InfectionSepSIGNNCT04261621
Early Identification of SEPsis SIGNs in Emergency Department
An observational study of Infection and Sepsis, run by BioMérieux at 12 sites in 3 countries.
Trial summary
Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- How many people
- 815 participants
- Where
- 12 sitesin 3 countries
- Study dates
- 6 Jul 2020to 2 May 2022
- 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
- All of the following criteria:
- Delay between ED presentation and inclusion must not exceed 12h
- Age 18 years or greater
- Acute infection suspected or confirmed
- That fulfills at least two of the following systemic inflammatory response syndrome (SIRS) criteria:
- Temperature > 38°C (100.4°F) or < 36°C (96.8°F)
Show all 13Show fewer
- Heart rate > 90 bpm
- Respiratory rate > 20 cycles/min or PaCO2 < 32 mmHg
- Leukocyte > 12000/mm3 or < 4000/mm3 or 10% bands
- With a delta SOFA < 2 from baseline
- At Risk for deterioration defined as:
- any patient that the emergency department physician has admitted or intends to admit as an inpatient* to the hospital.
- patients discharged home (outpatient**) who are either i) >65 years old or ii) diagnosed with pneumonia
Who cannot join
- Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this include in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1122-8 of the French Public Health Code.)
- Known pregnancy, in labor or breastfeeding
- Patients with isolated uncomplicated pharyngitis, sinusitis, or otitis media
- Infectious symptoms present for > 5 days prior to presentation
Trial locations and contacts
12 sites in 3 countries.
12 sites in 3 countries
France7 sites
CH Henri Mondor Aurillac
Aurillac, 15000
CHU Grenoble alpes
La Tronche, 38700
CHU Dupuytren
Limoges, 87000
Hopital Edouard Herriot, HCL
Lyon, 69003
CH de Montauban
Montauban, 82000
Hôpital Saint-Antoine AP-HP
Paris, 75012
Hôpital Trousseau CHRU
Tours, 37044
United States4 sites
University of Colorado School of Medicine
Aurora, Colorado, 80045
Beth Israel Deaconess Medical Center
Boston, Massachusetts, 02215
Vanderbilt University Medical Center
Nashville, Tennessee, 37203
University of Washington Medical Center
Seattle, Washington, 98195
About this study
Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.
Read the detailed description
Sepsis is an important health issue with considerable socio-economic consequences. In 2017, the World Health Association made sepsis a global health priority, and has adopted a resolution to improve the prevention, diagnosis, and management of sepsis.
Over the last decade, a decrease in the mortality rate has been observed; in particular thanks to improved management, more appropriate intervention approaches in the Emergency Department (ED) and better recognition of organ failure. This statement is based on qSOFA and SOFA scores from the international Sepsis-3 definition. Sepsis-3 can help front-line clinicians detect severe patients with a higher risk of mortality but does not predict the clinical deterioration especially in patients without initial organ dysfunction. Furthermore, studies still demonstrate that 20% of patients with infection or uncomplicated sepsis experience disease worsening within 72 hours after ED admission.
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.
Unfortunately, as of today, no biological marker has yet been validated to appropriately predict early deterioration in unselected patients admitted to the ED with acute infection, irrespective of their clinical presentation. Physiology of sepsis is complex and some underlying dysfunction could already exist in the early phase of sepsis before patients meet diagnostic criteria. Thus, patients may be clinically asymptomatic at the origin of organ failure. As a result, doubtful patients are often over-hospitalized while they could be treated at home, leading to overcrowding and extra costs for hospitals 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 SepSIGN project is to 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.
- Keywords
- Infection, Sepsis, Worsening, Emergency Department
- Medical subject headings
- Infections, Sepsis, Emergencies
What is being measured
The primary outcome is the main question the study is designed to answer.
number of patients with deterioration within 72-hour period following T0 (enrollment)
clinical deterioration of a patient at any time during the 72-hour period following T0 (enrollment), which is defined as any of the following:
- increase of SOFA score ≥ 2 points
- need of new organ support (respiratory, circulatory, renal)
- death An Endpoint Adjudication Committee (EAC) composed of acute care specialists will apply these criteria. This EAC will also confirm /exclude the presence of infection at T0 (enrollment) based on all information available in eCRF.
Measured: Up to 72 hours after admission
Secondary outcomes (3)
Number of Participants that have been re-admission
Re-admission in hospital any time from T0 to T72h (for patients who have been admitted) OR Admission any time from T0 to T72h (for patients who were discharged from the emergency department)
Measured: Up to 28 days after admission
Number of patients with Early and late mortality
Early and late mortality defined by vital status of patients (alive or dead) at Day 28. This information will be collected on the associated eCRF or obtained using follow up procedures (including telephone call) for the patients discharged.
