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

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

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

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 Summary:
Sponsor: Assistance Publique Hopitaux De Marseille

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

Original Primary Outcome: Same as current

Current Secondary Outcome:

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

Original Secondary Outcome: Same as current

Information By: Assistance Publique Hopitaux De Marseille

Dates:
Date Received: August 2, 2016
Date Started: February 2014
Date Completion: December 2018
Last Updated: August 2, 2016
Last Verified: August 2016