<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/NCT01667172</url>
  </required_header>
  <id_info>
    <org_study_id>S54271</org_study_id>
    <nct_id>NCT01667172</nct_id>
  </id_info>
  <brief_title>Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices in Comparison With Laboratory CRP Testing.</brief_title>
  <official_title>Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein&#xD;
      devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.&#xD;
&#xD;
      Research questions:&#xD;
&#xD;
        1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP&#xD;
           values measured at the clinical laboratory?&#xD;
&#xD;
        2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable?&#xD;
           2.1.1. Comparison of 2 measurements in the same patient on 1 device&#xD;
           (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on&#xD;
           2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices&#xD;
           equally userfriendly in a general practice surgery? (userfriendliness&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2012</start_date>
  <completion_date type="Actual">June 2012</completion_date>
  <primary_completion_date type="Actual">June 2012</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>technical accuracy</measure>
    <time_frame>3 months</time_frame>
    <description>correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>User-friendliness</measure>
    <time_frame>3 months</time_frame>
    <description>evaluation of the userfriendliness by General Practitioners at 5 practices, on a five point Likert-scale scoring these criteria: device start-up, test duration, sample size, test characteristics, calibration, measuring range, handling of test tubes, filling of the capillary, placing the test cartridge, test recording and additional material usage. The median results are compared between both devices qualitatively.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-device variability</measure>
    <time_frame>3 months</time_frame>
    <description>The inter-device-variability (by 1 physician) was tested on 10 patients in one General Practice surgery each on two different Point-of-Care devices of the same brand.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inter-observer variability</measure>
    <time_frame>3 months</time_frame>
    <description>The inter-observer variability (by two physicians) was tested on 10 patients in one GP surgery on two different Point-of-care devices of the same brand.</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">300</enrollment>
  <condition>Healthy and Acutely Ill Children &amp; Adults</condition>
  <arm_group>
    <arm_group_label>point-of-care test for CRP</arm_group_label>
    <arm_group_type>Other</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Point-of-Care C Reactive Protein measurement on capillary blood</intervention_name>
    <description>capillary blood fingerstick method to determine C Reactive Protein level in the blood</description>
    <arm_group_label>point-of-care test for CRP</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  children: aged 1 month to 14 years&#xD;
&#xD;
          -  adults: aged 18-65 years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  children and adults not understanding Dutch language&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>1 Month</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Huisartspraktijken</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Medisch Centrum voor Huisartsen</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>UZ Leuven</name>
      <address>
        <city>Leuven</city>
        <state>Vlaams-Brabant</state>
        <zip>3000</zip>
        <country>Belgium</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Belgium</country>
  </location_countries>
  <reference>
    <citation>Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082.</citation>
    <PMID>21653621</PMID>
  </reference>
  <reference>
    <citation>Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2.</citation>
    <PMID>20132979</PMID>
  </reference>
  <verification_date>August 2012</verification_date>
  <study_first_submitted>August 14, 2012</study_first_submitted>
  <study_first_submitted_qc>August 15, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 17, 2012</study_first_posted>
  <last_update_submitted>August 15, 2012</last_update_submitted>
  <last_update_submitted_qc>August 15, 2012</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 17, 2012</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>KU Leuven</investigator_affiliation>
    <investigator_full_name>Jan Verbakel</investigator_full_name>
    <investigator_title>Research Assistant</investigator_title>
  </responsible_party>
  <!-- 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/NCT01667172
org study id: S54271
nct id: NCT01667172
lead sponsor: 
has dmc: No
Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein
      devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.

      Research questions:

        1. Are the POC CRP devices technically accurate? Do the measured values agree with CRP
           values measured at the clinical laboratory?

        2. Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable?
           2.1.1. Comparison of 2 measurements in the same patient on 1 device
           (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on
           2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices
           equally userfriendly in a general practice surgery? (userfriendliness
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Diagnostic
masking: Double (Participant, Care Provider)
measure: technical accuracy
time frame: 3 months
description: correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory
measure: User-friendliness
time frame: 3 months
description: evaluation of the userfriendliness by General Practitioners at 5 practices, on a five point Likert-scale scoring these criteria: device start-up, test duration, sample size, test characteristics, calibration, measuring range, handling of test tubes, filling of the capillary, placing the test cartridge, test recording and additional material usage. The median results are compared between both devices qualitatively.
measure: Inter-device variability
time frame: 3 months
description: The inter-device-variability (by 1 physician) was tested on 10 patients in one General Practice surgery each on two different Point-of-Care devices of the same brand.
measure: Inter-observer variability
time frame: 3 months
description: The inter-observer variability (by two physicians) was tested on 10 patients in one GP surgery on two different Point-of-care devices of the same brand.
arm group label: point-of-care test for CRP
arm group type: Other
intervention type: Device
intervention name: Point-of-Care C Reactive Protein measurement on capillary blood
description: capillary blood fingerstick method to determine C Reactive Protein level in the blood
arm group label: point-of-care test for CRP
criteria: 
gender: All
minimum age: 1 Month
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
facility: 
facility: 
country: Belgium
citation: Van den Bruel A, Thompson MJ, Haj-Hassan T, Stevens R, Moll H, Lakhanpaul M, Mant D. Diagnostic value of laboratory tests in identifying serious infections in febrile children: systematic review. BMJ. 2011 Jun 8;342:d3082. doi: 10.1136/bmj.d3082.
PMID: 21653621
citation: Van den Bruel A, Haj-Hassan T, Thompson M, Buntinx F, Mant D; European Research Network on Recognising Serious Infection investigators. Diagnostic value of clinical features at presentation to identify serious infection in children in developed countries: a systematic review. Lancet. 2010 Mar 6;375(9717):834-45. doi: 10.1016/S0140-6736(09)62000-6. Epub 2010 Feb 2.
PMID: 20132979
responsible party type: Principal Investigator
investigator affiliation: KU Leuven
investigator full name: Jan Verbakel
investigator title: Research Assistant