Measured: Up to 28 days after admission
number of patients with confirmed bacterial and viral infection
the adjudication committee will also confirm site of infection and diagnosis of infection A. Confirmed sites of infections B. Infection status (Infection DEFINITELY present / Infection LIKELY present / Infection LIKELY NOT present / NON INFECTIOUS diagnosis identified) C. Viral versus bacterial infections
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 posted10 Feb 2020
- Study start6 Jul 2020
- Primary completion2 May 2022
- Study completion2 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 815 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioMérieux
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center, Centre d'Investigation Clinique - Limoges
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04261621
- Sponsor's protocol ID
- SepSIGN
- Acronym
- SepSIGN
- Status last verified
- May 2023
- First submitted
- 6 Feb 2020
- Last updated
- 1 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Early Identification of SEPsis SIGNs in Emergency Department
- ClinicalTrials.gov ID
- NCT04261621
- Acronym / sponsor ID
- SepSIGN / SepSIGN
- Keywords
- Infection, Sepsis, Worsening, Emergency Department
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 815 participants (actual)
- Lead sponsor
- BioMérieuxIndustry (pharma, biotech, devices)
- Collaborators
- Vanderbilt University Medical Center, Centre d'Investigation Clinique - Limoges
- Study start
- 6 Jul 2020 (actual)
- Primary completion
- 2 May 2022 (actual)
- Study completion
- 2 May 2022 (actual)
- First posted
- 10 Feb 2020 (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.
Objective of SepSIGN project is to validate biomarkers able to predict the clinical worsening of patients freshly admitted at Emergency Department. Targeted population is adult patients, freshly admitted at ED, with a suspected or confirmed infection.
Detailed description
Sepsis is an important health issue with considerable socio-economic consequences. In 2017, the World Health Association made sepsis a global health priority, and has adopted a resolution to improve the prevention, diagnosis, and management of sepsis.
Over the last decade, a decrease in the mortality rate has been observed; in particular thanks to improved management, more appropriate intervention approaches in the Emergency Department (ED) and better recognition of organ failure. This statement is based on qSOFA and SOFA scores from the international Sepsis-3 definition. Sepsis-3 can help front-line clinicians detect severe patients with a higher risk of mortality but does not predict the clinical deterioration especially in patients without initial organ dysfunction. Furthermore, studies still demonstrate that 20% of patients with infection or uncomplicated sepsis experience disease worsening within 72 hours after ED admission.
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.
Unfortunately, as of today, no biological marker has yet been validated to appropriately predict early deterioration in unselected patients admitted to the ED with acute infection, irrespective of their clinical presentation. Physiology of sepsis is complex and some underlying dysfunction could already exist in the early phase of sepsis before patients meet diagnostic criteria. Thus, patients may be clinically asymptomatic at the origin of organ failure. As a result, doubtful patients are often over-hospitalized while they could be treated at home, leading to overcrowding and extra costs for hospitals 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 SepSIGN project is to 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 (13 listed)
- Delay between ED presentation and inclusion must not exceed 12h
- Age 18 years or greater
- Acute infection suspected or confirmed
- That fulfills at least two of the following systemic inflammatory response syndrome (SIRS) criteria:
- With a delta SOFA < 2 from baseline
Key exclusion criteria (4 listed)
- Unable to obtain a valid and written consent from a patient or their legally authorized representative in accordance with the local regulatory instances (this include in FR: Person not affiliated to a health insurance scheme, or not a beneficiary of such a scheme. Persons who are the subject of a legal protection order. Person with restricted freedom following a legal or administrative decision and a person admitted without their consent pursuant to Articles L.3212-1 and 3213-1, which are not included in Article L.1122-8 of the French Public Health Code.)
- Known pregnancy, in labor or breastfeeding
- Patients with isolated uncomplicated pharyngitis, sinusitis, or otitis media
- Infectious symptoms present for > 5 days prior to presentation
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
number of patients with deterioration within 72-hour period following T0 (enrollment)
Time frame: Up to 72 hours after admission
clinical deterioration of a patient at any time during the 72-hour period following T0 (enrollment), which is defined as any of the following: * increase of SOFA score ≥ 2 points * need of new organ support (respiratory, circulatory, renal) * death An Endpoint Adjudication Committee (EAC) composed of acute care specialists will apply these criteria. This EAC will also confirm /exclude the presence of infection at T0 (enrollment) based on all information available in eCRF.
3 secondary outcomes
Number of Participants that have been re-admission
Time frame: Up to 28 days after admission
Number of patients with Early and late mortality
Time frame: Up to 28 days after admission
number of patients with confirmed bacterial and viral infection
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 1 Jun 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
12 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection and Sepsis, run by BioMérieux at 12 sites in 3 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 13 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 1 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in France, United States, Monaco. 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?
number of patients with deterioration within 72-hour period following T0 (enrollment) (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 1 Jun 2023.