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

August 2, 2016 updated by: Assistance Publique Hopitaux De Marseille

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

300

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Marseille, France, 13354
        • Recruiting
        • Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

all adults with infective endocarditis episode

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
the all-cause one-year mortality according to the group
Time Frame: one year
one year

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assistance Publique Hopitaux De Marseille

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2014

Primary Completion (ANTICIPATED)

February 1, 2018

Study Completion (ANTICIPATED)

December 1, 2018

Study Registration Dates

First Submitted

August 2, 2016

First Submitted That Met QC Criteria

August 2, 2016

First Posted (ESTIMATE)

August 5, 2016

Study Record Updates

Last Update Posted (ESTIMATE)

August 5, 2016

Last Update Submitted That Met QC Criteria

August 2, 2016

Last Verified

August 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RC12_3675

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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