<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/NCT03299283</url>
  </required_header>
  <id_info>
    <org_study_id>804 Pilot</org_study_id>
    <nct_id>NCT03299283</nct_id>
  </id_info>
  <brief_title>Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing</brief_title>
  <official_title>Specimen Collection and Transport Workflow Evaluations for CLIA-waived Molecular Testing</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>BioFire Diagnostics, LLC</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>BioFire Diagnostics, LLC</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_unapproved_device>Yes</is_unapproved_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is two-fold. In the first phase, the goal is to characterize the&#xD;
      stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and&#xD;
      stool (raw stool and rectal swab) specimens collected using various standard, medically&#xD;
      established procedures with and without transport media and tested at various time points and&#xD;
      under different temperature conditions, and also to look at variation between repeat sampling&#xD;
      events. The intention is for these data to support decisions made by BioFire regarding the&#xD;
      appropriate specimen type and handling guidelines for future tests. In the second phase of&#xD;
      the study, collection and transport conditions identified in Phase 1 will be used to collect&#xD;
      specimens for pilot performance evaluations of a new molecular diagnostic test.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This evaluation will be initiated at several sites in the US. In the first phase of the&#xD;
      study, multiple specimens will be collected from each subject and tested using various&#xD;
      pre-analytical techniques. Current BioFire FilmArray test panels will be used to assay each&#xD;
      specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or&#xD;
      other post-collection variables. In the second phase of the study only two specimens will be&#xD;
      collected from each subject: one for testing with the new test (using handling procedures&#xD;
      identified in Phase 1) and another for testing with the reference method. Up to 2,000&#xD;
      subjects will be enrolled across all sites in each phase (up to 4,000 subjects total).&#xD;
      Enrollment is expected to last approximately 18 months to cover both phases of the study. All&#xD;
      specimens and subject data will be de-identified and coded. Prior to study initiation, each&#xD;
      participating site will have the necessary Institutional Review Board (IRB) reviews.&#xD;
      Specimens in both phases will be tested at the study site using various BioFire test&#xD;
      platforms and cartridges.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Enrolling by invitation</last_known_status>
  <start_date type="Actual">October 5, 2017</start_date>
  <completion_date type="Anticipated">December 30, 2019</completion_date>
  <primary_completion_date type="Anticipated">October 30, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Analyte stability (as measured by nucleic acid detection)</measure>
    <time_frame>Through completion of Phase 1 (approximartely 9 months)</time_frame>
    <description>Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will investigate analyte stability for the various pre-analytical steps. Analyte stability will be measured by assessing nucleic acid level using real-time PCR.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Device performance relative to reference methods</measure>
    <time_frame>Through completion of Phase 2 (approximately 9 months)</time_frame>
    <description>Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will determine device performance relative to reference method(s) i.e. if an anlyte is detected (or not) by each method (presence or absence)</description>
  </secondary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">4000</enrollment>
  <condition>Respiratory Tract Infections</condition>
  <condition>Gastrointestinal Infection</condition>
  <arm_group>
    <arm_group_label>Respiratory/Pharyngitis</arm_group_label>
    <description>Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gastrointestinal</arm_group_label>
    <description>Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>BioFire test platform</intervention_name>
    <description>Analysis of analyte stability under various conditions as measured by BioFire test platforms</description>
    <arm_group_label>Gastrointestinal</arm_group_label>
    <arm_group_label>Respiratory/Pharyngitis</arm_group_label>
  </intervention>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Respiratory and gastrointestinal specimens collected using medically established techniques&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects present to ED or urgent care centers with signs/symptoms of respiratory tract or&#xD;
        gastrointestinal infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Subject presents with signs/symptoms of respiratory infection including but not&#xD;
             limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache,&#xD;
             chills, or fatigue. OR Subject presents with suspected gastroenteritis (e.g. diarrhea,&#xD;
             vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days&#xD;
&#xD;
