DAPTO-SNAP: Daptomycin vs. Vancomycin for the Treatment of Methicillin Resistant S. Aureus Bacteremia
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 300
- 试验地点
- 28
- 主要终点
- Desirability of Outcome Ranking (DOOR)
研究概览
简要总结
This is an open label randomized controlled trial for patients with methicillin resistant S. aureus (MRSA) bloodstream infection which will directly compare the two most commonly used therapies, vancomycin and daptomycin.
This study is an approved sub-study of The Staphylococcus aureus Network Adaptive Platform (SNAP) trial (NCT05137119)
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
- •The participant must meet all inclusion and
排除标准
- •for the SNAP Platform (NCT05137119) and also the following inclusion and exclusion criteria:
- •Inclusion Criteria:
- •Methicillin-resistant S. aureus bacteremia
- •Exclusion Criteria:
- •Severe allergy or non-severe rash to vancomycin or daptomycin
- •Suspected or confirmed MRSA pneumonia
- •Known vancomycin minimum inhibitory concentration (MIC) greater than or equal to 2mg/L or daptomycin MIC greater than or equal to 1mg/L
研究组 & 干预措施
Daptomycin
Daptomycin given by injection at a dose determined by the treating clinicians but no less than 6mg/kg
干预措施: Daptomycin for Injection (Drug)
Vancomycin
Vancomycin given by injection at a dose determined by the treating clinicians to achieve a trough-based or AUC-based target
干预措施: Vancomycin (IV) (Drug)
结局指标
主要结局
Desirability of Outcome Ranking (DOOR)
时间窗: Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119)
Desirability of Outcome Ranking (DOOR) - an ordinal outcome with 5 levels defined: Rank 1 - Alive without complication Rank 2 - Alive with 1 complication Rank 3 - Alive with 2 complications Rank 4 - Alive with 3 complications Rank 5 - Dead Complications include: 1. Clinical failure: Absence of resolution of clinical signs and symptoms of S. aureus bacteremia such that no additional antibiotic therapy is required or anticipated. 2. Infectious Complications: Including new endocarditis; new evidence of other deep metastatic foci (e.g., osteomyelitis or deep abscess); relapse of MRSA bacteremia after a patient has sterilized their initial blood cultures; readmission for subsequent care of S. aureus bacteremia; need for unplanned source control procedures; change of therapy due to inadequate clinical response. 3. Serious adverse drug event (Common Terminology Criteria class 4) due to study drug OR adverse drug event (classes 1-3) leading to discontinuation of the study drug
次要结局
- Clinical failure(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Serious Adverse Event or Adverse Event Leading to Discontinuation(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- All cause mortality(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Infectious Complications(Day 90 post enrollment in the S. aureus Network Adaptive Platform Trial (NCT05137119))
- Drug Induced Myostitis(Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119))
- Eosinophilic pneumonia(Occurring while on therapy up to day 42 from enrollment in SNAP (NCT05137119))
研究者
Todd C. Lee MD MPH FIDSA
Associate Professor of Medicine
McGill University Health Centre/Research Institute of the McGill University Health Centre