xml: <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/NCT06036758</url>
    </required_header>
    <id_info>
      <org_study_id>B3166-CTPR02</org_study_id>
      <nct_id>NCT06036758</nct_id>
    </id_info>
    <brief_title>VIDAS® NEPHROCLEAR Diagnostic Accuracy Study</brief_title>
    <official_title>VIDAS® NEPHROCLEAR CCL14 Diagnostic Accuracy Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>BioMérieux</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>BioMérieux</source>
    <oversight_info>
      <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>
        This is a multi-center sample analysis study in which urine samples previously collected from&#xD;
        persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to&#xD;
        validate the VIDAS® NEPHROCLEAR™ CCL14 Test&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical&#xD;
        evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI),&#xD;
        as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥&#xD;
        72 hours) within 48 hours of patient assessment.&#xD;
  &#xD;
        The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or&#xD;
        older.&#xD;
  &#xD;
        The objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™&#xD;
        CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative&#xD;
        predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative&#xD;
        risk (RR), will be evaluated at the pre-determined cut-off values.&#xD;
  &#xD;
        Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in&#xD;
        this study. The VIDAS® test results will be compared to the clinical AKI status established&#xD;
        by independent adjudication by medical professionals, that are blinded to the VIDAS® test&#xD;
        results.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">July 17, 2023</start_date>
    <completion_date type="Anticipated">October 30, 2023</completion_date>
    <primary_completion_date type="Anticipated">October 30, 2023</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>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Risk of developing persistent severe AKI</measure>
      <time_frame>Within 48 hours of ICU admittance</time_frame>
      <description>The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment</description>
    </primary_outcome>
    <number_of_groups>1</number_of_groups>
    <enrollment type="Anticipated">400</enrollment>
    <condition>Acute Kidney Injury</condition>
    <condition>Stage 2 Acute Kidney Injury</condition>
    <condition>Stage 3 Acute Kidney Injury</condition>
    <arm_group>
      <arm_group_label>Persons with Stage 2 to Stage 3 AKI</arm_group_label>
      <description>Persons with Stage 2 to Stage 3 AKI who are in the ICU.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>VIDAS® NEPHROCLEAR™ CCL14 Test</intervention_name>
      <description>Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test</description>
      <arm_group_label>Persons with Stage 2 to Stage 3 AKI</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Persons with Stage 2 to Stage 3 AKI&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  a) Males and females 21 years of age or older; b) Receiving care in an intensive care&#xD;
               unit; c) Expected to remain in the ICU for at least 48 hours after enrollment; d) Use&#xD;
               of indwelling urinary catheter as standard care at the time of enrollment; e) Subject&#xD;
               must have acute kidney injury (KDIGO Stage 2 or Stage 3) at the time of sample&#xD;
               collection; f) Urine sample must be collected within 36 hours of meeting KDIGO Stage 2&#xD;
               criteria; g) Documented informed consent provided by patient or legally authorized&#xD;
               representative (LAR).&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  a) Prior kidney transplantation; b) Comfort-measures-only status; c) Already receiving&#xD;
               dialysis (either acute or chronic) or in imminent need of dialysis at the time of&#xD;
               enrollment; d) Known infection with human immunodeficiency virus (HIV) or active&#xD;
               hepatitis (acute or chronic); (NOTE: HIV or hepatitis testing need not be performed&#xD;
               for enrollment in this study.) e) Special populations, pregnant women, prisoners or&#xD;
               institutionalized individuals;&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>George Washington University</name>
        <address>
          <city>Washington</city>
          <state>District of Columbia</state>
          <zip>20052</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location>
      <facility>
        <name>University of Illinois</name>
        <address>
          <city>Chicago</city>
          <state>Illinois</state>
          <zip>60612</zip>
          <country>United States</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 7, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</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>Acute Kidney Injury</mesh_term>
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06036758
  org study id: B3166-CTPR02
  nct id: NCT06036758
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: Yes
  is unapproved device: Yes
  is us export: No
  This is a multi-center sample analysis study in which urine samples previously collected from
        persons with Stage 2 or Stage 3 Acute Kidney Injury (AKI), will be tested in order to
        validate the VIDAS® NEPHROCLEAR™ CCL14 Test
  The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in conjunction with clinical
        evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI),
        as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥
        72 hours) within 48 hours of patient assessment.
  
        The VIDAS® NEPHROCLEAR™ CCL14 Test is intended to be used in patients 21 years of age or
        older.
  
        The objective of this study is to evaluate the diagnostic accuracy of the VIDAS® NEPHROCLEAR™
        CCL14 test when used on the VIDAS® 3 instrument. Sensitivity, specificity, negative
        predictive value (NPV), positive predictive value (PPV), likelihood ratios (LR), and relative
        risk (RR), will be evaluated at the pre-determined cut-off values.
  
        Previously collected urine samples from persons with Stage 2 to Stage 3 AKI will be tested in
        this study. The VIDAS® test results will be compared to the clinical AKI status established
        by independent adjudication by medical professionals, that are blinded to the VIDAS® test
        results.
  observational model: Cohort
  time perspective: Retrospective
  measure: Risk of developing persistent severe AKI
  time frame: Within 48 hours of ICU admittance
  description: The urine sample collected from ICU patients will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test, which is intended to be used in conjunction with clinical evaluation, in ICU patients with moderate to severe (stage 2 or 3) acute kidney injury (AKI), as an aid in the risk assessment for developing persistent severe AKI (stage 3 AKI lasting ≥ 72 hours) within 48 hours of patient assessment
  arm group label: Persons with Stage 2 to Stage 3 AKI
  description: Persons with Stage 2 to Stage 3 AKI who are in the ICU.
  intervention type: Diagnostic Test
  intervention name: VIDAS® NEPHROCLEAR™ CCL14 Test
  description: Urine samples previously collected from persons with stage 2/stage 3 AKI will be tested using the VIDAS® NEPHROCLEAR™ CCL14 Test
  arm group label: Persons with Stage 2 to Stage 3 AKI
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  facility: 
  country: United States
  responsible party type: Sponsor
  mesh term: Acute Kidney Injury
  mesh term: Wounds and Injuries
  sharing ipd: No