NCT02910856

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2015

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

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

March 1, 2015

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

August 25, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

September 22, 2016

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
Last Updated

January 8, 2024

Status Verified

January 1, 2024

Enrollment Period

1.3 years

First QC Date

August 25, 2016

Last Update Submit

January 5, 2024

Conditions

Infective Endocarditis

Outcome Measures

Primary Outcomes (1)

  • Change from baseline geriatric characteristics at 3 months

    OMS score

    3 months after inclusion

Secondary Outcomes (4)

  • Three months mortality

    3 months after inclusion

  • One year mortality

    1 year after inclusion

  • Change from baseline geriatric characteristics at 3 months

    3 months after inclusion

  • Change from baseline geriatric characteristics at 3 months

    3 months after inclusion

Eligibility Criteria

Age75 Years+
Sexall
Healthy VolunteersNo
Age GroupsOlder Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Central Hospital - University Hospital

Nancy, 54000, France

Location

Related Publications (4)

  • Forestier E, Fraisse T, Roubaud-Baudron C, Selton-Suty C, Pagani L. Managing infective endocarditis in the elderly: new issues for an old disease. Clin Interv Aging. 2016 Sep 2;11:1199-206. doi: 10.2147/CIA.S101902. eCollection 2016.

    PMID: 27621607RESULT

  • Forestier E, Roubaud-Baudron C, Fraisse T, Patry C, Gavazzi G, Hoen B, Carauz-Paz P, Moheb-Khosravi B, Delahaye F, Sost G, Paccalin M, Nazeyrollas P, Strady C, Alla F, Selton-Suty C; AEPEI and the GInGer Elderl-IE study group; AEPEI and the GInGer Elderl-IE study group. Comprehensive geriatric assessment in older patients suffering from infective endocarditis. A prospective multicentric cohort study. Clin Microbiol Infect. 2019 Oct;25(10):1246-1252. doi: 10.1016/j.cmi.2019.04.021. Epub 2019 May 2.

    PMID: 31055167RESULT

  • Forestier E, Selton-Suty C, Roubaud-Baudron C. Managing infective endocarditis in older patients: do we need a geriatrician? Aging Clin Exp Res. 2021 Mar;33(3):719-722. doi: 10.1007/s40520-019-01400-6. Epub 2019 Nov 22.

    PMID: 31758501RESULT

  • N'cho-Mottoh MB, Erpelding ML, Roubaud C, Delahaye F, Fraisse T, Dijos M, Ennezat PV, Fluttaz A, Richard B, Beaufort C, Nazeyrollas P, Brasselet C, Pineau O, Tattevin P, Curlier E, Iung B, Forestier E, Selton-Suty C. The impact of transoesophageal echocardiography in elderly patients with infective endocarditis. Arch Cardiovasc Dis. 2023 May;116(5):258-264. doi: 10.1016/j.acvd.2023.04.001. Epub 2023 Apr 25.

    PMID: 37147149RESULT

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart DiseasesCardiovascular Diseases

Study Officials

  • Christine Selton-Suty, MD

    Central Hospital, Nancy, France

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Doctor

Study Record Dates

First Submitted

August 25, 2016

First Posted

September 22, 2016

Study Start

March 1, 2015

Primary Completion

June 1, 2016

Study Completion

July 1, 2017

Last Updated

January 8, 2024

Record last verified: 2024-01

Locations

FR(1)