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

Evolution of the Profile of Infectious Endocarditis in France in 2008

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.

Study Overview

• Status: Completed
• Conditions: Infective Endocarditis

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 Type: Observational
• Enrollment (Actual): 484

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Inpatients with infective endocarditis living in one of the studied regions

Description

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 Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mortality	Vital status	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Frequency of antibiotic resistance by the germs (streptococci and staphylococci)	antibiotic treatments and outcome	during the hospitalization, 1 year maximum

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Besancon
• Collaborators: CHU de Reims; University Hospital, Montpellier; Central Hospital, Nancy, France; Rennes University Hospital; Henri Mondor University Hospital; Bichat Hospital; Hotel Dieu Hospital; Hopital Louis Pradel
• Investigators: Principal Investigator: Bruno HOEN, MD PhD, Centre Hospitalier Universitaire de Pointe à Pitre

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2007
• Primary Completion (Actual): December 31, 2009
• Study Completion (Actual): December 31, 2010

Study Registration Dates

• First Submitted: September 5, 2017
• First Submitted That Met QC Criteria: September 26, 2017
• First Posted (Actual): September 27, 2017

Study Record Updates

• Last Update Posted (Actual): September 27, 2017
• Last Update Submitted That Met QC Criteria: September 26, 2017
• Last Verified: September 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Heart Diseases; Cardiovascular Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Streptococcal Infections; Gram-Positive Bacterial Infections; Cardiovascular Infections; Endocarditis, Bacterial; Endocarditis; Endocarditis, Subacute Bacterial
• Other Study ID Numbers: N/2007/50

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No