SepSIGN: Early Identification of SEPsis SIGNs in Emergency Department

Sponsor

BioMérieux (Industry)

Overall Status

Recruiting

CT.gov ID

NCT04261621

Collaborator

Vanderbilt University Medical Center (Other), Centre d'Investigation Clinique - Limoges (Other)

1,850

Enrollment

Locations

22.8

Anticipated Duration (Months)

154.2

Patients Per Site

6.8

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Infection Sepsis

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

Study Type:

Observational

Anticipated Enrollment :

1850 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

Official Title:

Early Identification of SEPsis SIGNs in Emergency Department

Actual Study Start Date :

Jul 6, 2020

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Jun 1, 2022

Outcome Measures

Primary Outcome Measures

number of patients with deterioration within 72-hour period following T0 (enrollment) [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.

Secondary Outcome Measures

Number of Participants that have been re-admission [Up to 28 days after 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)
Number of patients with Early and late mortality [Up to 28 days after admission]
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.
number of patients with confirmed bacterial and viral infection [Up to 28 days after admission]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

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)
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

Exclusion Criteria:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Colorado School of Medicine	Aurora	Colorado	United States	80045
2	Beth Israel Deaconess Medical Center	Boston	Massachusetts	United States	02215
3	Vanderbilt University Medical Center	Nashville	Tennessee	United States	37203
4	University of Washington Medical Center	Seattle	Washington	United States	98195
5	CH Henri Mondor Aurillac	Aurillac		France	15000
6	CHU Grenoble alpes	La Tronche		France	38700
7	CHU Dupuytren	Limoges		France	87000
8	Hopital Edouard Herriot, HCL	Lyon		France	69003
9	CH de Montauban	Montauban		France	82000
10	Hôpital Saint-Antoine AP-HP	Paris		France	75012
11	Hôpital Trousseau CHRU	Tours		France	37044
12	Centre Hospitalier Princesse Grace	Monaco		Monaco	98000