Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis

NCT ID: NCT02856607

Last Updated: 2016-08-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

300 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-02-28

Study Completion Date

2018-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Infective Endocarditis (IE)

Study Design

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Study Time Perspective

PROSPECTIVE

Study Groups

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Group I

patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery

determine the prognosis of threated patients according to the clinical care pathway.

Intervention Type OTHER

Group II

patients secondary addressed to a referent center with cardiac surgery

determine the prognosis of threated patients according to the clinical care pathway.

Intervention Type OTHER

Group III

patients for which the totality medical care are performed in non-referent health center

determine the prognosis of threated patients according to the clinical care pathway.

Intervention Type OTHER

Interventions

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determine the prognosis of threated patients according to the clinical care pathway.

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assistance Publique Hopitaux De Marseille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Urielle DESALBRES

Role: STUDY_DIRECTOR

Assistance Publique Hôpitaux de Marseille

Locations

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Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone

Marseille, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Gilbert HABIB

Role: CONTACT

04 91 38 75 87

Facility Contacts

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Gilbert HABIB

Role: primary

04 91 38 75 87

Other Identifiers

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RC12_3675

Identifier Type: -

Identifier Source: org_study_id

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