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Completed

NCT Number: NCT03295045

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

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.

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Key information

Conditions

Infective Endocarditis Cardiovascular Diseases Endocarditis Heart Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Mortality

    Time frame: 1 year

    Vital status

Secondary outcomes

  1. Frequency of antibiotic resistance by the germs (streptococci and staphylococci)

    Time frame: during the hospitalization, 1 year maximum

    antibiotic treatments and outcome

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Besancon

Other

Collaborators

  • Bichat Hospital
  • CHU de Reims
  • Central Hospital, Nancy, France
  • Henri Mondor University Hospital
  • Hopital Louis Pradel
  • Hotel Dieu Hospital
  • Rennes University Hospital
  • University Hospital, Montpellier

Registry information

Official study title

Evolution of the Profile of Infectious Endocarditis in France in 2008

Acronym: EI2008

Important dates

Study start
2007
Primary completion
2009
Study completion
2010
First posted
Sep 27, 2017
Registry last updated
Sep 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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