Infective EndocarditisEI2008NCT03295045
Evolution of the Profile of Infectious Endocarditis in France in 2008 (EI2008)
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 (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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infective Endocarditis
- How many people
- 484 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2007to 31 Dec 2010
- 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: Inpatients with infective endocarditis living in one of the studied regions
Who may be able to join
- 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
Who cannot join
- Patients not living in one of the studied regions
About this study
Official title: Evolution of the Profile of Infectious Endocarditis in France in 2008
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.
- Conditions
- Infective Endocarditis
- Medical subject headings
- Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Vital status
Measured: 1 year
Secondary outcomes (1)
Frequency of antibiotic resistance by the germs (streptococci and staphylococci)
antibiotic treatments and outcome
Measured: during the hospitalization, 1 year maximum
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2017
- Study start1 Dec 2007
- Primary completion31 Dec 2009
- Study completion31 Dec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 484 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Besancon
- Sponsor type
- University, hospital or other
- 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
- Investigators
- Bruno HOEN, MD PhD, Principal investigator, Centre Hospitalier Universitaire de Pointe à Pitre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03295045
- Sponsor's protocol ID
- N/2007/50
- Acronym
- EI2008
- Status last verified
- Sep 2017
- First submitted
- 5 Sep 2017
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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 22492317Duval 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
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evolution of the Profile of Infectious Endocarditis in France in 2008
- ClinicalTrials.gov ID
- NCT03295045
- Acronym / sponsor ID
- EI2008 / N/2007/50
- Conditions
- Infective Endocarditis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 484 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de BesanconUniversity, hospital or other
- 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
- Study start
- 1 Dec 2007 (actual)
- Primary completion
- 31 Dec 2009 (actual)
- Study completion
- 31 Dec 2010 (actual)
- First posted
- 27 Sep 2017 (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 (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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatients with infective endocarditis living in one of the studied regions
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients not living in one of the studied regions
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
Mortality
Time frame: 1 year
Vital status
1 secondary outcome
Frequency of antibiotic resistance by the germs (streptococci and staphylococci)
Time frame: during the hospitalization, 1 year maximum
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 27 Sep 2017.
- Results publication: PubMed 22492317Selton-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.
- Results publication: PubMed 22624837Duval 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.
- 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.
Bruno HOEN, MD PhD principal investigator
Centre Hospitalier Universitaire de Pointe à Pitre
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 4 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 27 Sep 2017. 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?
Mortality (time frame: 1 year). 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 NCT03295045, which also lists 2 linked publications.
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 27 Sep 2017.