Daptomycin as Adjunctive Therapy for Staphylococcus Aureus Bacteremia
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 102
- 试验地点
- 1
- 主要终点
- Blood culture clearance
研究概览
简要总结
The purpose of our study is to examine the effects of a second antibiotic, daptomycin, in combination with a beta lactam antibiotic on treating bloodstream infection caused by methicillin-susceptible S. aureus.
详细描述
When patients have a blood infection with methicillin-susceptible S. aureus, they will all be treated with the usual standard of care, including abeta-lactam antibiotic, have their blood tested daily for the presence of the infection until they test negative, as well as an ultrasound of the heart to rule out an infection of the heart valves, as well as have any catheters removed (if possible) to ensure adequate control of the infection.
This study involves adding a second antibiotic, daptomycin, to the treatment regimen of half of the patients enrolled in this study. Daptomycin is approved by Health Canada for treating blood infections due to Staphylococcus aureus. It is currently not used in combination with a beta-lactam for these infections because there is insufficient evidence of benefit to justify the cost.
The study participants will receive an additional daily iv therapy which will consist of either daptomycin or a placebo for a total of five days while admitted to the hospital. During this time, the participants will continue to have their blood drawn to assess for the presence of bacteria. The participants' liver and muscle enzymes will also be measured on the first and fifth day of therapy to test for potential side effects of the daptomycin.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Patient has a methicillin susceptible Staphylococcus aureus bacteremia.
排除标准
- •Underlying terminal illness
- •Significant contraindication to beta-lactam therapy (i.e. severe allergy, severe adverse drug reaction)
- •Expected death before 5 days
- •Microbiologically confirmed need for concomitant VANCOMYCIN or DAPTOMYCIN
研究组 & 干预措施
Placebo
51 patients receiving a daily placebo infusion for five days on top of standard of care treatment for methicillin-sensitive Staphylococcus aureus (MSSA) bacteremia
干预措施: Placebo (Other)
Daptomycin
51 patients receiving daily daptomycin infusion for five days on top of standard of care treatment for MSSA bacteremia
干预措施: Daptomycin (Drug)
结局指标
主要结局
Blood culture clearance
时间窗: 5 days
Time between first positive and first negative blood culture
次要结局
- Mortality(30 days)
- Metastatic infection(30 days)
- Adverse Reactions(5 days)
- Intensive care admission(30 days)
- Recurrent infection(30 days)
研究者
Todd Lee
Doctor
McGill University Health Centre/Research Institute of the McGill University Health Centre