SepsisTRIAGENCT02739152
TRIAGE: TRIage of Sepsis At emerGency dEpartment
An observational study of Sepsis and Severe Sepsis, run by BioMérieux at 14 sites in 2 countries.
Trial summary
Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Sepsis
- How many people
- 602 participants
- Where
- 14 sitesin 2 countries
- Study dates
- Apr 2015to Mar 2018
- 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: Patient freshly admitted to Emergency department
Who may be able to join
- Male or female aged over 18 years
- Patient with a single acute infection site suspected or confirmed by the clinician on clinical or paraclinical manifestations.
- Patient admitted to ED with at least two systemic inflammatory response syndrome (SIRS) criteria
- Patient with symptoms for less than 72 hours upon arrival to the emergency department.
- Patient requiring according to physician judgment of hospitalization for at least 48 hours for his septic episode
- Patient having been informed of the conditions of the study and having signed the informed consent form
Who cannot join
- Patient arrived in an emergency room for over 6 hours.
- Patient with septic shock upon arrival to the ED Patient with acute organ failure on arrival at emergencies other than septic.
- Patient hospitalized in the week before inclusion.
- Patient immunocompromised (HIV, transplanted, patients undergoing chemotherapy, patients receiving treatment> 20 mg / day of prednisolone or equivalent).
- Patient with known pathology among non-infectious pathologies potentially associated with SIRS
- Patient diagnosed with sepsis within 30 days before the date of inclusion.
Show all 11Show fewer
- Patient has already been included in the study.
- Minor Person.
- Person refusing to sign the written consent form.
- Pregnant woman parturient or nursing.
- Patient with no social security insurance, with restricted liberty or under legal protection
Trial locations and contacts
14 sites in 2 countries.
14 sites in 2 countries
France13 sites
Centre Hospitalier Angoulême
Angoulême, 16959
Centre Hospitalier Henri Mondor
Aurillac, 15000
Centre Hospitalier Regional Universitaire de Besançon
Besançon, 25030
Centre Hospitalier Brive La Gaillarde
Brive-la-Gaillarde, 19100
Centre hospitalier universitaire Grenoble Alpes
Grenoble, La Tronche, 38700
Centre Hospitalier Départemental - Hôpital La Roche-sur-Yon
La Roche-sur-Yon, 85000
Centre d'Investigation Clinique (CIC)-CHU Limoges
Limoges, 87042
Centre Hospitalier Universitaire Edouard Herriot
Lyon, 69003
Centre Hospitalier de Montauban
Montauban, 82013
CHU Montpellier
Montpellier, 34295
Assistance publique - Hôpitaux de Paris Hopital de Cochin
Paris, 75014
Centre Hospitalier Régional Universitaire de Tours
Tours, 37044
Centre Hospitalier de Versailles
Versailles
About this study
Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity.
Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities. Also, the severity of the condition may not be apparent at initial contact with ED personnel: patients may arrive at ED with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment Objective of TRIAGE project is to identify and validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department.
Targeted population is adult patients freshly admitted at ED, whom blood samples will serve to validate candidate markers.
- Conditions
- Sepsis, Severe Sepsis
- Keywords
- Sepsis, Severe sepsis, Infections, Worsening
- Medical subject headings
- Sepsis, Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
patient worsening within a time frame of 72h,change, from day of inclusion, in Sequential Organ Failure Assessment score (SOFA) and/or sepsis classification
A biostatistics analysis will be led in two steps. The first analysis or "train set" will be conducted on the first 150 patients enrolled, estimated size to reach statistical performance. The objective is to identify markers associated with clinical worsening of patients and decide on a model by selecting the best combination of markers. In a second time, performance will be confirmed during the "test set". The number of samples to be tested depends on the target performance calculated with the area under the Receiver operating characteristic (ROC) curve (AUC). We decided to aim for an AUC of 0.75, based on the performance described in the literature for some triage score as MEDS (Mortality in Emergency Department Sepsis) or those associated with Lactate concentration used as marker of sepsis deterioration in ED
Measured: Up to 72 hours after admission
Secondary outcomes (1)
patient status at D28 (alive or death)
A biostatistics analysis will be led in two steps. The first analysis or "train set" will be conducted on the first 150 patients enrolled. The objective is to identify markers associated with mortality at day 28. In a second time, the performance will be confirmed during the "test set".
