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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT03467672
Other study ID # 6228
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date March 23, 2018
Est. completion date March 2020

Study information

Verified date April 2019
Source University Hospital, Strasbourg, France
Contact Charles-Eric Dr. LAVOIGNET
Phone 03 84 98 33 97
Email Charles-eric.lavoignet@hnfc.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 2000
Est. completion date March 2020
Est. primary completion date March 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Other:
Diagnosis of bacterial infection
use of eosinopenia in the diagnosis of bacterial infection

Locations

Country Name City State
France CH de COLMAR Colmar
France CH de MULHOUSE Mulhouse
France Ch Selestat Sélestat
France Les Hôpitaux Universitaires de Strasbourg Strasbourg
France CH Nord Franche comte Trévenans
France Ch Wissembourg Wissembourg

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Strasbourg, France

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary eosinopenia as a sepsis marker Evaluation of the interest of eosinopenia in the diagnosis of infectious states in emergencies. 102 month