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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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
CHU de Reims
Rennes University Hospital
Hotel Dieu Hospital
Henri Mondor University Hospital
Information provided by (Responsible Party):
Centre Hospitalier Universitaire de Besancon

Tracking Information
First Submitted Date September 5, 2017
First Posted Date September 27, 2017
Last Update Posted Date September 27, 2017
Actual Study Start Date December 1, 2007
Actual Primary Completion Date December 31, 2009   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 26, 2017)
Mortality [ Time Frame: 1 year ]
Vital status
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: September 26, 2017)
Frequency of antibiotic resistance by the germs (streptococci and staphylococci) [ Time Frame: during the hospitalization, 1 year maximum ]
antibiotic treatments and outcome
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Inpatients with infective endocarditis living in one of the studied regions
Condition Infective Endocarditis
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: September 26, 2017)
484
Original Actual Enrollment Same as current
Actual Study Completion Date December 31, 2010
Actual Primary Completion Date December 31, 2009   (Final data collection date for primary outcome measure)
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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number NCT03295045
Other Study ID Numbers N/2007/50
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Centre Hospitalier Universitaire de Besancon
Study Sponsor Centre Hospitalier Universitaire de Besancon
Collaborators
  • Bichat Hospital
  • Hopital Louis Pradel
  • Central Hospital, Nancy, France
  • University Hospital, Montpellier
  • CHU 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
PRS Account Centre Hospitalier Universitaire de Besancon
Verification Date September 2017