Vancomycin Versus Daptomycin for the Treatment of Methicillin-resistant Staphylococcus Aureus Bacteremia Due to Isolates With High Vancomycin Minimum Inhibitory Concentrations (MICs)
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 11
- 主要终点
- Number of Participants With Clinical Success at Test of Cure Visit.
研究概览
简要总结
There is an increased failure rate for the treatment of Staphylococcus Aureus Bacteremia (SAB) with traditional doses of vancomycin, the standard of care for patients with MRSA bacteremia over the last 40 years. This has been largely attributed to isolates with increased resistance to vancomycin (increased MIC). Daptomycin is an antibiotic that was approved several years ago for the treatment of SAB and is being increasingly used for MRSA bacteremia due to isolates with increased MIC. Increased doses have been recommended for both of these drugs in the treatment of this infection without a trial demonstrating their relative efficacy or safety at higher doses. This study will randomize patients with SAB due to MRSA with an increased MIC to determine the relative efficacy and safety of vancomycin and daptomycin used at higher than traditional doses.
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
- •18 years of age or older
- •Signed informed consent
- •All cases of suspected MRSA bacteremia as determined by a patient with at least one blood culture growing gram-positive cocci in clusters with a clinical syndrome consistent with true bacteremia including fever, hypothermia (temperature < 36.0º C), tachycardia (heart rate > 100 beats/minute), hypotension (systolic blood pressure < 90 mm Hg) or other clinical features of sepsis.
- •All cases of right-sided native valve endocarditis due to MRSA
- •Patients who are diagnosed with left-sided native valve endocarditis after randomization will be continued in the study
- •Patients with MRSA bacteremia associated with infected foreign bodies, including vascular prostheses, orthopedic prostheses
排除标准
- 未提供
研究组 & 干预措施
High dose vancomycin
Vancomycin dosed to achieve a trough of 15-20 microgram/mL.
干预措施: Vancomycin (Drug)
High-dose daptomycin
Daptomycin dosed at 8 mg/kg/daily (every 48 hours in end-stage renal disease)
干预措施: Daptomycin (Drug)
结局指标
主要结局
Number of Participants With Clinical Success at Test of Cure Visit.
时间窗: 30-42 days post-treatment
Clinical success is the absence of treatment failures. Treatment failures will include death, clinical failure, microbiologic failure, or an adverse event requiring a change in therapy or discontinuation in therapy.
次要结局
- Adverse Event Rate in Each Arm, Including the Nephrotoxicity and Skeletal Muscle Toxicity(30-42 days post-treatment)
研究者
Leonard B. Johnson
Division Chief
St. John Health System, Michigan