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

Infective Endocarditis Clinical Trial

— EI2008  

Official title:

Evolution of the Profile of Infectious Endocarditis in France in 2008

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03295045
• Other study ID #: N/2007/50
• Status: Completed
• Phase: N/A
• First received: September 5, 2017
• Last updated: September 26, 2017
• Start date: December 1, 2007
• Est. completion date: December 31, 2010

Study information

• Verified date: September 2017
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 484
• Est. completion date: December 31, 2010
• Est. primary completion date: December 31, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
n/a

Sponsors (9)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Bichat Hospital, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Reims, Henri Mondor University Hospital, Hopital Louis Pradel, Hotel Dieu Hospital, Rennes University Hospital, University Hospital, Montpellier

References & Publications (2)

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 proph — View Citation

Selton-Suty C, Célard 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 populati — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mortality	Vital status	1 year
Secondary	Frequency of antibiotic resistance by the germs (streptococci and staphylococci)	antibiotic treatments and outcome	during the hospitalization, 1 year maximum