Infective Endocarditis in the Elderly (ELDERL-IE)

January 5, 2024 updated by: Christine Selton-Suty, Central Hospital, Nancy, France

Infective Endocarditis in the Elderly: Description of the Geriatric Characteristics and Their Influence on Therapeutic Care and the Morbidity and Mortality at 3 Months (ELDERL-IE)

ELDERL-IE is a multicenter national prospective observational study.

The main objective is to describe geriatric characteristics (comorbidities, cognitive status, autonomy, nutritional status, balance and walking) in patients aged 75 years or older with infective endocarditis (IE).

The secondary objectives are to assess the impact of geriatric features on the medico - surgical care and on morbidity and mortality at 3 months after the end of the hospitalization, and to describe the initial clinical presentation and diagnostic modalities in the IE elderly.

Study Overview

Status

Completed

Conditions

Detailed Description

Population monitoring:

Clinical, therapeutic, biological, microbiological, echocardiographic and geriatric data are collected. (M-2/3 before inclusion; D-15 before inclusion; D0; M3; vital status at 1 year)

Study Type

Observational

Enrollment (Actual)

120

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
      • Nancy, France, 54000
        • Central Hospital - University Hospital

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

75 years and older (Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All patients older than 75 years are eligible if they are considered and treated as a case of IE by physicians ensuring their medical care.

Description

Inclusion Criteria :

  • all patients older than 75 years are eligible if they are considered and treated as a case of IE by physicians ensuring their medical care.
  • the patient should be treated in one of the clinical sites participating at the study.
  • the patient should benefit during initial hospitalization of a geriatric assessment, in addition to the usual clinical and therapeutic management of such patients.

Exclusion criteria :

  • patients not fulfilling the criteria of definite or possible endocarditis according to Duke modified by Li diagnostic classification that will be applied after collection of all the data at the discharge of the patient.

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline geriatric characteristics at 3 months
Time Frame: 3 months after inclusion
OMS score
3 months after inclusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Three months mortality
Time Frame: 3 months after inclusion
Mortality rate at 3 months
3 months after inclusion
One year mortality
Time Frame: 1 year after inclusion
Mortality rate at 1 year
1 year after inclusion
Change from baseline geriatric characteristics at 3 months
Time Frame: 3 months after inclusion
Karnofsky'score
3 months after inclusion
Change from baseline geriatric characteristics at 3 months
Time Frame: 3 months after inclusion
Score MNA
3 months after inclusion

Collaborators and Investigators

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

Sponsor

Central Hospital, Nancy, France

Collaborators

Fondation Cœur et Recherche

Investigators

  • Principal Investigator: Christine Selton-Suty, MD, Central Hospital, Nancy, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Actual)

March 1, 2015

Primary Completion (Actual)

June 1, 2016

Study Completion (Actual)

July 1, 2017

Study Registration Dates

First Submitted

August 25, 2016

First Submitted That Met QC Criteria

September 21, 2016

First Posted (Estimated)

September 22, 2016

Study Record Updates

Last Update Posted (Estimated)

January 8, 2024

Last Update Submitted That Met QC Criteria

January 5, 2024

Last Verified

January 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSS 2014/ELDERL-IE-SELTON/SR

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Infective Endocarditis

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Equatorial Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe