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Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department (qSOFAST)

Primary Purpose

Bacterial Infection, Intensive Care

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
systematic calculation of qSOFA
Sponsored by
Centre Hospitalier Régional d'Orléans
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Bacterial Infection focused on measuring Sepsis, Shock, septic, Emergency service, hospital, Anti-infective agents, Outcome assessment

Eligibility Criteria

18 Years - 105 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Suspected or proven bacterial infection at emergency department triage

Exclusion Criteria:

  • Imminent death
  • Pregnancy
  • Breast-feeding
  • For patients managed by a medicalized pre-hospital emergency team before ED admission : administration of a first dose of antimicrobial agent before ED admission
  • Lack of coverage by the public health insurance system
  • Patient's refusal for study enrollment
  • Lack of confirmed bacterial infection (i.e., documented either clinically, microbiologically or by imaging procedures) in patients with a suspected bacterial infection at emergency departement triage

Sites / Locations

  • Regional Hospital center of Orleans

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

systematic calculation of qSOFA

no systematic calculation of qSOFA

Arm 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.

Usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection. No systematic calculation of qSOFA.

Outcomes

Primary Outcome Measures

Proportion of patients who receive a first dose of antimicrobial agent
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.

Secondary Outcome Measures

Proportion of patients who receive a first dose of adequate antimicrobial agent
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.
Proportion of patients who receive a first dose of antimicrobial agent
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.
Proportion of patients who receive a first dose of adequate antimicrobial agent
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
Proportion of patients with a decrease in SOFA score value ≥ 1 point
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
Proportion of patients requiring an admission to the Intensive Care Unit
Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2
In-hospital mortality at day 7
Number of patients who died in hospital at day 7
Overall In-hospital mortality
Number of patients who died in hospital during the hospital stay
Length of hospital stay
Number of days in hospital

Full Information

First Posted
September 25, 2017
Last Updated
July 31, 2018
Sponsor
Centre Hospitalier Régional d'Orléans
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1. Study Identification

Unique Protocol Identification Number
NCT03299894
Brief Title
Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department
Acronym
qSOFAST
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
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Completed
Study Start Date
October 12, 2017 (Actual)
Primary Completion Date
June 10, 2018 (Actual)
Study Completion Date
June 10, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Régional d'Orléans

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Infection, Intensive Care
Keywords
Sepsis, Shock, septic, Emergency service, hospital, Anti-infective agents, Outcome assessment

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
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.
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
780 (Actual)

8. Arms, Groups, and Interventions

Arm Title
systematic calculation of qSOFA
Arm Type
Experimental
Arm 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 Title
no systematic calculation of qSOFA
Arm Type
No Intervention
Arm 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(s)
systematic calculation of qSOFA
Intervention Description
calculation of qSOFA for each patient
Primary Outcome Measure Information:
Title
Proportion of patients who receive a first dose of antimicrobial agent
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.
Time Frame
one hour
Secondary Outcome Measure Information:
Title
Proportion of patients who receive a first dose of adequate antimicrobial agent
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.
Time Frame
one hour
Title
Proportion of patients who receive a first dose of antimicrobial agent
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.
Time Frame
three hours
Title
Proportion of patients who receive a first dose of adequate antimicrobial agent
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
Time Frame
three hours
Title
Proportion of patients with a decrease in SOFA score value ≥ 1 point
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
Time Frame
two days
Title
Proportion of patients requiring an admission to the Intensive Care Unit
Description
Proportion of patients requiring an admission to the Intensive Care Unit between triage in the emergency department (Day 0) and Day 2
Time Frame
two days
Title
In-hospital mortality at day 7
Description
Number of patients who died in hospital at day 7
Time Frame
seven days
Title
Overall In-hospital mortality
Description
Number of patients who died in hospital during the hospital stay
Time Frame
through hospital discharge, up to 3 months
Title
Length of hospital stay
Description
Number of days in hospital
Time Frame
throught hospital discharge, up to 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
105 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Suspected or proven bacterial infection at emergency department triage Exclusion Criteria: Imminent death Pregnancy Breast-feeding For patients managed by a medicalized pre-hospital emergency team before ED admission : administration of a first dose of antimicrobial agent before ED admission Lack of coverage by the public health insurance system Patient's refusal for study enrollment Lack of confirmed bacterial infection (i.e., documented either clinically, microbiologically or by imaging procedures) in patients with a suspected bacterial infection at emergency departement triage
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Julien PASSERIEUX, MD
Organizational Affiliation
Regional Hospital Center of Orleans
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Hospital center of Orleans
City
Orléans
ZIP/Postal Code
45067
Country
France

12. IPD Sharing Statement

Citations:
PubMed Identifier
26903338
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.
Results Reference
background
PubMed Identifier
31103379
Citation
Petit J, Passerieux J, Maitre O, Guerin C, Rozelle C, Cordeau O, Cassonnet A, Malet A, Boulain T, Barbier F; qSOFAST study group. Impact of a qSOFA-based triage procedure on antibiotic timing in ED patients with sepsis: A prospective interventional study. Am J Emerg Med. 2020 Mar;38(3):477-484. doi: 10.1016/j.ajem.2019.05.022. Epub 2019 May 10.
Results Reference
derived

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Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department

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