          -  If age 18 or over, subject provides written informed consent&#xD;
&#xD;
          -  If under the age of 18, parental permission and assent (as appropriate) is obtained&#xD;
&#xD;
          -  Subject is willing and able to provide at least two (up to three) specimens: any&#xD;
             combination of NS, NPS, or TS OR rectal swab or stool&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Subject is unable to provide consent or parental permission and assent (as&#xD;
             appropriate) cannot be obtained&#xD;
&#xD;
          -  Subject is unable or unwilling to provide two specimens&#xD;
&#xD;
          -  Subject's health care provider determines that specimen collection represents an&#xD;
             unacceptable risk&#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>Kevin Bourzac, PhD</last_name>
    <role>Study Director</role>
    <affiliation>BioFire Diagnostics</affiliation>
  </overall_official>
  <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_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>July 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 27, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>January 14, 2019</last_update_submitted>
  <last_update_submitted_qc>January 14, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 15, 2019</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <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/NCT03299283
org study id: 804 Pilot
nct id: NCT03299283
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: Yes
is unapproved device: Yes
is us export: No
The purpose of this study is two-fold. In the first phase, the goal is to characterize the
      stability of respiratory (nasal swab, nasopharyngeal swab, and throat swab; NS, NPS, TS) and
      stool (raw stool and rectal swab) specimens collected using various standard, medically
      established procedures with and without transport media and tested at various time points and
      under different temperature conditions, and also to look at variation between repeat sampling
      events. The intention is for these data to support decisions made by BioFire regarding the
      appropriate specimen type and handling guidelines for future tests. In the second phase of
      the study, collection and transport conditions identified in Phase 1 will be used to collect
      specimens for pilot performance evaluations of a new molecular diagnostic test.
This evaluation will be initiated at several sites in the US. In the first phase of the
      study, multiple specimens will be collected from each subject and tested using various
      pre-analytical techniques. Current BioFire FilmArray test panels will be used to assay each
      specimen and evaluate the multiple variables: repeat sampling, native specimen stability, or
      other post-collection variables. In the second phase of the study only two specimens will be
      collected from each subject: one for testing with the new test (using handling procedures
      identified in Phase 1) and another for testing with the reference method. Up to 2,000
      subjects will be enrolled across all sites in each phase (up to 4,000 subjects total).
      Enrollment is expected to last approximately 18 months to cover both phases of the study. All
      specimens and subject data will be de-identified and coded. Prior to study initiation, each
      participating site will have the necessary Institutional Review Board (IRB) reviews.
      Specimens in both phases will be tested at the study site using various BioFire test
      platforms and cartridges.
observational model: Cohort
time perspective: Prospective
measure: Analyte stability (as measured by nucleic acid detection)
time frame: Through completion of Phase 1 (approximartely 9 months)
description: Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will investigate analyte stability for the various pre-analytical steps. Analyte stability will be measured by assessing nucleic acid level using real-time PCR.
measure: Device performance relative to reference methods
time frame: Through completion of Phase 2 (approximately 9 months)
description: Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising the FilmArray Panel with respect to reference methods will determine device performance relative to reference method(s) i.e. if an anlyte is detected (or not) by each method (presence or absence)
arm group label: Respiratory/Pharyngitis
description: Subject presents with signs/symptoms of respiratory infection including but not limited to fever, cough, sore throat (pharyngitis), runny nose, myalgia, headache, chills, or fatigue
arm group label: Gastrointestinal
description: Subject presents with suspected gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) with duration of symptoms less than or equal to 7 days
intervention type: Diagnostic Test
intervention name: BioFire test platform
description: Analysis of analyte stability under various conditions as measured by BioFire test platforms
arm group label: Gastrointestinal
arm group label: Respiratory/Pharyngitis
Respiratory and gastrointestinal specimens collected using medically established techniques
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Kevin Bourzac, PhD
role: Study Director
affiliation: BioFire Diagnostics
facility: 
country: United States
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Respiratory Tract Infections
sharing ipd: No