Infective EndocarditisEI-DENTSNCT03612245
Hygiene and Bucco-dental Status of Patients With Oral Streptococcal Endocarditis
An observational study of Infective Endocarditis, run by Centre Hospitalier Universitaire de Besancon.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- How many people
- 403 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2008to 1 Jul 2012
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with definite IE treated in one of the participating hospitals.
Who may be able to join
- Major patient
- Definite IE caused by oral streptococci (case) or by non-oral pathogens (control)
Who cannot join
- -
About this study
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.
Read the detailed 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.
- Conditions
- Infective Endocarditis
- Medical subject headings
- Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Oral health status
Dental and periodontal evaluation by a dental surgeon or a stomatologist, according to a protocol of standardized examination
Measured: During the IE event
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start1 May 2008
- Primary completion1 Jul 2012
- Study completion1 Jul 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Infective EndocarditisStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire de BesanconThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 403 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- Collaborators
- Bichat Hospital, Central Hospital, Nancy, France, CHU de Reims, Pitié-Salpêtrière Hospital, Rennes University Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03612245
- Sponsor's protocol ID
- HC/2010/26
- Acronym
- EI-DENTS
- Status last verified
- Jul 2018
- First submitted
- 26 Jul 2018
- Last updated
- 2 Aug 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 28369398
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hygiene and Bucco-dental Status of Patients With Oral Streptococcal Endocarditis
- ClinicalTrials.gov ID
- NCT03612245
- Acronym / sponsor ID
- EI-DENTS / HC/2010/26
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 403 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- Collaborators
- Bichat Hospital, Central Hospital, Nancy, France, CHU de Reims, Pitié-Salpêtrière Hospital, Rennes University Hospital
- Study start
- 1 May 2008 (actual)
- Primary completion
- 1 Jul 2012 (actual)
- Study completion
- 1 Jul 2012 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with definite IE treated in one of the participating hospitals.
Key inclusion criteria (2 listed)
- Major patient
- Definite IE caused by oral streptococci (case) or by non-oral pathogens (control)
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oral health status
Time frame: During the IE event
Dental and periodontal evaluation by a dental surgeon or a stomatologist, according to a protocol of standardized examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Aug 2018.
- Results publication: PubMed 28369398Duval 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis, run by Centre Hospitalier Universitaire de Besancon.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oral health status (time frame: During the IE event). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03612245, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Aug 2018.