Infective Endocarditis (IE) Clinical Trial
Official title:
Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis
Infective endocarditis (IE) is defined as a bacterial infection of the endocardium (inner
surface of the heart), which may include one or more heart valves. Epidemiologic pattern has
changed during the last 20 years whereas the incidence was unchanged. However, the mortality
increase despite recent diagnosis and therapeutic advances.
Only few investigations consider the prognostic and the therapeutic medical care according
to the clinical care pathway. In fact, 3 situations are observed: (i) patient for whom
diagnosis and medical care are realized in a referent center with cardiac surgery, (ii)
patients secondary addressed to a referent center with cardiac surgery, (iii) patients for
which the totality medical care are performed in non-referent health center. In addition,
epidemiologic studies concern only a part of IE, not including most of the time the patients
hospitalized in non-referent center.
The aim of the study was to determine the prognosis of threated patients according to the
clinical care pathway. Secondary objectives was (i) to evaluate the application of European
recommendations concerning trans-oesophageal echocardiogram (TOE), antibiotic treatment and
surgical practice, (ii) to compare the epidemiologic profile according to the type of
center.
For this, 300 patients addressed in the 22 French participating centers for a possible or
certain IE according to Duke Criteria were prospectively included during 3 years.
Patient data (clinical, demographical, biological, microbiological, echocardiographic and
evolutive data) were collected at the admission, during hospitalization, at discharge and
one-year follow up.
| Status | Recruiting |
| Enrollment | 300 |
| Est. completion date | December 2018 |
| Est. primary completion date | February 2018 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - adult with infective endocarditis episode according to Duke Criteria Exclusion Criteria: - Patients with a new episode of infective endocarditis that led to its prior inclusion in the study |
Time Perspective: Prospective
| Country | Name | City | State |
|---|---|---|---|
| France | Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone | Marseille |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique Hopitaux De Marseille |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | the all-cause one-year mortality according to the group | one year | No | |
| Secondary | the application of European recommendations | realization of trans-oesophageal echocardiogram (TOE) | one year | No |
| Secondary | antibiotic treatment | type and time of antibiotic treatment for common germ, | one year | No |
| Secondary | surgery | performing valve surgery and / or total extraction of an implanted pacemaker or defibrillator. | one year | No |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT02816307 -
Etiology of Endocarditis in Negative Blood Cultures
|
N/A |