Infective Endocarditis in the Elderly

Infective Endocarditis Clinical Trial

— ELDERL-IE  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02910856
• Other study ID #: PSS 2014/ELDERL-IE-SELTON/SR
• Status: Completed
• Start date: March 2015
• Est. completion date: July 2017

Study information

• Verified date: January 2024
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: July 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 75 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endocarditis
• Endocarditis, Bacterial
• Infective Endocarditis

Locations

Country	Name	City	State
France	Central Hospital - University Hospital	Nancy

Sponsors (2)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France	Fondation Cœur et Recherche

Country where clinical trial is conducted

France, 

References & 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. — View Citation

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- — View Citation

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. — View Citation

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 echocar — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline geriatric characteristics at 3 months	OMS score	3 months after inclusion
Secondary	Three months mortality	Mortality rate at 3 months	3 months after inclusion
Secondary	One year mortality	Mortality rate at 1 year	1 year after inclusion
Secondary	Change from baseline geriatric characteristics at 3 months	Karnofsky'score	3 months after inclusion
Secondary	Change from baseline geriatric characteristics at 3 months	Score MNA	3 months after inclusion