Bacterial InfectionqSOFASTNCT03299894
Impact of qSOFA Calculation on the Timing of Antimicrobial Therapy in the Emergency Department
A study testing systematic calculation of qSOFA in people with Bacterial Infection and Intensive Care, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 105 years
- Conditions the study is for
- Bacterial Infection, Intensive Care
- What is being tested?
- systematic calculation of qSOFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 780 participants
- Where
- 1 siteFrance
- Study dates
- 12 Oct 2017to 10 Jun 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 105 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Suspected or proven bacterial infection at emergency department triage
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
- Conditions
- Bacterial Infection, Intensive Care
- Being tested
- systematic calculation of qSOFA
- Keywords
- Sepsis, Shock, septic, Emergency service, hospital, Anti-infective agents, Outcome assessment
- Medical subject headings
- Bacterial Infections, Sepsis, Shock, Septic, Emergencies
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
systematic calculation of qSOFAProcedure or surgery
calculation of qSOFA for each patient
| Study group | Role | What they receive |
|---|---|---|
| systematic calculation of qSOFA | Experimental | Usual procedure for patient triage AND systematic calculation of qSOFA at Emergency Department triage in patients admitted with a suspected or proven bacterial infection. Receives: Procedure: systematic calculation of qSOFA |
| no systematic calculation of qSOFA | No intervention | Usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection. No systematic calculation of qSOFA. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: one hour
Secondary outcomes (8)
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.
Measured: one hour
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.
Measured: three hours
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
Measured: three hours
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
Measured: two days
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
Measured: two days
In-hospital mortality at day 7
Number of patients who died in hospital at day 7
Measured: seven days
Overall In-hospital mortality
Number of patients who died in hospital during the hospital stay
Measured: through hospital discharge, up to 3 months
Length of hospital stay
Number of days in hospital
Measured: throught hospital discharge, up to 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Oct 2017
- Study start12 Oct 2017
- Primary completion10 Jun 2018
- Study completion10 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- 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)
- Enrolment
- 780 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Régional d'Orléans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Julien PASSERIEUX, MD, Principal investigator, Regional Hospital Center of Orleans
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03299894
- Sponsor's protocol ID
- CHRO 2017-06
- Acronym
- qSOFAST
- Status last verified
- Jul 2018
- First submitted
- 25 Sep 2017
- Last updated
- 1 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 26903338Petit 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.
PubMed 31103379
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03299894
- Acronym / sponsor ID
- qSOFAST / CHRO 2017-06
- Conditions
- Bacterial Infection, Intensive Care
- Keywords
- Sepsis, Shock, septic, Emergency service, hospital, Anti-infective agents, Outcome assessment
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 780 participants (actual)
- Lead sponsor
- Centre Hospitalier Régional d'OrléansUniversity, hospital or other
- Study start
- 12 Oct 2017 (actual)
- Primary completion
- 10 Jun 2018 (actual)
- Study completion
- 10 Jun 2018 (actual)
- First posted
- 3 Oct 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| systematic calculation of qSOFA | Experimental | Procedure: systematic calculation of qSOFAUsual procedure for patient triage AND systematic calculation of qSOFA at Emergency Department triage in patients admitted with a suspected or proven bacterial infection. |
| no systematic calculation of qSOFA | No intervention | –Usual procedures for patient triage at Emergency Department admission and management of suspected or proven bacterial infection. No systematic calculation of qSOFA. |
Who may qualify
- Ages
- 18 to 105 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Suspected or proven bacterial infection at emergency department triage
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| systematic calculation of qSOFAcalculation of qSOFA for each patient | Procedure or surgery | systematic calculation of qSOFA |
Primary outcome
Proportion of patients who receive a first dose of antimicrobial agent
Time frame: one hour
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.
8 secondary outcomes
Proportion of patients who receive a first dose of adequate antimicrobial agent
Time frame: one hour
Proportion of patients who receive a first dose of antimicrobial agent
Time frame: three hours
Proportion of patients who receive a first dose of adequate antimicrobial agent
Time frame: three hours
Proportion of patients with a decrease in SOFA score value ≥ 1 point
Time frame: two days
Proportion of patients requiring an admission to the Intensive Care Unit
Time frame: two days
In-hospital mortality at day 7
Time frame: seven days
Overall In-hospital mortality
Time frame: through hospital discharge, up to 3 months
Length of hospital stay
Time frame: throught hospital discharge, up to 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2018.
- Background: PubMed 26903338Singer 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.
- Derived from this study: PubMed 31103379Petit 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Julien PASSERIEUX, MD principal investigator
Regional Hospital Center of Orleans
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing systematic calculation of qSOFA in people with Bacterial Infection and Intensive Care, run by Centre Hospitalier Régional d'Orléans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who receive a first dose of antimicrobial agent (time frame: one hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03299894, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2018.