Early Identification of SEPsis SIGNs in Emergency Department

NCT04261621 | Completed DMC

• 1 other identifier: SepSIGN
• Study Type: observational
• Target: 815
• Locations: 3 countries
• Sites: 12

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.

Conditions

Infection; Sepsis

Keywords

Infection; Sepsis; Worsening; Emergency Department

Outcome Measures

Primary Outcomes (1)

• 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.

  Up to 72 hours after admission

Secondary Outcomes (3)

• Number of Participants that have been re-admission

  Up to 28 days after admission

• Number of patients with Early and late mortality

  Up to 28 days after admission

• number of patients with confirmed bacterial and viral infection

  Up to 28 days after admission

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient freshly admitted to Emergency department

You may qualify if:

• All of the following criteria:
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BioMérieux: lead
• Vanderbilt University Medical Center: collaborator
• Centre d'Investigation Clinique - Limoges: collaborator

Study Sites (12)

University of Colorado School of Medicine

Aurora, Colorado, 80045, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37203, United States

Location

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

CH Henri Mondor Aurillac

Aurillac, 15000, France

Location

CHU Grenoble alpes

La Tronche, 38700, France

Location

CHU Dupuytren

Limoges, 87000, France

Location

Hopital Edouard Herriot, HCL

Lyon, 69003, France

Location

CH de Montauban

Montauban, 82000, France

Location

Hôpital Saint-Antoine AP-HP

Paris, 75012, France

Location

Hôpital Trousseau CHRU

Tours, 37044, France

Location

Centre Hospitalier Princesse Grace

Monaco, 98000, Monaco

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Four types of samples are taken for the study per patient at T0: * Up to 3ml of urine * 2.5 mL of whole blood collected in a PAXgene tube * 7 mL collected in a dry tube for serum biobank * 7 mL collected in a lithium heparin tube for plasma biobank

MeSH Terms

Conditions

Infections; Sepsis; Emergencies

Condition Hierarchy (Ancestors)

Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Disease Attributes

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2020
• First Posted: February 10, 2020
• Study Start: July 6, 2020
• Primary Completion: May 2, 2022
• Study Completion: May 2, 2022
• Last Updated: June 1, 2023

Record last verified: 2023-05

Locations

US (4); FR (7); MO (1)