Evolution of the Profile of Infectious Endocarditis in France in 2008 (EI2008)

Completed

• Conditions: Infective Endocarditis

• Registration Number: NCT03295045
• Lead Sponsor: Centre Hospitalier Universitaire de Besancon

Brief Summary

Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious (20 % of deaths during hospitalization) disease . Its epidemiological profile was considerably modified these last years.New predisposing factors appeared, due to increasing number of patients wearing valvular prosthetics. The purpose of this study is to realize in 2008 a new observational study on populational basis to describe and analyze the evolution of the epidemiology of IE in France, compared to previous studies conducted in 1991 and 1999.

Detailed Description

It is a prospective observational study based on a population of 25 million inhabitants. The cases are recruited over a one year period, from January 1st till December 31st, 2008, in six regions of France (Rhône-Alpes, Paris et Petite Couronne, Lorraine, Franche-Comté, Marne, Languedoc-Roussillon) and in the department of Ille-et-Vilaine. The IE cases are declared by clinicians taking care of the patients, microbiologists and cardiac ultrasonographists.

Study Timeline

• Study Start: 2007-12-01
• Primary Completion: 2009-12-31
• Study Completion: 2010-12-31
• Status Verified: 2017-09
• Study First Submitted: 2017-09-05
• Study First Submitted QC: 2017-09-26
• Last Update Submitted: 2017-09-26
• Study First Posted: 2017-09-27
• Last Update Posted: 2017-09-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 484

Inclusion Criteria

• Major Patient

• Supported in one of the participating centers

• The application of diagnostic classification criteria of Duke modified by Li is carried out after collection of all the data at the output of the patient. Will be included in the observatory that patients meeting criteria for definite or possible endocarditis.

  • Affiliated with the French social security regime

Exclusion Criteria

• Patients not living in one of the studied regions

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mortality	1 year	Vital status

Secondary Outcome Measures

Name	Time	Method
Frequency of antibiotic resistance by the germs (streptococci and staphylococci)	during the hospitalization, 1 year maximum	antibiotic treatments and outcome