Clinical trial NCT03295045: Evolution of the Profile of Infectious Endocarditis in France in 2008 (EI2008)
Official title: Evolution of the Profile of Infectious Endocarditis in France in 2008
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infective Endocarditis
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Bichat Hospital
name: Hopital Louis Pradel
name: Central Hospital, Nancy, France
name: University Hospital, Montpellier
name: CHU de Reims
name: Rennes University Hospital
name: Hotel Dieu Hospital
name: Henri Mondor University Hospital
First posted: 2017-09-27
Enrollment: 484
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Inpatients with infective endocarditis living in one of the studied regions

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.

Eligibility criteria: 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

Primary outcomes:
measure: Mortality
timeFrame: 1 year
Secondary outcomes:
measure: Frequency of antibiotic resistance by the germs (streptococci and staphylococci)
timeFrame: during the hospitalization, 1 year maximum
Other outcomes:
Locations:
Study officials:
affiliation: Centre Hospitalier Universitaire de Pointe à Pitre
name: Bruno HOEN, MD PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Selton-Suty C, Celard M, Le Moing V, Doco-Lecompte T, Chirouze C, Iung B, Strady C, Revest M, Vandenesch F, Bouvet A, Delahaye F, Alla F, Duval X, Hoen B; AEPEI Study Group. Preeminence of Staphylococcus aureus in infective endocarditis: a 1-year population-based survey. Clin Infect Dis. 2012 May;54(9):1230-9. doi: 10.1093/cid/cis199.
citation: Duval X, Delahaye F, Alla F, Tattevin P, Obadia JF, Le Moing V, Doco-Lecompte T, Celard M, Poyart C, Strady C, Chirouze C, Bes M, Cambau E, Iung B, Selton-Suty C, Hoen B; AEPEI Study Group. Temporal trends in infective endocarditis in the context of prophylaxis guideline modifications: three successive population-based surveys. J Am Coll Cardiol. 2012 May 29;59(22):1968-76. doi: 10.1016/j.jacc.2012.02.029.