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

• Conditions: Infective Endocarditis (IE)
• Interventions: Other: determine the prognosis of threated patients according to the clinical care pathway.

• Registration Number: NCT02856607
• Lead Sponsor: Assistance Publique Hopitaux De Marseille

Brief Summary

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

Not available

Study Timeline

• Study Start: 2014-02
• Status Verified: 2016-08
• Study First Submitted: 2016-08-02
• Study First Submitted QC: 2016-08-02
• Last Update Submitted: 2016-08-02
• Study First Posted: 2016-08-05
• Last Update Posted: 2016-08-05
• Primary Completion: 2018-02
• Study Completion: 2018-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Group II	determine the prognosis of threated patients according to the clinical care pathway.	patients secondary addressed to a referent center with cardiac surgery
Group III	determine the prognosis of threated patients according to the clinical care pathway.	patients for which the totality medical care are performed in non-referent health center
Group I	determine the prognosis of threated patients according to the clinical care pathway.	patient for whom diagnosis and medical care are realized in a referent center with cardiac surgery

Primary Outcome Measures

Name	Time	Method
the all-cause one-year mortality according to the group	one year

Secondary Outcome Measures

Name	Time	Method
the application of European recommendations	one year	realization of trans-oesophageal echocardiogram (TOE)
antibiotic treatment	one year	type and time of antibiotic treatment for common germ,
surgery	one year	performing valve surgery and / or total extraction of an implanted pacemaker or defibrillator.

Trial Locations

Locations (1)

Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone; 🇫🇷 Marseille, France