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

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ClinicalTrials.gov Identifier: NCT02856607
Recruitment Status : Unknown
Verified August 2016 by Assistance Publique Hopitaux De Marseille.
Recruitment status was:  Recruiting
First Posted : August 5, 2016
Last Update Posted : August 5, 2016
Sponsor:
Information provided by (Responsible Party):
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.


Condition or disease Intervention/treatment
Infective Endocarditis (IE) Other: determine the prognosis of threated patients according to the clinical care pathway.

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Study Type : Observational
Estimated Enrollment : 300 participants
Time Perspective: Prospective
Official Title: Impact of Clinical Care Pathway on Prognosis and Therapeutic Medical Care of Infective Endocarditis
Study Start Date : February 2014
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endocarditis

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.



Primary Outcome Measures :
  1. the all-cause one-year mortality according to the group [ Time Frame: one year ]

Secondary Outcome Measures :
  1. the application of European recommendations [ Time Frame: one year ]
    realization of trans-oesophageal echocardiogram (TOE)

  2. antibiotic treatment [ Time Frame: one year ]
    type and time of antibiotic treatment for common germ,

  3. surgery [ Time Frame: one year ]
    performing valve surgery and / or total extraction of an implanted pacemaker or defibrillator.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
all adults with infective endocarditis episode
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02856607


Contacts
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Contact: Gilbert HABIB 04 91 38 75 87 gilbert.habib@ap-hm.fr

Locations
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France
Assistance Publique Hôpoitaux de Marseille Hôpital de la Timone Recruiting
Marseille, France, 13354
Contact: Gilbert HABIB    04 91 38 75 87    gilbert.habib@ap-hm.fr   
Sponsors and Collaborators
Assistance Publique Hopitaux De Marseille
Investigators
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Study Director: Urielle DESALBRES Assistance Publique Hôpitaux de Marseille
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Responsible Party: Assistance Publique Hopitaux De Marseille
ClinicalTrials.gov Identifier: NCT02856607    
Other Study ID Numbers: RC12_3675
First Posted: August 5, 2016    Key Record Dates
Last Update Posted: August 5, 2016
Last Verified: August 2016
Additional relevant MeSH terms:
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Endocarditis, Bacterial
Endocarditis
Heart Diseases
Cardiovascular Diseases
Bacterial Infections
Cardiovascular Infections
Infection