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

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ClinicalTrials.gov Identifier: NCT03295045
Recruitment Status : Completed
First Posted : September 27, 2017
Last Update Posted : September 27, 2017
Sponsor:
Collaborators:
Bichat Hospital
Hopital Louis Pradel
Central Hospital, Nancy, France
University Hospital, Montpellier
Centre Hospitalier Universitaire de Reims
Rennes University Hospital
Hotel Dieu Hospital
Henri Mondor University Hospital
Information provided by (Responsible Party):
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.

Condition or disease
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
Actual Enrollment : 484 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evolution of the Profile of Infectious Endocarditis in France in 2008
Actual Study Start Date : December 1, 2007
Actual Primary Completion Date : December 31, 2009
Actual Study Completion Date : December 31, 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis




Primary Outcome Measures :
  1. Mortality [ Time Frame: 1 year ]
    Vital status


Secondary Outcome Measures :
  1. Frequency of antibiotic resistance by the germs (streptococci and staphylococci) [ Time Frame: during the hospitalization, 1 year maximum ]
    antibiotic treatments and outcome



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Inpatients with infective endocarditis living in one of the studied regions
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03295045


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

Publications of Results:
Responsible Party: Centre Hospitalier Universitaire de Besancon
ClinicalTrials.gov Identifier: NCT03295045     History of Changes
Other Study ID Numbers: N/2007/50
First Posted: September 27, 2017    Key Record Dates
Last Update Posted: September 27, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Endocarditis
Endocarditis, Bacterial
Endocarditis, Subacute Bacterial
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection
Streptococcal Infections
Gram-Positive Bacterial Infections