French National Observatory on Infective Endocarditis

Recruiting

• Conditions: Infective Endocarditis

• Registration Number: NCT03272724
• Lead Sponsor: Central Hospital, Nancy, France

Brief Summary

The objective of this observatory is to provide a national database of infective endocarditis, informed by all volunteer centers, using a standardized case report forms.

Such an observatory will describe the clinical profile, microbiological, therapeutic and evolving of infective endocarditis (IE); analyze the risk factors for the disease and its prognosis factors of evolution; describe management practices; evaluate and compare in the real drug treatment strategies (including antibiotics) and surgical.

Detailed Description

All the clinical, biological, microbiological and laboratory describing the history of patients and their evolution during hospitalization for infective endocarditis will be obtained from physicians supporting patients and recorded in an electronic case report form. Will include collected clinical characteristics (site, pre-existing heart disease underlying symptoms, complications), biological characteristics (dosage on admission and diagnosis), microbiological characteristics (identifying the genus and species of the microorganism responsible, sensitivity to antibiotics susceptibility testing and evaluated by determination of minimal inhibiting concentration (MIC), exhaustive search of the rare forms of endocarditis uncultivated microorganisms), an analysis of the gateways based on the causative organism; echocardiographic characteristics (number and size of vegetations, valvular damage, scalable: surgery, lethality) and therapeutic characteristics (antibiotic treatment, surgical).

Study Timeline

• Study Start: 1991-01-01
• Study First Submitted: 2017-08-28
• Study First Submitted QC: 2017-08-31
• Study First Posted: 2017-09-06
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-29
• Last Update Posted: 2024-03-04
• Primary Completion: 2024-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5000

Inclusion Criteria

• Major Patient
• Supported in one of the participating centers
• The application of diagnostic classification criteria of Duke modified by Li is carried out after collection of all the data at the end of the patient's hospitalization. Only patients meeting criteria for definite or possible endocarditis will be included in the analyses.
• Registered with the French social security system

Exclusion Criteria

• Refusal of the patient to participate.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
diagnostic imaging	inclusion	description of tyhe imaging tests performed
history of heart disease	inclusion	status of heart valves, pre-existing heart conditions
clinical symptoms	inclusion	cardiac, peripheral and neurological symptoms
risk factors, medical history	inclusion	associated diseases
weight	inclusion	kg
antibiotic therapy	from inclusion to recovery	antibiotic treatment: type and duration
surgical procedures	from inclusion to recovery	description of surgical procedures
origin of infection	period of 3 months before infective endocarditis	high risk procedures
height	inclusion	cm
biological outcomes	inclusion	blood count
microbiological outcomes	inclusion	identification of infecting organisms

Secondary Outcome Measures

Name	Time	Method
biologic collection (optional)	inclusion	plasma and serum collection

Trial Locations

Locations (1)

CHRU; 🇫🇷 Vandœuvre-lès-Nancy, France