<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/NCT03835104</url>
  </required_header>
  <id_info>
    <org_study_id>S61991</org_study_id>
    <nct_id>NCT03835104</nct_id>
  </id_info>
  <brief_title>ERNIE4: Urine and CRP Point-of-care Test in Acutely Ill Children</brief_title>
  <acronym>ERNIE4</acronym>
  <official_title>Urine and CRP Tests at the Point-of-care for the Diagnostic Assessment of Acutely Ill Children: a Diagnostic and Prognostic Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>KU Leuven</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>KU Leuven</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 aims to assess the accuracy of a novel urine test for diagnosing urinary tract&#xD;
      infections in acutely ill children presenting to ambulatory care. The accuracy of this novel&#xD;
      test will be compared to the accuracy of conventional dipstick testing. In addition, the&#xD;
      evidence on urine tests will be added to the existing algorithm for diagnosing serious&#xD;
      infections in children. Finally, the study aims to describe the relation between the CRP&#xD;
      level at study entry and the duration of symptoms and final diagnosis over the following 30&#xD;
      days.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely&#xD;
      children presenting to ambulatory care.&#xD;
&#xD;
      The cross-sectional cohort study will compare an innovative urine test with conventional&#xD;
      dipstick testing to establish their relative accuracy to diagnose urinary tract infections,&#xD;
      and construct an algorithm consisting of clinical features, urine test results and CRP&#xD;
      point-of-care testing to identify serious infections. The longitudinal follow-up study will&#xD;
      describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at&#xD;
      first contact.&#xD;
&#xD;
      The study will run in general practices and community paediatrics in Flanders. Recruitment to&#xD;
      the study is expected to last 18 months, with each patient entering the study only once.&#xD;
      Children and their parents/guardians will be approached for possible participation in the&#xD;
      study by practice staff. There is only one study visit.&#xD;
&#xD;
      Those who agree to participation via written informed consent will have demographics and&#xD;
      clinical features recorded. All children will be asked to provide a urine sample on study&#xD;
      entry. Subsequently, CRP point-of-care testing will be conducted in all children testing&#xD;
      positive on a clinical prediction rule, and in a random sample of children testing negative&#xD;
      on that rule. Follow-up information for all children will be collected using general practice&#xD;
      notes, hospital records and direct patient/parent contact.&#xD;
&#xD;
      Treatment and other management decisions will be left to the treating physicians' discretion.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Covid pandemic caused recruitment to stop&#xD;
  </why_stopped>
  <start_date type="Actual">February 12, 2019</start_date>
  <completion_date type="Actual">May 22, 2020</completion_date>
  <primary_completion_date type="Actual">May 22, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>The study is a cluster randomized controlled trial. The general practice is the unit of cluster.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Urinary tract infection</measure>
    <time_frame>3 days</time_frame>
    <description>The number of children with a urinary tract infection based on urine culture</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Serious infections</measure>
    <time_frame>30 days</time_frame>
    <description>The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Final diagnosis</measure>
    <time_frame>30 days</time_frame>
    <description>For children not admitted to hospital, the final diagnosis based on all available clinical information from ambulatory care assessment over 30 days after the index date.</description>
  </other_outcome>
  <other_outcome>
    <measure>Duration of symptoms</measure>
    <time_frame>30 days</time_frame>
    <description>For all children, the duration of symptoms after the index date based on patient diaries</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare resource use</measure>
    <time_frame>30 days</time_frame>
    <description>For all children, re-consultation rates in ambulatory care after the index date</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare resource use</measure>
    <time_frame>30 days</time_frame>
    <description>For all children, ED attendance after the index date</description>
  </other_outcome>
  <other_outcome>
    <measure>Healthcare resource use</measure>
    <time_frame>30 days</time_frame>
    <description>For all children, hospital admission after the index date</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">868</enrollment>
  <condition>Infection</condition>
  <arm_group>
    <arm_group_label>CRP in all</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>All children will undergo a CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott).&#xD;
There will be only 1 test at study entry</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CRP in high risk children only</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Children who are positive on a clinical prediction rule for serious infections in children will undergo CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott).&#xD;
There will be only 1 test at study entry</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>CRP point-of-care testing</intervention_name>
    <description>CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)</description>
    <arm_group_label>CRP in all</arm_group_label>
    <arm_group_label>CRP in high risk children only</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Aged 3 months to 18 years&#xD;
&#xD;
          -  Presenting to a general practice or community paediatrics&#xD;
&#xD;
          -  Acute illness of a maximum of 10 days&#xD;
&#xD;
          -  Parent or guardian is willing and able to give informed consent for participation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Clinically unstable warranting immediate care&#xD;
&#xD;
          -  Urinary catheter in situ&#xD;
&#xD;
          -  Immunosuppressant medication taken in the previous 30 days&#xD;
&#xD;
          -  Trauma is the main presenting problem&#xD;
&#xD;
          -  Antibiotics taken in the previous 7 days&#xD;
&#xD;
          -  Children who present to community paediatrics as a result of direct GP referral&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>3 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ann Van den Bruel, MD PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ACHG, KU Leuven</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>KU Leuven</name>
      <address>
        <city>Leuven</city>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <verification_date>May 2021</verification_date>
  <study_first_submitted>January 29, 2019</study_first_submitted>
  <study_first_submitted_qc>February 7, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 8, 2019</study_first_posted>
  <last_update_submitted>May 31, 2021</last_update_submitted>
  <last_update_submitted_qc>May 31, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 3, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Ann Van den Bruel</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>diagnosis</keyword>
  <keyword>sensitivity and specificity</keyword>
  <keyword>serious infections</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Any invitations for data sharing will be assessed on scientific validity, after which a decision will be taken.</ipd_description>
  </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/NCT03835104
org study id: S61991
nct id: NCT03835104
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to assess the accuracy of a novel urine test for diagnosing urinary tract
      infections in acutely ill children presenting to ambulatory care. The accuracy of this novel
      test will be compared to the accuracy of conventional dipstick testing. In addition, the
      evidence on urine tests will be added to the existing algorithm for diagnosing serious
      infections in children. Finally, the study aims to describe the relation between the CRP
      level at study entry and the duration of symptoms and final diagnosis over the following 30
      days.
The design is a cross-sectional cohort study with a nested longitudinal follow-up in acutely
      children presenting to ambulatory care.

