Cardiac Implantable Electronic Device Lifelong Antibiotic thErapy vs Stop and See The CIEDLESS Study A Prospective Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 90
- 试验地点
- 2
- 主要终点
- Composite endpoint of death or relapse bacteremia
研究概览
简要总结
The goal of this non-randomized prospective study is to test whether 6-weeks antibiotic treatment can cure an cardiac implantable electronic device (CIED) infection in patients where device extraction is not feasible.
The main question it aims to answer:
• Is 6-weeks medical therapy effective in curing definite CIED infection with device retention?
Participants will discontinue the antibiotic treatment after at least 10 days iv antibiotic therapy and then per oral treatment to at least 6 weeks total. After discontinuation of antibiotics, patients are closely observed for bacterial relapse.
For patients who are not interested in participation and who do not have exclusion criteria, we will ask for consent into a registry as we wish to compare patients undergoing discontinuation of antibiotics with patients undergoing standard treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Definite CIED infection by the EHRA criteria
- •Deemed non-eligible for CIED extraction
排除标准
- •Unavailable for follow-up (e.g., tourist)
结局指标
主要结局
Composite endpoint of death or relapse bacteremia
时间窗: 12 months
Composite endpoint of all-cause mortality or relapse bacteremia with the primary pathogen
次要结局
- Death(12 months)
- Device extraction(12 months)
- Readmission for any cause(12 months)
- Change in quality of life(12 months)
研究者
Emil Loldrup Fosbol
Professor
Rigshospitalet, Denmark