<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/NCT03237403</url>
  </required_header>
  <id_info>
    <org_study_id>2017-A02335-48</org_study_id>
    <nct_id>NCT03237403</nct_id>
  </id_info>
  <brief_title>Hospital Orientation Since SAMU Regulation Centre Call</brief_title>
  <official_title>Study of Association Between Clinical Criteria Collected at the SAMU Regulation Centre Call and the Hospital Orientation of Patients With Suspected Sepsis State</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hôpital Necker-Enfants Malades</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hôpital Necker-Enfants Malades</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>
      Specify the association between clinical criteria transmitted by non-medical emergency&#xD;
      services to the regulation of the SAMU centre call in patients with suspected sepsis and&#xD;
      their hospital orientation: emergency department or intensive care unit&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Anonymous, descriptive, longitudinal, resting study searching an association between clinical&#xD;
      criteria transmitted by non-medical emergency services to the regulation of the SAMU centre&#xD;
      call for patients with suspected sepsis and their subsequent hospital orientation&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2017</start_date>
  <completion_date type="Anticipated">January 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Retrospective</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Hospital Admission Service</measure>
    <time_frame>1 day</time_frame>
    <description>Emergency department or intensive care unit</description>
  </primary_outcome>
  <enrollment type="Anticipated">1000</enrollment>
  <condition>Sepsis</condition>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>observational study</intervention_name>
    <description>observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation</description>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        All subjects calling the SAMU regulation centre call with a clinical suspected sepsis&#xD;
        history&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  adults (age&gt;18years)&#xD;
&#xD;
          -  patients with suspected sepsis state at the regulation SAMU centre call&#xD;
&#xD;
        Exclusion Criteria: minor (age&lt;18years)&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Romain Jouffroy, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>APHP Necker Enfants Malades SAMU 75</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Romain Jouffroy, MD</last_name>
    <phone>+3314495989</phone>
    <email>romain.jouffroy@aphp.fr</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Benoit Vivien, MD, PhD</last_name>
    <phone>+33144492424</phone>
    <email>benoit.vivien@aphp.fr</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>APHP Necker Enfants Malades</name>
      <address>
        <city>Paris</city>
        <zip>75015</zip>
        <country>France</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Romain Jouffroy, MD</last_name>
      <phone>+3314495989</phone>
      <email>romain.jouffroy@aphp.fr</email>
    </contact>
    <contact_backup>
      <last_name>Benoit Vivien, MD, PhD</last_name>
      <phone>+33144492424</phone>
      <email>benoit.vivien@aphp.fr</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>July 31, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 2, 2017</study_first_posted>
  <last_update_submitted>August 1, 2017</last_update_submitted>
  <last_update_submitted_qc>August 1, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 3, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hôpital Necker-Enfants Malades</investigator_affiliation>
    <investigator_full_name>Romain Jouffroy</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>Adults</keyword>
  <keyword>Pre hospital settings</keyword>
  <keyword>Triage</keyword>
  <keyword>Hospital orientation</keyword>
  <keyword>Outcome</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Sepsis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>No IPD sharing plan is planned</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/NCT03237403
org study id: 2017-A02335-48
nct id: NCT03237403
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Specify the association between clinical criteria transmitted by non-medical emergency
      services to the regulation of the SAMU centre call in patients with suspected sepsis and
      their hospital orientation: emergency department or intensive care unit
Anonymous, descriptive, longitudinal, resting study searching an association between clinical
      criteria transmitted by non-medical emergency services to the regulation of the SAMU centre
      call for patients with suspected sepsis and their subsequent hospital orientation
observational model: Cohort
time perspective: Retrospective
measure: Hospital Admission Service
time frame: 1 day
description: Emergency department or intensive care unit
intervention type: Other
intervention name: observational study
description: observational study between clinical criteria collected at SAMU regulation centre call and hospital orientation
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Romain Jouffroy, MD
role: Principal Investigator
affiliation: APHP Necker Enfants Malades SAMU 75
last name: Romain Jouffroy, MD
phone: +3314495989
email: romain.jouffroy@aphp.fr
last name: Benoit Vivien, MD, PhD
phone: +33144492424
email: benoit.vivien@aphp.fr
facility: 
status: Recruiting
contact: 
contact backup: 
country: France
responsible party type: Principal Investigator
investigator affiliation: Hôpital Necker-Enfants Malades
investigator full name: Romain Jouffroy
investigator title: Principal Investigator
mesh term: Sepsis
sharing ipd: No
ipd description: No IPD sharing plan is planned