      The cross-sectional cohort study will compare an innovative urine test with conventional
      dipstick testing to establish their relative accuracy to diagnose urinary tract infections,
      and construct an algorithm consisting of clinical features, urine test results and CRP
      point-of-care testing to identify serious infections. The longitudinal follow-up study will
      describe illness trajectories of children with an intermediate CRP test result (5-80 mg/L) at
      first contact.

      The study will run in general practices and community paediatrics in Flanders. Recruitment to
      the study is expected to last 18 months, with each patient entering the study only once.
      Children and their parents/guardians will be approached for possible participation in the
      study by practice staff. There is only one study visit.

      Those who agree to participation via written informed consent will have demographics and
      clinical features recorded. All children will be asked to provide a urine sample on study
      entry. Subsequently, CRP point-of-care testing will be conducted in all children testing
      positive on a clinical prediction rule, and in a random sample of children testing negative
      on that rule. Follow-up information for all children will be collected using general practice
      notes, hospital records and direct patient/parent contact.

      Treatment and other management decisions will be left to the treating physicians' discretion.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: The study is a cluster randomized controlled trial. The general practice is the unit of cluster.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Urinary tract infection
time frame: 3 days
description: The number of children with a urinary tract infection based on urine culture
measure: Serious infections
time frame: 30 days
description: The number of children admitted to hospital for a serious infection which can be pneumonia, sepsis, meningitis, pyelonephritis, osteomyelitis or appendicitis
measure: Final diagnosis
time frame: 30 days
description: For children not admitted to hospital, the final diagnosis based on all available clinical information from ambulatory care assessment over 30 days after the index date.
measure: Duration of symptoms
time frame: 30 days
description: For all children, the duration of symptoms after the index date based on patient diaries
measure: Healthcare resource use
time frame: 30 days
description: For all children, re-consultation rates in ambulatory care after the index date
measure: Healthcare resource use
time frame: 30 days
description: For all children, ED attendance after the index date
measure: Healthcare resource use
time frame: 30 days
description: For all children, hospital admission after the index date
arm group label: CRP in all
arm group type: Active Comparator
description: All children will undergo a CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott).
There will be only 1 test at study entry
arm group label: CRP in high risk children only
arm group type: Experimental
description: Children who are positive on a clinical prediction rule for serious infections in children will undergo CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes using the Afinion 2 (Abbott).
There will be only 1 test at study entry
intervention type: Device
intervention name: CRP point-of-care testing
description: CRP point-of-care test using a fingerprick of blood and producing a result within 4 minutes, using the Afinion 2 (Abbott)
arm group label: CRP in all
arm group label: CRP in high risk children only
criteria: 
gender: All
minimum age: 3 Years
maximum age: 18 Years
healthy volunteers: No
last name: Ann Van den Bruel, MD PhD
role: Principal Investigator
affiliation: ACHG, KU Leuven
facility: 
country: Belgium
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Ann Van den Bruel
investigator title: Associate Professor
mesh term: Infections
sharing ipd: Undecided
ipd description: Any invitations for data sharing will be assessed on scientific validity, after which a decision will be taken.