<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/NCT03025672</url>
  </required_header>
  <id_info>
    <org_study_id>OBS-021</org_study_id>
    <nct_id>NCT03025672</nct_id>
  </id_info>
  <brief_title>Evaluation of the Cost of a Nosocomial Infection With Clostridium Difficile</brief_title>
  <sponsors>
    <lead_sponsor>
      <agency>Lille Catholic University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Lille Catholic University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode&#xD;
      of transmission and its resistance in the environment.&#xD;
&#xD;
      Nosocomiality is defined by the apparition of an infection 48 hours after the patient's&#xD;
      hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted&#xD;
      directly through the hand or from the contaminated environment (during care or not). By&#xD;
      implementing prevention and optimal treatment, nosocomial infections are preventable.&#xD;
&#xD;
      A clostridium difficile infection causes an additional cost of patient care for the hospital.&#xD;
      This additional cost is principally due to the increase of the length of the stay. It varies&#xD;
      according to patient risk factors,and also according to the reason of the hospitalization and&#xD;
      can vary from 300 euros (~317$) to more than 25.000 euros (26.460$).&#xD;
&#xD;
      By determining the increase in the length of the stay and the additional cost due to a&#xD;
      clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut&#xD;
      Catholique de Lille), prevention will be valued and measures against those infections should&#xD;
      be easier to set up.&#xD;
&#xD;
      The main objective of this study is to evaluate the additional cost of an infection by&#xD;
      clostridium difficile.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>April 2015</start_date>
  <completion_date type="Actual">January 2017</completion_date>
  <primary_completion_date type="Actual">January 2017</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Control</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Difference between patient cost and income for the hospital based on the PMSI rate.</measure>
    <time_frame>Day 1</time_frame>
    <description>The difference between the real cost of the patient stay, included the additional costs due to clostridium difficile infection, and the public funding (calculated using the PMSI) for this stay will be computed.</description>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Actual">10445</enrollment>
  <condition>Cross Infection</condition>
  <condition>Clostridium Difficile Infection</condition>
  <arm_group>
    <arm_group_label>clostridium difficile</arm_group_label>
    <description>Patients that have been infected by clostridium difficile during their stay in hospital</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no clostridium difficile</arm_group_label>
    <description>Patients that have not been infected during their stay in hospital.</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Patients that have stayed in an hospital of the GHICL in 2013 and 2014&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients that have stayed in an hospital of the GHICL between January 2013 and&#xD;
             September 2015.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  none&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 10, 2017</study_first_submitted>
  <study_first_submitted_qc>January 16, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 19, 2017</study_first_posted>
  <last_update_submitted>January 16, 2017</last_update_submitted>
  <last_update_submitted_qc>January 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 19, 2017</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>Clostridium Infections</mesh_term>
    <mesh_term>Cross Infection</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03025672
org study id: OBS-021
nct id: NCT03025672
lead sponsor: 
has dmc: Yes
Clostridium difficile is the first cause of nosocomial infectious diarrhea, due to its mode
      of transmission and its resistance in the environment.

      Nosocomiality is defined by the apparition of an infection 48 hours after the patient's
      hospitalization. Clostridium difficile contamination occurs oro-fecally and is transmitted
      directly through the hand or from the contaminated environment (during care or not). By
      implementing prevention and optimal treatment, nosocomial infections are preventable.

      A clostridium difficile infection causes an additional cost of patient care for the hospital.
      This additional cost is principally due to the increase of the length of the stay. It varies
      according to patient risk factors,and also according to the reason of the hospitalization and
      can vary from 300 euros (~317$) to more than 25.000 euros (26.460$).

      By determining the increase in the length of the stay and the additional cost due to a
      clostridium difficile infection in the GHICL (Groupement des Hôpitaux de l'Institut
      Catholique de Lille), prevention will be valued and measures against those infections should
      be easier to set up.

      The main objective of this study is to evaluate the additional cost of an infection by
      clostridium difficile.
observational model: Case-Control
time perspective: Retrospective
measure: Difference between patient cost and income for the hospital based on the PMSI rate.
time frame: Day 1
description: The difference between the real cost of the patient stay, included the additional costs due to clostridium difficile infection, and the public funding (calculated using the PMSI) for this stay will be computed.
arm group label: clostridium difficile
description: Patients that have been infected by clostridium difficile during their stay in hospital
arm group label: no clostridium difficile
description: Patients that have not been infected during their stay in hospital.
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
responsible party type: Sponsor
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Clostridium Infections
mesh term: Cross Infection
sharing ipd: No