<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/NCT02988414</url>
  </required_header>
  <id_info>
    <org_study_id>005-CL-01</org_study_id>
    <nct_id>NCT02988414</nct_id>
  </id_info>
  <brief_title>Diagnosis of Bacteremia/Septicemia and Culture Negative Endocarditis by the Karius Sequencing-Based Infectious Disease Diagnostic Assay</brief_title>
  <official_title>Diagnosis of Bacteremia/Septicemia by the Karius Sequencing-Based Infectious Disease Diagnostic Assay</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Karius, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Duke University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Karius, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Prospective study at Duke University Hospital comparing the Karius Infectious Disease&#xD;
      Diagnostic Sequencing Assay to blood culture results in admitted patients with&#xD;
      bacteremia/septicemia.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2016</start_date>
  <completion_date type="Actual">April 2017</completion_date>
  <primary_completion_date type="Actual">April 2017</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>Other</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia</measure>
    <time_frame>12 months</time_frame>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">108</enrollment>
  <condition>Bacteremia</condition>
  <condition>Septicemia</condition>
  <arm_group>
    <arm_group_label>Staphylococcus aureus Infection</arm_group_label>
    <description>Patients with blood culture confirmed S. aureus bloodstream infections.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Gram Negative Infection</arm_group_label>
    <description>Patients with blood culture confirmed Gram Negative bloodstream infecrions</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Endocarditis</arm_group_label>
    <description>Patients admitted for evaluation of acute endocarditis classified using the Duke Criteria.</description>
  </arm_group>
  <biospec_retention>Samples With DNA</biospec_retention>
  <biospec_descr>
    <textblock>
      Plasma&#xD;
    </textblock>
  </biospec_descr>
  <eligibility>
    <study_pop>
      <textblock>
        Subjects who are at least 18 years of age, have been admitted to Duke University Hospital,&#xD;
        and have a positive blood culture.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. 18 years or older&#xD;
&#xD;
          2. A positive blood culture&#xD;
&#xD;
          3. A suitable residual blood sample collected within 24 hours of the positive blood&#xD;
             culture OR&#xD;
&#xD;
          4. A blood sample obtained for the study obtain within 48 hours of the positive blood&#xD;
             culture&#xD;
&#xD;
        For Endocarditis Cohort:&#xD;
&#xD;
        1. All criteria above must be met and patient is admitted to the hospital and evaluated for&#xD;
        acute endocarditis classified per the Duke Criteria&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Inability to understand instructions and comply with study-related procedures&#xD;
&#xD;
          2. Any condition that in the opinion of the treating physician will prevent the subject&#xD;
             from completing the 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>
  <overall_official>
    <last_name>Vance G Fowler, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Duke University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Duke University Hospital</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27710</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>April 2017</verification_date>
  <study_first_submitted>December 7, 2016</study_first_submitted>
  <study_first_submitted_qc>December 7, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 9, 2016</study_first_posted>
  <last_update_submitted>May 7, 2018</last_update_submitted>
  <last_update_submitted_qc>May 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>Infection</keyword>
  <keyword>Culture</keyword>
  <keyword>Sequencing</keyword>
  <keyword>Non-invasive</keyword>
  <keyword>NGS</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Infections</mesh_term>
    <mesh_term>Bacteremia</mesh_term>
    <mesh_term>Sepsis</mesh_term>
    <mesh_term>Toxemia</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT02988414
org study id: 005-CL-01
nct id: NCT02988414
lead sponsor: 
collaborator: 
has dmc: No
Prospective study at Duke University Hospital comparing the Karius Infectious Disease
      Diagnostic Sequencing Assay to blood culture results in admitted patients with
      bacteremia/septicemia.
observational model: Cohort
time perspective: Other
measure: Sensitivity, specificity, positive predictive value, and negative predictive value of the Karius test compared with blood culture in patients with bacteremia/septicemia
time frame: 12 months
arm group label: Staphylococcus aureus Infection
description: Patients with blood culture confirmed S. aureus bloodstream infections.
arm group label: Gram Negative Infection
description: Patients with blood culture confirmed Gram Negative bloodstream infecrions
arm group label: Endocarditis
description: Patients admitted for evaluation of acute endocarditis classified using the Duke Criteria.
Plasma
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Vance G Fowler, MD
role: Principal Investigator
affiliation: Duke University
facility: 
country: United States
responsible party type: Sponsor
mesh term: Communicable Diseases
mesh term: Infections
mesh term: Bacteremia
mesh term: Sepsis
mesh term: Toxemia
sharing ipd: Undecided