Interest of Eosinopia in the Diagnosis of Infection in the Emergency Department (SEPSISEO)

April 29, 2019 updated by: University Hospital, Strasbourg, France

Several studies have described the interest of eosinopenia as a marker of infection in internal medicine or in intensive care units. Eosinopenia is an inexpensive and easily accessible biological marker of sepsis. Retrospective work in the adult emergency departments of Strasbourg University Hospitals has shown the good specificity of this biological sign for the diagnosis of infection. Our work aims to confirm the results by a more meaningful study.

Main objective: Evaluation of the interest of eosinopenia in the diagnosis of bacterial infection in ED.

Methodology: inclusion of all patients with criteria for bacterial infection in ED, inclusion of an equivalent number of uninfected control patients.

Duration : 12 months Multicentric prospective study 6 centers : Strasbourg, Hôpital Nord Franche comté, Sélestat, Wissembourg, Colmar, Mulhouse

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Any adult emergency counseling subjects who benefit from the routine practice of NFS for any indication.

Description

Inclusion Criteria:

  • major patient
  • patient suspected of infection and benefiting from the routine practice of NFS, whatever the indication during his / her visit to the emergency room.
  • patient with or without criteria for bacterial infection
  • patient affiliated to a social security scheme
  • patient (or legal representative) who has agreed to participate in the study

Exclusion Criteria:

  • anti tumor chemotherapy
  • immunosuppressive treatment
  • corticotherapy
  • antibiotherapy in progress
  • malignant hemopathy
  • evolutionary cancer
  • refusal to participate in the study
  • subjects under safeguard of justice
  • subject under guardianship or curatorship

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Control group
Other: Diagnosis of bacterial infection
use of eosinopenia in the diagnosis of bacterial infection
Infected patients
Other: Diagnosis of bacterial infection
use of eosinopenia in the diagnosis of bacterial infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
eosinopenia as a sepsis marker
Time Frame: 102 month
Evaluation of the interest of eosinopenia in the diagnosis of infectious states in emergencies.
102 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Strasbourg, France

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 23, 2018

Primary Completion (Anticipated)

March 1, 2020

Study Completion (Anticipated)

March 1, 2020

Study Registration Dates

First Submitted

February 12, 2018

First Submitted That Met QC Criteria

March 15, 2018

First Posted (Actual)

March 16, 2018

Study Record Updates

Last Update Posted (Actual)

May 1, 2019

Last Update Submitted That Met QC Criteria

April 29, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 6228

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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