Endocarditis InfectiveEPEINCT03211975
Study of the Prognosis of Infectious Endocarditis (EPEI)
An observational study of Endocarditis Infective, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in the endocardium. It remains a complicated disease to manage due to its low incidence, diagnostic difficulties, the change in epidemiology in recent decades and high mortality rates. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Endocarditis Infective
- What is being tested?
- To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses
- How many people
- 645 participants
- Where
- 1 siteFrance
- Study dates
- 27 Feb 2017to Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 certain infectious endocarditis according to Duke's criteria
Who may be able to join
- all patients with certain infectious endocarditis according to Duke's criteria, confirmed by the presence of evocative images on the transthoracic and / or transesophageal ultrasound or by the data collected on the surgical specimens.
Who cannot join
- Patients with an infection not meeting the Duke IE criteria.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens, Picardie, 80054
Christophe TRIBOUILLOY, PhD, +33322455885, tribouilloy.christophe@chu-amiens.fr
About this study
Official title: Study of the Prognosis of Infectious Endocarditis (EPEI): Prospective and Retrospective Follow-up of a Cohort of Patients Hospitalized for Infectious Endocarditis
Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in the endocardium. It remains a complicated disease to manage due to its low incidence, diagnostic difficulties, the change in epidemiology in recent decades and high mortality rates. The annual incidence is estimated at 3-10 cases per 100,000 people.
The epidemiology of AR has changed significantly in recent years due to new risk factors. Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor, decreased markedly in the industrialized countries, replaced by new predisposing factors: the presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50 Compared with the general population), hemodialysis, nosocomial infections, immunosuppression, increased use of injectable treatments and, above all, an aging population with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency.
Read more
The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes atypical especially in case of infection on prosthesis where the diagnosis is based mainly on the results of the blood cultures and the ultrasound data.
The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation.
The evolution of endocarditis and its prognosis vary according to many factors: the type of germ responsible, the precocity of the diagnosis, the existence of a complication, the site of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses, embolic, neurological, renal and septic complications. Despite improvements in diagnosis and therapeutic methods, diagnosis is sometimes difficult, management remains very complicated and morbidity and mortality remain high. Studies are still needed to study the prognosis and to determine the predictive factors for hospital mortality and long-term mortality.
- Conditions
- Endocarditis Infective
- Being tested
- To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
To study the evolution of the prognosis of infectious endocarditis on native valves and on prosthesesOther
To study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses
What is being measured
The primary outcome is the main question the study is designed to answer.
Analysis of hospital mortality and long-term overall mortality.
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jul 2017
- Study start27 Feb 2017
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endocarditis InfectiveStudies of the same condition, open and under way.
- More trials run by Centre Hospitalier Universitaire, AmiensThe 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
- 645 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03211975
- Sponsor's protocol ID
- RNI2016-30
- Acronym
- EPEI
- Status last verified
- Jun 2026
- First submitted
- 6 Jul 2017
- Last updated
- 15 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of the Prognosis of Infectious Endocarditis (EPEI): Prospective and Retrospective Follow-up of a Cohort of Patients Hospitalized for Infectious Endocarditis
- ClinicalTrials.gov ID
- NCT03211975
- Acronym / sponsor ID
- EPEI / RNI2016-30
- Conditions
- Endocarditis Infective
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 645 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 27 Feb 2017 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 11 Jul 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.
Infectious endocarditis (IE) is the localization and proliferation of blood-borne germs in the endocardium. It remains a complicated disease to manage due to its low incidence, diagnostic difficulties, the change in epidemiology in recent decades and high mortality rates. The annual incidence is estimated at 3-10 cases per 100,000 people.
The epidemiology of AR has changed significantly in recent years due to new risk factors. Indeed, the frequency of rheumatic heart disease, which was the first predisposing factor, decreased markedly in the industrialized countries, replaced by new predisposing factors: the presence of valvular prostheses or intracardiac materials (the risk of AR is multiplied by 50 Compared with the general population), hemodialysis, nosocomial infections, immunosuppression, increased use of injectable treatments and, above all, an aging population with an increase in degenerative diseases such as aortic stenosis and l Mitral insufficiency.
The diagnosis of IA is based on DUKE criteria. But the clinical presentation is sometimes atypical especially in case of infection on prosthesis where the diagnosis is based mainly on the results of the blood cultures and the ultrasound data.
The lesions visualized in ultrasound are: vegetations, abscesses, pseudo-aneurysms and fistulas constituting the degenerated abscess evolution, the perforation of the cusps of the native valve or the bioprosthesis giving rise to a jet of Eccentric regurgitation.
The evolution of endocarditis and its prognosis vary according to many factors: the type of germ responsible, the precocity of the diagnosis, the existence of a complication, the site of occurrence. These complications of endocarditis are frequent, sometimes revealing. EI is complicated by heart failure, atrioventricular conduction disorders, peri-vascular abscesses, embolic, neurological, renal and septic complications. Despite improvements in diagnosis and therapeutic methods, diagnosis is sometimes difficult, management remains very complicated and morbidity and mortality remain high. Studies are still needed to study the prognosis and to determine the predictive factors for hospital mortality and long-term mortality.
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
- patients with certain infectious endocarditis according to Duke's criteria
Key inclusion criteria (1 listed)
- all patients with certain infectious endocarditis according to Duke's criteria, confirmed by the presence of evocative images on the transthoracic and / or transesophageal ultrasound or by the data collected on the surgical specimens.
Key exclusion criteria (1 listed)
- Patients with an infection not meeting the Duke IE criteria.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| To study the evolution of the prognosis of infectious endocarditis on native valves and on prosthesesTo study the evolution of the prognosis of infectious endocarditis on native valves and on prostheses | Other | – |
Primary outcome
Analysis of hospital mortality and long-term overall mortality.
Time frame: 1 day
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Jun 2026.
Related trials for Endocarditis Infective
Not yet recruiting
Metabolic Profiling Among Patients Suspected of Infective Endocarditis - PPSIE Comparing Metabolomes of Bloodstream Infections Versus Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
CBCT vs OPT on the Oral Health Status at 12 Months of Patients Hospitalized for Infective Endocarditis.
Infective Endocarditis
RecruitingObservational study
Impact of Preoperative Dental Screening in Reducing Infective Endocarditis Risk in Transcatheter Aortic Valve Implantation Patients
Transcatheter Aortic Valve Implantation, Dental
RecruitingPhase 3
Rifampin-free Regimen Versus Rifampin-containing Regimen in the Treatment of Staphylococcal Prosthetic Valve Endocarditis
Infective Endocarditis
Not yet recruitingObservational study
AngioVac Aspiration Therapy Registry
Intracardiac Thrombus, Intracardiac Mass
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endocarditis Infective, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
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 1 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: looking for participants now, as of the sponsor's last update on 15 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Christophe TRIBOUILLOY, PhD (+33322455885, tribouilloy.christophe@chu-amiens.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analysis of hospital mortality and long-term overall mortality. (time frame: 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Jun 2026.