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CompletedNCT03295045EI2008Updated Sep 27, 2017

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

An observational study in Infective Endocarditis, sponsored by Centre Hospitalier Universitaire de Besancon. Completed. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2017-09-27.

Sponsored by Centre Hospitalier Universitaire de Besancon · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
484
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infective Endocarditis
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Inpatients with infective endocarditis living in one of the studied regions

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

Exclusion Criteria:

  • Patients not living in one of the studied regions
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
484 participants (actual)
Patient registry
No
05

What researchers measure

Primary outcomes

  1. Mortality

    Vital status

    Time frame: 1 year

Secondary outcomes

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

    antibiotic treatments and outcome

    Time frame: during the hospitalization, 1 year maximum

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Study locations

No study locations are listed for this record.

07

References and documents

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. PubMed 22492317 ↗
  • 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. PubMed 22624837 ↗

Individual participant data

Plan to share: No

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Registry details

Key details

Study ID
NCT03295045
Lead 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
Responsible party
Sponsor
First posted
Sep 27, 2017
Start date
Dec 1, 2007
Primary completion
Dec 31, 2009
Completion
Dec 31, 2010
Last update
Sep 27, 2017

Study contacts

Bruno HOEN, MD PhD
principal investigator · Centre Hospitalier Universitaire de Pointe à Pitre

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.

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