<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/NCT04448548</url>
  </required_header>
  <id_info>
    <org_study_id>MDW</org_study_id>
    <nct_id>NCT04448548</nct_id>
  </id_info>
  <brief_title>Possible Roles of MDW in Infection Management in Emergency Care</brief_title>
  <official_title>Possible Roles of MDW in Infection Management in Emergency Care</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Szeged University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Szeged University</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>
      A retrospective study to determine the potential value of MDW among other biomarkers in the&#xD;
      diagnosis of infection.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      MDW as a novel indicator can be useful in clinical practice in the emergency care. However,&#xD;
      until now, no study has been published about MDW's general relationship and coherence with&#xD;
      multiple, conventional laboratory tests for infections, such as PCT, C-reactive protein&#xD;
      (CRP), WBC, neutrophil count (NC), neutrophil percentage and immature granulocyte count (IGC)&#xD;
      together.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 1, 2019</start_date>
  <completion_date type="Actual">January 31, 2020</completion_date>
  <primary_completion_date type="Actual">January 31, 2020</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>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>MDW cutoff value for infection</measure>
    <time_frame>4 months</time_frame>
    <description>Cutoff value for MDW indicating infection</description>
  </primary_outcome>
  <enrollment type="Actual">300</enrollment>
  <condition>Infection</condition>
  <condition>Sepsis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>blood sample taking</intervention_name>
    <description>For study purposes, blood sample was taken during the first medical examination from patients with suspected infection.</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        adult (18+ years), receiving care for suspected infection&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adult (18+ years), receiving care for suspected infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  refuses to sign the consent form&#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 Szeged, Emergency Department</name>
      <address>
        <city>Szeged</city>
        <country>Hungary</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Hungary</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 24, 2020</study_first_submitted>
  <study_first_submitted_qc>June 24, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 26, 2020</study_first_posted>
  <last_update_submitted>June 24, 2020</last_update_submitted>
  <last_update_submitted_qc>June 24, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 26, 2020</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>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
    <mesh_term>Emergencies</mesh_term>
  </condition_browse>
  <!-- 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/NCT04448548
org study id: MDW
nct id: NCT04448548
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A retrospective study to determine the potential value of MDW among other biomarkers in the
      diagnosis of infection.
MDW as a novel indicator can be useful in clinical practice in the emergency care. However,
      until now, no study has been published about MDW's general relationship and coherence with
      multiple, conventional laboratory tests for infections, such as PCT, C-reactive protein
      (CRP), WBC, neutrophil count (NC), neutrophil percentage and immature granulocyte count (IGC)
      together.
observational model: Case-Only
time perspective: Retrospective
measure: MDW cutoff value for infection
time frame: 4 months
description: Cutoff value for MDW indicating infection
intervention type: Other
intervention name: blood sample taking
description: For study purposes, blood sample was taken during the first medical examination from patients with suspected infection.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: Hungary
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Emergencies