NCT02856607

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
300

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2014

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

August 2, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

August 5, 2016

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2018

Completed
10 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

August 5, 2016

Status Verified

August 1, 2016

Enrollment Period

4 years

First QC Date

August 2, 2016

Last Update Submit

August 2, 2016

Conditions

Infective Endocarditis (IE)

Outcome Measures

Primary Outcomes (1)

  • the all-cause one-year mortality according to the group

    one year

Secondary Outcomes (3)

  • the application of European recommendations

    one year

  • antibiotic treatment

    one year

  • surgery

    one year

Study Arms (3)

Group I

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

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

Group II

patients secondary addressed to a referent center with cardiac surgery

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

Group III

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

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

Interventions

determine the prognosis of threated patients according to the clinical care pathway.OTHER
Group IGroup IIGroup III

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

all adults with infective endocarditis episode

You may qualify if:

  • \- adult with infective endocarditis episode according to Duke Criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone

Marseille, 13354, France

RECRUITING

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Urielle DESALBRES

    Assistance Publique Hôpitaux de Marseille

    STUDY DIRECTOR

Central Study Contacts

Gilbert HABIB

CONTACT

04 91 38 75 87gilbert.habib@ap-hm.fr

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 2, 2016

First Posted

August 5, 2016

Study Start

February 1, 2014

Primary Completion

February 1, 2018

Study Completion

December 1, 2018

Last Updated

August 5, 2016

Record last verified: 2016-08

Locations

FR(1)