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临床试验/NCT02759978
NCT02759978Unknown不适用

Individualized Diagnosis of Endocarditis and Its Therapy With a Focus on Infected Prosthetic materiAL

University Medical Center Groningen1 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2016年5月最近更新:
适应症

试验速览

阶段
不适用
入组人数
300
试验地点
1
主要终点
30 day mortality

研究概览

简要总结

Infective endocarditis (IE) is a frequent and serious complication of implanted intracardiac prosthetic material, with a high morbidity and mortality. Therefore, this study aims to improve outcome of IE, with a focus on patients with intracardiac prosthetic material. In this study the investigators deal with research questions about both the diagnosis (microbiological, imaging, and expert opinion) and treatment of IE (with antimicrobial agents and surgical), in order to improve these clinical components and ultimately aim to improve outcome.

详细描述

Rationale

Infective endocarditis (IE) is a frequent and serious complication of implanted intracardiac prosthetic material, with a high morbidity and mortality. The number of procedures where prosthetic material is implanted in the heart increases, as do the age and comorbidity of treated subjects. In current clinical practice diagnosis of infected intracardiac prosthetic material is often difficult because of the lack of sensitivity of the available diagnostic armamentarium for IE.

As a general rule, first line treatment of intracardiac prosthetic material related endocarditis consists of surgical prosthesis removal, combined with appropriate antimicrobial therapy. The exception encompasses uncomplicated prosthetic valve endocarditis (PVE). PVE actually has a fair chance of successful medical treatment alone (>50%), depending on the causative micro-organism. Although there is evidence and consensus with regard to the first line treatment, surgical removal is not always possible because of its associated high risk, technical limitations, or unwillingness of patients to undergo an invasive surgical procedure. Second and third line treatments do not include surgery, and consist of antimicrobial therapy with biofilm-penetrating agents during a predetermined timespan (second line) or as life-long suppressive antimicrobial therapy (third line). These treatments are the alternative in situations wherein first line treatment is not feasible or is unwanted. Although not extensively investigated, these treatments are considered suboptimal.

Therefore further research is necessary. More research is needed to diagnose IE more accurate and prompt, as current diagnostic criteria (the modified Duke criteria) for IE are insufficient and as it is unclear how to best allocate non-invasive imaging techniques, especially for intracardiac prosthetic material. More research is also needed to verify the indications for and optimize the use of second and third line treatments in patients with intracardiac prosthetic material.

Objectives

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • patients presenting to participating hospitals
  • age ≥18 years
  • BSAC-criteria 2012: suspicion of infective endocarditis, retained in the differential diagnosis after clinical reasoning, without alternative diagnosis

排除标准

  • not fulfilling inclusion criteria

结局指标

主要结局

30 day mortality

时间窗: 30 days

Mortality after 30-days follow-up

Duration of antimicrobial therapy

时间窗: 30 days

Duration of antimicrobial therapy (including appropriateness of drug, dosing and dosing regimen)

IE clinical diagnosis

时间窗: 2 months

Number of clinically identified (prosthetic material related) endocarditis episodes, according to (multiple) constellation(s) of diagnostic criteria (the current gold standard of the modified Duke criteria, and newly set-up and to be investigated constellations of diagnostic elements)

Cardiac surgery

时间窗: 1 year

Cardiac surgery performed

Complications

时间窗: 1 year

Number of complications: congestive heart failure (CHF) or other hemodynamic consequences, septic emboli, metastatic infection

IE final diagnosis

时间窗: 1 year

Number of "true" prosthetic material related endocarditis episodes, according to expert opinion after follow-up (important components being findings during surgery and from pathology)

Relapse/recurrence

时间窗: 1 year

Number of relapses / recurrences

1 year mortality

时间窗: 1 year

Mortality after 1-year follow-up

次要结局

  • Adverse events(1 year)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Bhanu Sinha, MD, PhD

Principal Investigator

University Medical Center Groningen

研究点 (1)

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