Measured: Up to 28 days after admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2016 (estimated)
- Study startApr 2015
- Primary completionJan 2018
- Study completionMar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 602 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Centre Investigation Clinique, Limoges
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02739152
- Sponsor's protocol ID
- TRIAGE
- Acronym
- TRIAGE
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2016
- Last updated
- 24 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TRIAGE: TRIage of Sepsis At emerGency dEpartment
- ClinicalTrials.gov ID
- NCT02739152
- Acronym / sponsor ID
- TRIAGE / TRIAGE
- Conditions
- Sepsis, Severe Sepsis
- Keywords
- Sepsis, Severe sepsis, Infections, Worsening
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 602 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Collaborators
- Centre Investigation Clinique, Limoges
- Study start
- Apr 2015
- Primary completion
- Jan 2018 (actual)
- Study completion
- Mar 2018 (actual)
- First posted
- 15 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.
Sepsis is a serious systemic disease defined as a combination of Systemic Inflammation Response Syndrome (SIRS) plus a confirmed or suspected infection. Untreated or inadequately treated cases can lead to severe sepsis or septic shock; being characterized by high mortality and morbidity.
Symptoms and signs of sepsis are variable and this makes clinical recognition and assessment very difficult in particular on Emergency Department (ED) patients due to their infectious illness background and the frequent comorbidities. Also, the severity of the condition may not be apparent at initial contact with ED personnel: patients may arrive at ED with mild clinical manifestation and rapidly progress to critical illness, or rather at the opposite others have benign evolution despite a similar symptoms. In these conditions, the main challenge of ED clinicians is differentiating mild infections from life-threatening ones in the heavy workload of ED environment Objective of TRIAGE project is to identify and validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department.
Targeted population is adult patients freshly admitted at ED, whom blood samples will serve to validate candidate markers.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patient freshly admitted to Emergency department
Key inclusion criteria (6 listed)
- Male or female aged over 18 years
- Patient with a single acute infection site suspected or confirmed by the clinician on clinical or paraclinical manifestations.
- Patient admitted to ED with at least two systemic inflammatory response syndrome (SIRS) criteria
- Patient with symptoms for less than 72 hours upon arrival to the emergency department.
- Patient requiring according to physician judgment of hospitalization for at least 48 hours for his septic episode
Key exclusion criteria (11 listed)
- Patient arrived in an emergency room for over 6 hours.
- Patient with septic shock upon arrival to the ED Patient with acute organ failure on arrival at emergencies other than septic.
- Patient hospitalized in the week before inclusion.
- Patient immunocompromised (HIV, transplanted, patients undergoing chemotherapy, patients receiving treatment> 20 mg / day of prednisolone or equivalent).
- Patient with known pathology among non-infectious pathologies potentially associated with SIRS
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
patient worsening within a time frame of 72h,change, from day of inclusion, in Sequential Organ Failure Assessment score (SOFA) and/or sepsis classification
Time frame: Up to 72 hours after admission
A biostatistics analysis will be led in two steps. The first analysis or "train set" will be conducted on the first 150 patients enrolled, estimated size to reach statistical performance. The objective is to identify markers associated with clinical worsening of patients and decide on a model by selecting the best combination of markers. In a second time, performance will be confirmed during the "test set". The number of samples to be tested depends on the target performance calculated with the area under the Receiver operating characteristic (ROC) curve (AUC). We decided to aim for an AUC of 0.75, based on the performance described in the literature for some triage score as MEDS (Mortality in Emergency Department Sepsis) or those associated with Lactate concentration used as marker of sepsis deterioration in ED
1 secondary outcome
patient status at D28 (alive or death)
Time frame: Up to 28 days after admission
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 24 Apr 2018.
- Individual participant dataSharing planned: Yes
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
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CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
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A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
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Not yet recruiting
Double Plasma Separation and Adsorption in Acute-on-Chronic Liver Failure (DPMAS-ACLF Trial)
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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.
The record lists no contact. Use the official record to reach the sponsor.
14 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Severe Sepsis, run by BioMérieux at 14 sites in 2 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 6 inclusion and 11 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 24 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Belgium. 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?
patient worsening within a time frame of 72h,change, from day of inclusion, in Sequential Organ Failure Assessment score (SOFA) and/or sepsis classification (time frame: Up to 72 hours after admission). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Apr 2018.