NCT03612245

Brief Summary

Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious disease (20 % of deaths during hospitalization and 40 % after 5 years). The development of an IE results from the meeting between a bacteremia and a pre-existent heart disorder, most of the time valvular, allowing the transplant of the circulating bacteria and their multiplication in the endocardium. Recommendations of prophylactic antibiotic treatment have been established since 1954 for some medical, particularly dental procedures, at the origin of bacteremia. But this policy has recently been questioned because its efficacy has not been demonstrated. The purpose of this study is identify the situations with risk, by comparing the oral health status and the hygiene of patients having an IE with oral streptococci to those in patients having an IE with microorganisms not of oral origin.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
403

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started May 2008

Longer than P75 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

May 1, 2008

Completed
4.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2012

Completed
6.1 years until next milestone

First Submitted

Initial submission to the registry

July 26, 2018

Completed
7 days until next milestone

First Posted

Study publicly available on registry

August 2, 2018

Completed
Last Updated

August 2, 2018

Status Verified

July 1, 2018

Enrollment Period

4.2 years

First QC Date

July 26, 2018

Last Update Submit

July 26, 2018

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

  • Oral health status

    Dental and periodontal evaluation by a dental surgeon or a stomatologist, according to a protocol of standardized examination

    During the IE event

Eligibility Criteria

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

Patients with definite IE treated in one of the participating hospitals.

You may qualify if:

  • Major patient
  • Definite IE caused by oral streptococci (case) or by non-oral pathogens (control)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Duval X, Millot S, Chirouze C, Selton-Suty C, Moby V, Tattevin P, Strady C, Euvrard E, Agrinier N, Thomas D, Hoen B, Alla F; EI-dents Association pour l'Etude et la Prevention de l'Endocardite Infectieuse (AEPEI) Study Group. Oral Streptococcal Endocarditis, Oral Hygiene Habits, and Recent Dental Procedures: A Case-Control Study. Clin Infect Dis. 2017 Jun 15;64(12):1678-1685. doi: 10.1093/cid/cix237.

    PMID: 28369398RESULT

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Design

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

Study Record Dates

First Submitted

July 26, 2018

First Posted

August 2, 2018

Study Start

May 1, 2008

Primary Completion

July 1, 2012

Study Completion

July 1, 2012

Last Updated

August 2, 2018

Record last verified: 2018-07

Data Sharing

IPD Sharing
Will not share