<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/NCT04414189</url>
  </required_header>
  <id_info>
    <org_study_id>INF-06</org_study_id>
    <nct_id>NCT04414189</nct_id>
  </id_info>
  <brief_title>Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial</brief_title>
  <official_title>Clinical Validation of HostDx Sepsis™ on NanoString; a Prospective Observational Validation Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Inflammatix</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University of Florida</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Inflammatix</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>
      This study will analyze HostDx Sepsis results from whole blood samples collected from&#xD;
      patients with suspected sepsis or at risk for sepsis in the surgical ICU&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">June 7, 2020</start_date>
  <completion_date type="Actual">October 19, 2021</completion_date>
  <primary_completion_date type="Actual">July 21, 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>Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.</measure>
    <time_frame>Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year</time_frame>
    <description>Percentage of correctly identified patients with bacterial and/or viral infections using HostDx Sepsis compared to clinical adjudications using routine clinical, laboratory, and other findings</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.</measure>
    <time_frame>Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year</time_frame>
    <description>Percentage of patients with correctly predicted outcomes using HostDx Sepsis (7-day organ support), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.</measure>
    <time_frame>Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year</time_frame>
    <description>Percentage of patients with correctly predicted outcomes using HostDx Sepsis (CCI), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.</measure>
    <time_frame>Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year</time_frame>
    <description>Percentage of patients with correctly predicted outcomes using HostDx Sepsis (30-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.</measure>
    <time_frame>Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year</time_frame>
    <description>Percentage of patients with correctly predicted outcomes using HostDx Sepsis (90-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">200</enrollment>
  <condition>Sepsis</condition>
  <arm_group>
    <arm_group_label>Arm A</arm_group_label>
    <description>Patients with suspected sepsis at the time of admission to the ICU</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Arm B</arm_group_label>
    <description>Patients not currently suspected but at high risk for sepsis.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>HostDx Sepsis</intervention_name>
    <description>Blood collection for mRNA analysis</description>
    <arm_group_label>Arm A</arm_group_label>
    <arm_group_label>Arm B</arm_group_label>
  </intervention>
  <biospec_retention>Samples Without DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      The blood sample collection materials for the HostDx Sepsis test (PAXgene Blood RNA tubes)&#xD;
      will be collected. EDTA tubes for plasma measurements of procalcitonin and IL-6 will be&#xD;
      collected. Collection tubes for serum samples to measure viral antibodies and/or viral titers&#xD;
      (indicative of reactivation of viral infection) will also be collected. These will be stored&#xD;
      locally and processed at a later time point dependent on needs, i.e. suspicion of viral&#xD;
      reactivation.&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects admitted to the surgical ICU with suspected sepsis or at high risk for subsequent&#xD;
        sepsis onset.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Arm A&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. Suspected sepsis at the time of admission to the ICU&#xD;
&#xD;
          3. Direct admission from the ED to the ICU with suspected/proven sepsis.&#xD;
&#xD;
          4. Post-operative ICU admission after sepsis source control procedure&#xD;
&#xD;
          5. Inpatients admitted to the ICU from the ward with suspected sepsis onset.&#xD;
&#xD;
          6. Able to provide subject/proxy informed consent within 96h&#xD;
&#xD;
        Arm B&#xD;
&#xD;
          1. Age &gt; 18 years&#xD;
&#xD;
          2. No suspicion of sepsis at the time of admission to the ICU but at high risk for&#xD;
             subsequent sepsis onset&#xD;
&#xD;
          3. Non-trauma admission from the ED to the ICU&#xD;
&#xD;
          4. Post-operative ICU admission&#xD;
&#xD;
          5. Severe trauma admission from the ED (injury severity score &gt;15, hemorrhagic shock,&#xD;
             severe traumatic brain injury, and or severe chest trauma)&#xD;
&#xD;
          6. Inpatients admitted to the ICU from the ward for decompensation not initially&#xD;
             suspected to be secondary to sepsis.&#xD;
&#xD;
          7. Able to provide subject/proxy informed consent within 96h&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Pre- or post-transplant patients&#xD;
&#xD;
          2. Patients admitted solely for airway monitoring, or vascular/flap check monitoring&#xD;
&#xD;
          3. Previous diagnosis of sepsis on index hospitalization.&#xD;
&#xD;
          4. Unable to provide informed consent within 96h&#xD;
&#xD;
          5. Previously enrolled in the present study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>University of Florida College of Medicine</name>
      <address>
        <city>Gainesville</city>
        <state>Florida</state>
        <zip>32610</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>May 22, 2020</study_first_submitted>
  <study_first_submitted_qc>May 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 4, 2020</study_first_posted>
  <last_update_submitted>December 7, 2021</last_update_submitted>
  <last_update_submitted_qc>December 7, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 22, 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>Sepsis</mesh_term>
    <mesh_term>Toxemia</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/NCT04414189
org study id: INF-06
nct id: NCT04414189
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will analyze HostDx Sepsis results from whole blood samples collected from
      patients with suspected sepsis or at risk for sepsis in the surgical ICU
observational model: Case-Only
time perspective: Prospective
measure: Validate the diagnostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
description: Percentage of correctly identified patients with bacterial and/or viral infections using HostDx Sepsis compared to clinical adjudications using routine clinical, laboratory, and other findings
measure: Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
description: Percentage of patients with correctly predicted outcomes using HostDx Sepsis (7-day organ support), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
measure: Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
description: Percentage of patients with correctly predicted outcomes using HostDx Sepsis (CCI), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
measure: Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
description: Percentage of patients with correctly predicted outcomes using HostDx Sepsis (30-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
measure: Validate the prognostic accuracy of HostDx Sepsis in a cohort of 360 hospitalized patients enrolled at time of suspicion of sepsis or at high risk for developing sepsis.
time frame: Time to enroll 360 subjects, process samples, and complete the follow-up, an average of 1 year
description: Percentage of patients with correctly predicted outcomes using HostDx Sepsis (90-day mortality), and agreement between observed likelihood ratios and target likelihood ratios for the interpretation bands in HostDx Sepsis
arm group label: Arm A
description: Patients with suspected sepsis at the time of admission to the ICU
arm group label: Arm B
description: Patients not currently suspected but at high risk for sepsis.
intervention type: Diagnostic Test
intervention name: HostDx Sepsis
description: Blood collection for mRNA analysis
arm group label: Arm A
arm group label: Arm B
The blood sample collection materials for the HostDx Sepsis test (PAXgene Blood RNA tubes)
      will be collected. EDTA tubes for plasma measurements of procalcitonin and IL-6 will be
      collected. Collection tubes for serum samples to measure viral antibodies and/or viral titers
      (indicative of reactivation of viral infection) will also be collected. These will be stored
      locally and processed at a later time point dependent on needs, i.e. suspicion of viral
      reactivation.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: United States
responsible party type: Sponsor
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: No