tularensis, Leptospira spp., Salmonella enterica serovar Typhi and Paratyphi A,
      Yersinia pestis, Leishmania donovani complex, Plasmodium spp., P. falciparum, and P.
      ovale/vivax. BioFire Defense is conducting a prospective clinical study to evaluate the
      sensitivity and specificity of the GF Panel when used to test blood collected from subjects
      with fever or who have recently had fever. This multi-center study is being conducted at
      locations around the world.
observational model: Case-Only
time perspective: Prospective
measure: Clinical sensitivity and specificity of the FilmArray Global Fever (GF) Panel
time frame: 18 months
description: Percent Positive Agreement and Percent Negative Agreement between FilmArray Result and Comparator Assay
arm group label: Subjects/Specimens
description: Subjects/Specimens that meet the eligibility criteria
intervention type: Other
intervention name: Observational study
description: Observational study
arm group label: Subjects/Specimens
other name: FilmArray
Whole blood specimen may be retained at the participating clinical sites for future use.
      Specimen nucleic acid may be retained at BioFire and participating clinical sites for future
      performance evaluations of the FilmArray.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Cynthia Phillips, Ph. D.
role: Study Director
affiliation: BioFire Defense LLC
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
facility: 
country: Cambodia
country: Georgia
country: Ghana
country: Honduras
country: Kenya
country: Peru
country: Tanzania
country: Thailand
country: Uganda
country: United States
country: India
responsible party type: Sponsor
mesh term: Fever
sharing ipd: No
ipd description: IPD will not be shared with other researchers.
provided document: 