Partial Oral Treatment of Endocarditis
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 400
- 试验地点
- 8
- 主要终点
- The primary endpoint is a composite endpoint including all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen
研究概览
简要总结
Background Current management of infective endocarditis include admission and treatment with parenteral antibiotics for 4 weeks - 6 weeks. Resource demands and psychological issues of present management strategy make it highly relevant to seek for alternative more lenient alternatives. Experiences with oral treatment are only sporadically described, but observational data suggest that oral treatment could be a feasible option. The investigators have in 2010 treated 12 endocarditis patients with partial oral antibiotics with a 100% success rate.
Study design The POET study is a Danish multicenter, prospective, randomized, open label study. The primary aim is to show non-inferiority of partial oral treatment with antibiotics of endocarditis compared to full parenteral treatment. Stable patients (n=400) with streptococci, staphylococci or enterococci infecting the mitral valve or the aortic valve will be included. After a minimum of 10 days of parenteral treatment, patients will be randomized to oral therapy or parenteral therapy. Special recommendations for oral treatment have been developed based on expected minimal inhibitory concentrations and pharmacokinetic calculations. Patients will be followed for 6 months after completion of antibiotic therapy. The primary endpoint is a composition of all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
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
- •Left-sided endocarditis based on the Duke criteria
- •Infected with one of the following microorganisms:
- •Streptococci
- •Enterococcus faecalis
- •Staphylococcus aureus
- •Coagulase-negative staphylococci.
- •≥ 18 years
- •At least 10 days of appropriate parenteral antibiotic treatment overall, and at least 1 week of appropriate parenteral treatment after valve surgery
- •Afebrile (T < 38.0) > 2 days
- •Decreasing infection parameters (CRP dropped to less than 25% of peak value or < 20 mg/l, and white blood cell count < 15 x 109/l) during antibiotic treatment
- •No sign of abscess formation by echocardiography
- •Transthoracic and transoesophageal echocardiography performed within 48 hours prior to randomization
排除标准
- •Body mass index > 40
- •Concomitant infection requiring intravenous antibiotic therapy
- •Inability to give informed consent to participation
- •Suspicion of reduced absorption of oral treatment due to abdominal disorder
- •Reduced compliance
研究组 & 干预措施
Oral treatment with antibiotics
Oral treatment with antibiotics based on resistens pattern
干预措施: Oral treatment with antibiotics for endocarditis (Drug)
Guideline treatment with parenteral antibiotics
Guideline treatment with parenteral antibiotics
干预措施: Guideline treatment with parenteral antibiotics (Drug)
结局指标
主要结局
The primary endpoint is a composite endpoint including all cause mortality, unplanned cardiac surgery, embolic events and relapse of positive blood cultures with the primary pathogen
时间窗: Approximately 7 months. From randomisation until 6 months after end of study medication
次要结局
- Cost of treatment(Approximately 7 months. From randomisation until 6 months after end of study medication)
- Complications related to intravenous catheter(6 weeks)
- Duration of antibiotic therapy(Approximately 7 months. From randomisation until 6 months after end of study medication)
- Quality of life(Approximately 7 months. From randomisation until 6 months after end of study medication)
研究者
Kasper Iversen
Consultant
Rigshospitalet, Denmark