Hygiene and Bucco-dental Status of Patients With Oral Streptococcal Endocarditis

Infective Endocarditis Clinical Trial

— EI-DENTS  

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03612245
• Other study ID #: HC/2010/26
• Status: Completed
• Start date: May 1, 2008
• Est. completion date: July 1, 2012

Study information

• Verified date: July 2018
• Source: Centre Hospitalier Universitaire de Besancon
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

It is a case-control observational study. The IE cases are recruited in hospitals participating to the french prospective observational "EI2008" cohort.

Cases are IE with oral streptococci whereas controls are IE with microorganisms not of oral origin.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 403
• Est. completion date: July 1, 2012
• Est. primary completion date: July 1, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Major patient

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

Exclusion Criteria:

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
n/a

Sponsors (6)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Besancon	Bichat Hospital, Central Hospital, Nancy, France, Centre Hospitalier Universitaire de Reims, Pitié-Salpêtrière Hospital, Rennes University Hospital

References & 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 Prévention de l'Endocardite Infectieuse (AEPEI) Study Group . Oral Streptococcal Endocardi — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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