French National Observatory on Infective Endocarditis
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 5,000
- 试验地点
- 1
- 主要终点
- diagnostic imaging
研究概览
简要总结
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.
详细描述
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).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •Refusal of the patient to participate.
结局指标
主要结局
diagnostic imaging
时间窗: inclusion
description of tyhe imaging tests performed
history of heart disease
时间窗: inclusion
status of heart valves, pre-existing heart conditions
clinical symptoms
时间窗: inclusion
cardiac, peripheral and neurological symptoms
risk factors, medical history
时间窗: inclusion
associated diseases
weight
时间窗: inclusion
kg
antibiotic therapy
时间窗: from inclusion to recovery
antibiotic treatment: type and duration
surgical procedures
时间窗: from inclusion to recovery
description of surgical procedures
origin of infection
时间窗: period of 3 months before infective endocarditis
high risk procedures
height
时间窗: inclusion
cm
biological outcomes
时间窗: inclusion
blood count
microbiological outcomes
时间窗: inclusion
identification of infecting organisms
次要结局
- biologic collection (optional)(inclusion)
研究者
Christine Selton-Suty
Dr
Central Hospital, Nancy, France