NCT03295045

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
484

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2007

Typical duration for all trials

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2009

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2010

Completed
6.7 years until next milestone

First Submitted

Initial submission to the registry

September 5, 2017

Completed
22 days until next milestone

First Posted

Study publicly available on registry

September 27, 2017

Completed
Last Updated

September 27, 2017

Status Verified

September 1, 2017

Enrollment Period

2.1 years

First QC Date

September 5, 2017

Last Update Submit

September 26, 2017

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Vital status

    1 year

Secondary Outcomes (1)

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

    during the hospitalization, 1 year maximum

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Inpatients with infective endocarditis living in one of the studied regions

You may qualify if:

  • 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

You may not qualify if:

  • Patients not living in one of the studied regions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Bruno HOEN, MD PhD

    Centre Hospitalier Universitaire de Pointe à Pitre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 5, 2017

First Posted

September 27, 2017

Study Start

December 1, 2007

Primary Completion

December 31, 2009

Study Completion

December 31, 2010

Last Updated

September 27, 2017

Record last verified: 2017-09

Data Sharing

IPD Sharing
Will not share