SepsisSCREENNCT02738164
SEPSIS 3 Critera for Risk Stratification in Emergency Patients
An observational study of Sepsis and Emergency, run by Societe Française de Medecine d'urgence at 27 sites in 4 countries.
Trial summary
Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner. Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 879 participants
- Where
- 27 sitesin 4 countries
- Study dates
- May 2016to Jul 2016
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Emergency patients with infection
Who may be able to join
- Adult that present to the emergency department
- Diagnosis of infection by the treating emergency physician
Who cannot join
- Refuse to participate
- pregnancy
- prisoner
- Low acuity infection (localised, not requiring general treatment, without any abnormal vital parameters)
Trial locations and contacts
27 sites in 4 countries.
27 sites in 4 countries
France24 sites
CHU Angers
Angers
CHIPO
Beaumont S Oise
Avicenne
Bobigny
Saint Camille
Bry-sur-Marne
Dijon
Dijon
Grenoble
Grenoble
Longjumeau
Longjumeau
Lyon
Lyon
Princess Grace
Monaco
Nancy
Nancy
Nice
Nice
Ambroise Paré
Paris
Bichat
Paris
Cochin
Paris
HEGP
Paris
Lariboisière
Paris
Pitie-salpetriere
Paris
Saint-Antoine
Paris
St Louis
Paris
Tenon
Paris
Strasbourg
Strasbourg
Toulouse
Toulouse
Tours
Tours
Vienne
Vienne
About this study
Official title: Validation of the SEPSIS-3 Criterion for Sepsis and Septic Shock in the Emergency Department
Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner.
Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection
- Medical subject headings
- Sepsis, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
In hospital mortality
Measured: 30 days
Secondary outcomes (3)
admission in ICU
Measured: 30 days
length of ICU stay more than 72 hours
Measured: 30 days
Length of hospital stay
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2016 (estimated)
- Study startMay 2016
- Primary completionJul 2016
- Study completionJul 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SepsisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 879 participants (actual)
Sponsor and investigators
- Lead sponsor
- Societe Française de Medecine d'urgence
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yonathan Freund, MD, PhD, Principal investigator, SFMU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02738164
- Sponsor's protocol ID
- SCREEN_SFMU
- Acronym
- SCREEN
- Status last verified
- Jul 2016
- First submitted
- 2 Apr 2016
- Last updated
- 19 Jul 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Publications
Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.
PubMed 28114554
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of the SEPSIS-3 Criterion for Sepsis and Septic Shock in the Emergency Department
- ClinicalTrials.gov ID
- NCT02738164
- Acronym / sponsor ID
- SCREEN / SCREEN_SFMU
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 879 participants (actual)
- Lead sponsor
- Societe Française de Medecine d'urgenceUniversity, hospital or other
- Study start
- May 2016
- Primary completion
- Jul 2016 (actual)
- Study completion
- Jul 2016 (actual)
- First posted
- 14 Apr 2016 (estimated)
- 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.
Investigators aim to evaluate the SEPSIS 3 criterion for "sepsis" and "septic shock" in a prospective manner.
Investigators will evaluate qSOFA performances and other SEPSIS 3 criterion in a population of emergency patients with infection
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Emergency patients with infection
Key inclusion criteria (2 listed)
- Adult that present to the emergency department
- Diagnosis of infection by the treating emergency physician
Key exclusion criteria (4 listed)
- Refuse to participate
- pregnancy
- prisoner
- Low acuity infection (localised, not requiring general treatment, without any abnormal vital parameters)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
In hospital mortality
Time frame: 30 days
3 secondary outcomes
admission in ICU
Time frame: 30 days
length of ICU stay more than 72 hours
Time frame: 30 days
Length of hospital stay
Time frame: 30 days
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 19 Jul 2016.
- Derived from this study: PubMed 28114554Freund Y, Lemachatti N, Krastinova E, Van Laer M, Claessens YE, Avondo A, Occelli C, Feral-Pierssens AL, Truchot J, Ortega M, Carneiro B, Pernet J, Claret PG, Dami F, Bloom B, Riou B, Beaune S; French Society of Emergency Medicine Collaborators Group. Prognostic Accuracy of Sepsis-3 Criteria for In-Hospital Mortality Among Patients With Suspected Infection Presenting to the Emergency Department. JAMA. 2017 Jan 17;317(3):301-308. doi: 10.1001/jama.2016.20329.
- Individual participant dataSharing planned: Undecided
Related trials for Sepsis
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
Acute-on-Chronic Liver Failure (ACLF)
Active, not recruitingPhase 4
Thymosin Alpha 1 and IgM Levels in Sepsis
Sepsis, Septic Shock
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.
Yonathan Freund, MD, PhD principal investigator
SFMU
27 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Emergency, run by Societe Française de Medecine d'urgence at 27 sites in 4 countries.
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 2 inclusion and 4 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 19 Jul 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 27 sites in France, Belgium, Spain, Switzerland. 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?
In hospital mortality (time frame: 30 days). 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 NCT02738164, which also lists 1 linked publication.
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 19 Jul 2016.