<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/NCT03299894</url>
  </required_header>
  <id_info>
    <org_study_id>CHRO 2017-06</org_study_id>
    <nct_id>NCT03299894</nct_id>
  </id_info>
  <brief_title>Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department</brief_title>
  <acronym>qSOFAST</acronym>
  <official_title>Usefulness of Routine qSOFA Calculation at Triage to Fasten Antimicrobial Administration in Patients With Bacterial Infection in the Emergency Department: a Quasi-experimental Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Centre Hospitalier Régional d'Orléans</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Centre Hospitalier Régional d'Orléans</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 delayed administration of an adequate antimicrobial therapy is a strong predictor of&#xD;
      impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis&#xD;
      Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be&#xD;
      initiated within one hour following the recognition of sepsis or septic shock.&#xD;
&#xD;
      The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which&#xD;
      has been recently proposed by the Third International Sepsis Consensus Definitions Task Force&#xD;
      (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor&#xD;
      outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point&#xD;
      for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min)&#xD;
      and altered mentation (Glasgow coma scale &lt;15). The score ranges from 0 to 3 points. A qSOFA&#xD;
      value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these&#xD;
      outcomes being more common in infected patients who may be septic than in those with&#xD;
      uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus&#xD;
      improve the outcome of patients at risk of sepsis or septic shock.&#xD;
&#xD;
      Many patients admitted to the hospital for bacterial sepsis or septic shock are initially&#xD;
      managed in the Emergency Department (ED). This study aims at investigating whether the&#xD;
      routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial&#xD;
      therapy in patients admitted to the ED with suspected or proven bacterial infection,&#xD;
      especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3&#xD;
      definition).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">October 12, 2017</start_date>
  <completion_date type="Actual">June 10, 2018</completion_date>
  <primary_completion_date type="Actual">June 10, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Sequential Assignment</intervention_model>
    <intervention_model_description>Patients will be prospectively included at Emergency Department triage during 2 consecutive 6-month periods (1-month wash-out interlude between the 2 inclusion periods):&#xD;
First inclusion period: usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection.&#xD;
Second inclusion period: usual procedure for patient triage at Emergency Department admission PLUS routine calculation of qSOFA in all patients admitted to the Emergency Department with a suspected or proven bacterial infection. Patients with a qSOFA value ≥2 will be directly and immediately notified to Emergency Department physicians by triage nurses.</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of patients who receive a first dose of antimicrobial agent</measure>
    <time_frame>one hour</time_frame>
    <description>Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within one hour following triage in the emergency department.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who receive a first dose of adequate antimicrobial agent</measure>
    <time_frame>one hour</time_frame>
    <description>Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and microbiologically documented infection who receive a first dose of adequate antimicrobial agent within one hour following triage in the emergency department.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who receive a first dose of antimicrobial agent</measure>
    <time_frame>three hours</time_frame>
    <description>Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within 3 hours following triage in the emergency department.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients who receive a first dose of adequate antimicrobial agent</measure>
    <time_frame>three hours</time_frame>
    <description>Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and a microbiologically documented infection who receive a first dose of adequate antimicrobial agent within 3 hours following triage in the emergency department</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients with a decrease in SOFA score value ≥ 1 point</measure>
    <time_frame>two days</time_frame>
    <description>Proportion of patients with a decrease in SOFA score value ≥ 1 point between triage in the emergency department (Day 0) and Day 2 among those with an initial SOFA score value ≥ 1 point</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Proportion of patients requiring an admission to the Intensive Care Unit</measure>
    <time_frame>two days</time_frame>
    <description>Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>In-hospital mortality at day 7</measure>
    <time_frame>seven days</time_frame>
    <description>Number of patients who died in hospital at day 7</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Overall In-hospital mortality</measure>
    <time_frame>through hospital discharge, up to 3 months</time_frame>
    <description>Number of patients who died in hospital during the hospital stay</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Length of hospital stay</measure>
    <time_frame>throught hospital discharge, up to 3 months</time_frame>
    <description>Number of days in hospital</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">780</enrollment>
  <condition>Bacterial Infection</condition>
  <condition>Intensive Care</condition>
  <arm_group>
    <arm_group_label>systematic calculation of qSOFA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Usual procedure for patient triage AND systematic calculation of qSOFA at Emergency Department triage in patients admitted with a suspected or proven bacterial infection.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>no systematic calculation of qSOFA</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection. No systematic calculation of qSOFA.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>systematic calculation of qSOFA</intervention_name>
    <description>calculation of qSOFA for each patient</description>
    <arm_group_label>systematic calculation of qSOFA</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        • Suspected or proven bacterial infection at emergency department triage&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Imminent death&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Breast-feeding&#xD;
&#xD;
          -  For patients managed by a medicalized pre-hospital emergency team before ED admission&#xD;
             : administration of a first dose of antimicrobial agent before ED admission&#xD;
&#xD;
          -  Lack of coverage by the public health insurance system&#xD;
&#xD;
          -  Patient's refusal for study enrollment&#xD;
&#xD;
          -  Lack of confirmed bacterial infection (i.e., documented either clinically,&#xD;
             microbiologically or by imaging procedures) in patients with a suspected bacterial&#xD;
             infection at emergency departement triage&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>105 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Julien PASSERIEUX, MD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Regional Hospital Center of Orleans</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Regional Hospital center of Orleans</name>
      <address>
        <city>Orléans</city>
        <zip>45067</zip>
        <country>France</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>France</country>
  </location_countries>
  <reference>
    <citation>Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.</citation>
    <PMID>26903338</PMID>
  </reference>
  <verification_date>July 2018</verification_date>
  <study_first_submitted>September 25, 2017</study_first_submitted>
  <study_first_submitted_qc>October 2, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 3, 2017</study_first_posted>
  <last_update_submitted>July 31, 2018</last_update_submitted>
  <last_update_submitted_qc>July 31, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">August 1, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Sepsis</keyword>
  <keyword>Shock, septic</keyword>
  <keyword>Emergency service, hospital</keyword>
  <keyword>Anti-infective agents</keyword>
  <keyword>Outcome assessment</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Bacterial Infections</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/NCT03299894
org study id: CHRO 2017-06
nct id: NCT03299894
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The delayed administration of an adequate antimicrobial therapy is a strong predictor of
      impaired outcome in patients with bacterial sepsis. Therefore, the current Surviving Sepsis
      Campaign guidelines (2016) recommend that administration of intravenous antimicrobials be
      initiated within one hour following the recognition of sepsis or septic shock.

