<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/NCT03280992</url>
  </required_header>
  <id_info>
    <org_study_id>35RC16_3024_CASC</org_study_id>
    <nct_id>NCT03280992</nct_id>
  </id_info>
  <brief_title>Community Acquired Sepsis Cohort</brief_title>
  <acronym>CASC</acronym>
  <official_title>Community Acquired Sepsis Cohort</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rennes University Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Rennes University Hospital</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>
      The aim of this project is to constitute a prospective cohort of all the patients presenting&#xD;
      to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic&#xD;
      syndrome of community origin.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications&#xD;
      of infectious diseases. In this context, the optimization of the management of septic&#xD;
      patients from their reception in the emergency services must be a priority. However there are&#xD;
      no predictors of progression or severity in patients admitted to emergencies despite the&#xD;
      recommendations emphasizing the need for screening and early therapeutic management. Many&#xD;
      scores have been proposed for intensive care unit but they remain difficult to extrapolate to&#xD;
      other services because they are very comprehensive and require information that is difficult&#xD;
      to obtain for emergency physicians.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Study not feasible in practise&#xD;
  </why_stopped>
  <start_date type="Actual">March 2, 2016</start_date>
  <completion_date type="Actual">August 27, 2018</completion_date>
  <primary_completion_date type="Actual">August 27, 2018</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>3 Months</target_duration>
  <primary_outcome>
    <measure>Assessment of morbidity in patients with septic syndrome of community origin</measure>
    <time_frame>Day 90</time_frame>
    <description>Study of prognostic factors</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Internal validity, severity score</measure>
    <time_frame>Day 90</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Internal validity, triage score by orientation nurses</measure>
    <time_frame>Day 90</time_frame>
  </primary_outcome>
  <primary_outcome>
    <measure>Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality</measure>
    <time_frame>Day 90</time_frame>
  </primary_outcome>
  <enrollment type="Actual">796</enrollment>
  <condition>Severe Septic Syndrome</condition>
  <condition>Septic Shock</condition>
  <eligibility>
    <study_pop>
      <textblock>
        Patient with a community infectious diseases&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient older than 18 years old&#xD;
&#xD;
          -  Patient hospitalized during the study period for community infectious diseases at the&#xD;
             CHU of Rennes&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Written objection from the patient to the computer processing of his data&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Persons subject to major legal protection (safeguarding justice, guardianship,&#xD;
             trusteeship), persons deprived of liberty&#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>CHU de Rennes</name>
      <address>
        <city>Rennes</city>
        <zip>35033</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>September 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 13, 2017</study_first_posted>
  <last_update_submitted>December 1, 2021</last_update_submitted>
  <last_update_submitted_qc>December 1, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 2, 2021</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>Shock, Septic</mesh_term>
    <mesh_term>Systemic Inflammatory Response Syndrome</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/NCT03280992
org study id: 35RC16_3024_CASC
nct id: NCT03280992
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this project is to constitute a prospective cohort of all the patients presenting
      to the adult emergencies of the University Hospital Centre (CHU) of Rennes for a septic
      syndrome of community origin.
Severe septic syndrome (SSG) and septic shock (CS) are two frequent and serious complications
      of infectious diseases. In this context, the optimization of the management of septic
      patients from their reception in the emergency services must be a priority. However there are
      no predictors of progression or severity in patients admitted to emergencies despite the
      recommendations emphasizing the need for screening and early therapeutic management. Many
      scores have been proposed for intensive care unit but they remain difficult to extrapolate to
      other services because they are very comprehensive and require information that is difficult
      to obtain for emergency physicians.
observational model: Cohort
time perspective: Prospective
measure: Assessment of morbidity in patients with septic syndrome of community origin
time frame: Day 90
description: Study of prognostic factors
measure: Internal validity, severity score
time frame: Day 90
measure: Internal validity, triage score by orientation nurses
time frame: Day 90
measure: Study of the prognostic factors of patients with septic syndrome of community origin in terms of mortality
time frame: Day 90
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
facility: 
country: France
responsible party type: Sponsor
mesh term: Shock, Septic
mesh term: Systemic Inflammatory Response Syndrome