<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/NCT03752476</url>
  </required_header>
  <id_info>
    <org_study_id>Dossot</org_study_id>
    <nct_id>NCT03752476</nct_id>
  </id_info>
  <brief_title>Impact of Number of Rank of B-lactam Antibiotics on Emergence on Multidrug Resistant Bacteria</brief_title>
  <acronym>INOR Blact</acronym>
  <official_title>Impact of Number of Rank of B-lactam Antibiotics on Emergence on Multidrug Resistant Bacteria</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Universitaire de Besancon</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Universitaire de Besancon</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 evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug&#xD;
      resistant bacteria colonization in intensive care&#xD;
&#xD;
      It's retrospective case controle study. Cases are colonized patient by multidrug resistant&#xD;
      bacteria hospitalized in intensive care during the fist hospitalization in intensive care.&#xD;
      Temoin are patients with the same characteristics than case but no colonized by multidrug&#xD;
      resistant bacteria.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The emergence of multidrug resistant is a wordwide problem. B lactam resistant increase. The&#xD;
      antibiotic prescription impact this problem.&#xD;
&#xD;
      B lactam antibiotic is prescribed everyday in intensive care unit. The switch of antibiotic&#xD;
      is common. Antibiotic classes inclue a lot of rank with different spectum that impact the&#xD;
      occurrence of resistant.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">January 1, 2019</start_date>
  <completion_date type="Anticipated">May 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">May 1, 2019</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>number of Beta lactam class prescription</measure>
    <time_frame>3 months</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">1300</enrollment>
  <condition>Resistant Infection</condition>
  <condition>Antibiotic Resistant Infection</condition>
  <condition>Beta Lactam Resistant Bacterial Infection</condition>
  <condition>Bacterial Resistance</condition>
  <arm_group>
    <arm_group_label>case</arm_group_label>
    <description>Patients are colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <description>Patients aren't colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>number of Beta lactam class prescription for the same infection</intervention_name>
    <description>Each number of Beta lactam prescription without interruption are compared</description>
    <arm_group_label>case</arm_group_label>
    <arm_group_label>control</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        all patient hospitalized more than 48 hours in intensive care unit in Besançon between&#xD;
        january 2016 and december 2017&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  all patient hospitalized more than 48 hours in intensive care unit in Besançon between&#xD;
             january 2016 and december 2017&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patient under guardianship&#xD;
&#xD;
          -  patient allergic to Beta lactam&#xD;
&#xD;
          -  colonization with mutidrug resistant the first week of hospitalization in intensive&#xD;
             care unit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>100 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>ESTELLE DOSSOT</last_name>
    <phone>+33645578372</phone>
    <email>estelle.dossot@gmail.com</email>
  </overall_contact>
  <verification_date>November 2018</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 21, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 26, 2018</study_first_posted>
  <last_update_submitted>November 21, 2018</last_update_submitted>
  <last_update_submitted_qc>November 21, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">November 26, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Centre Hospitalier Universitaire de Besancon</investigator_affiliation>
    <investigator_full_name>Estelle Dossot</investigator_full_name>
    <investigator_title>Internal</investigator_title>
  </responsible_party>
  <keyword>antibiotic resistant</keyword>
  <keyword>multidrug resistant</keyword>
  <keyword>Beta lactam</keyword>
  <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>Bacterial Infections</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lactams</mesh_term>
    <mesh_term>beta-Lactams</mesh_term>
  </intervention_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/NCT03752476
org study id: Dossot
nct id: NCT03752476
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates the impact of rank of Beta lactam antibiotics on emergence of mutlidrug
      resistant bacteria colonization in intensive care

      It's retrospective case controle study. Cases are colonized patient by multidrug resistant
      bacteria hospitalized in intensive care during the fist hospitalization in intensive care.
      Temoin are patients with the same characteristics than case but no colonized by multidrug
      resistant bacteria.
The emergence of multidrug resistant is a wordwide problem. B lactam resistant increase. The
      antibiotic prescription impact this problem.

      B lactam antibiotic is prescribed everyday in intensive care unit. The switch of antibiotic
      is common. Antibiotic classes inclue a lot of rank with different spectum that impact the
      occurrence of resistant.
observational model: Case-Control
time perspective: Retrospective
measure: number of Beta lactam class prescription
time frame: 3 months
arm group label: case
description: Patients are colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017.
arm group label: control
description: Patients aren't colonized patient by antimicrobial bacteria hospitalized in intensive care during the fist hospitalization in intensive care during 2016-2017.
intervention type: Procedure
intervention name: number of Beta lactam class prescription for the same infection
description: Each number of Beta lactam prescription without interruption are compared
arm group label: case
arm group label: control
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: 100 Years
healthy volunteers: Accepts Healthy Volunteers
last name: ESTELLE DOSSOT
phone: +33645578372
email: estelle.dossot@gmail.com
responsible party type: Principal Investigator
investigator affiliation: Centre Hospitalier Universitaire de Besancon
investigator full name: Estelle Dossot
investigator title: Internal
mesh term: Infections
mesh term: Communicable Diseases
mesh term: Bacterial Infections
mesh term: Lactams
mesh term: beta-Lactams
sharing ipd: No