      The quick Sepsis-related Organ Failure Assessment (qSOFA) score is a new bedside tool which
      has been recently proposed by the Third International Sepsis Consensus Definitions Task Force
      (Sepsis-3) to identify patients with suspected infection who are at greater risk for a poor
      outcome outside the Intensive Care Unit (ICU). It uses three criteria, assigning one point
      for low systolic blood pressure (SBP ≤100 mmHg), high respiratory rate (≥22 breaths per min)
      and altered mentation (Glasgow coma scale <15). The score ranges from 0 to 3 points. A qSOFA
      value ≥2 points is associated with a greater risk of death or prolonged ICU stay, these
      outcomes being more common in infected patients who may be septic than in those with
      uncomplicated infection. The definite goal of qSOFA is to hasten the management and thus
      improve the outcome of patients at risk of sepsis or septic shock.

      Many patients admitted to the hospital for bacterial sepsis or septic shock are initially
      managed in the Emergency Department (ED). This study aims at investigating whether the
      routine calculation of qSOFA at patient triage may hasten the initiation of antimicrobial
      therapy in patients admitted to the ED with suspected or proven bacterial infection,
      especially in those with subsequent criteria for sepsis or septic shock (Sepsis-3
      definition).
allocation: Non-Randomized
intervention model: Sequential Assignment
intervention model description: Patients will be prospectively included at Emergency Department triage during 2 consecutive 6-month periods (1-month wash-out interlude between the 2 inclusion periods):
First inclusion period: usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection.
Second inclusion period: usual procedure for patient triage at Emergency Department admission PLUS routine calculation of qSOFA in all patients admitted to the Emergency Department with a suspected or proven bacterial infection. Patients with a qSOFA value ≥2 will be directly and immediately notified to Emergency Department physicians by triage nurses.
primary purpose: Diagnostic
masking: None (Open Label)
measure: Proportion of patients who receive a first dose of antimicrobial agent
time frame: one hour
description: Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within one hour following triage in the emergency department.
measure: Proportion of patients who receive a first dose of adequate antimicrobial agent
time frame: one hour
description: Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and microbiologically documented infection who receive a first dose of adequate antimicrobial agent within one hour following triage in the emergency department.
measure: Proportion of patients who receive a first dose of antimicrobial agent
time frame: three hours
description: Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) who receive a first dose of antimicrobial agent within 3 hours following triage in the emergency department.
measure: Proportion of patients who receive a first dose of adequate antimicrobial agent
time frame: three hours
description: Proportion of patients with criteria for sepsis or septic shock (Sepsis-3 definition) and a microbiologically documented infection who receive a first dose of adequate antimicrobial agent within 3 hours following triage in the emergency department
measure: Proportion of patients with a decrease in SOFA score value ≥ 1 point
time frame: two days
description: Proportion of patients with a decrease in SOFA score value ≥ 1 point between triage in the emergency department (Day 0) and Day 2 among those with an initial SOFA score value ≥ 1 point
measure: Proportion of patients requiring an admission to the Intensive Care Unit
time frame: two days
description: Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2
measure: In-hospital mortality at day 7
time frame: seven days
description: Number of patients who died in hospital at day 7
measure: Overall In-hospital mortality
time frame: through hospital discharge, up to 3 months
description: Number of patients who died in hospital during the hospital stay
measure: Length of hospital stay
time frame: throught hospital discharge, up to 3 months
description: Number of days in hospital
arm group label: systematic calculation of qSOFA
arm group type: Experimental
description: Usual procedure for patient triage AND systematic calculation of qSOFA at Emergency Department triage in patients admitted with a suspected or proven bacterial infection.
arm group label: no systematic calculation of qSOFA
arm group type: No Intervention
description: Usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection. No systematic calculation of qSOFA.
intervention type: Procedure
intervention name: systematic calculation of qSOFA
description: calculation of qSOFA for each patient
arm group label: systematic calculation of qSOFA
criteria: 
gender: All
minimum age: 18 Years
maximum age: 105 Years
healthy volunteers: No
last name: Julien PASSERIEUX, MD
role: Principal Investigator
affiliation: Regional Hospital Center of Orleans
facility: 
country: France
citation: Singer M, Deutschman CS, Seymour CW, Shankar-Hari M, Annane D, Bauer M, Bellomo R, Bernard GR, Chiche JD, Coopersmith CM, Hotchkiss RS, Levy MM, Marshall JC, Martin GS, Opal SM, Rubenfeld GD, van der Poll T, Vincent JL, Angus DC. The Third International Consensus Definitions for Sepsis and Septic Shock (Sepsis-3). JAMA. 2016 Feb 23;315(8):801-10. doi: 10.1001/jama.2016.0287.
PMID: 26903338
responsible party type: Sponsor
mesh term: Infections
mesh term: Bacterial Infections
mesh term: Emergencies