NCT00871104已完成4 期
Evaluation of the Efficacy and Safety of Fosfomycin Plus Imipenem for the Treatment of Methicillin-resistant Staphylococcus Aureus (MRSA) Infective Endocarditis.
Juan A. Arnaiz10 个研究点 分布在 1 个国家目标入组 50 人开始时间: 2009年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 10
- 主要终点
- Proportion of patients with negative blood cultures.
研究概览
简要总结
The study evaluates the efficacy and safety of fosfomycin and imipenem for the treatment of methicillin-resistant staphyloccocus aureus infective endocarditis in comparison to vancomycin, the standard therapy.
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
- •Suspected methicillin-resistant staphyloccocus aureus infective endocarditis on a native valve, prosthetic valve or pacemakers´s electrode or defibrillators with definitive or probable diagnosis by the modified Duke criteria (Li J, et al. Clin Infect Dis. 2000).
- •Patients over 18 years.
排除标准
- •Patients who did not sign informed consent.
- •Patients with active consumption intravenous drug.
- •Patients with emergent surgery criteria (<72 hours).
- •Patients or cardiogenic shock.
- •Patients with antibiotic active against MRSA over 72 hours or they may need another antibiotic active against MRSA than those in the study.
- •Patients with chronic renal failure on hemodialysis who received empirical treatment with vancomycin as a single dose and have a valley ≥ 15 mcg / mL on the third day.
- •Patients with MRSA strains resistant to fosfomycin (MIC> 64 mg / L) (<10%) or vancomycin (MIC> 2 mg / L) or with an MIC to vancomycin of 2 mg / L.
- •Patients with any formal contraindication to be treated with study drugs
- •Patients treated with any investigational drug within 30 days prior to entering the study.
研究组 & 干预措施
1
Experimental
IV fosfomycin and imipenem adjusted to renal function
干预措施: Fosfomycin and imipenem (Drug)
2
Active Comparator
IV Vancomycin twice a day with valley leves higher than 15 mcg/kg
干预措施: Vancomycin (Drug)
结局指标
主要结局
Proportion of patients with negative blood cultures.
时间窗: 7 days
次要结局
- Toxicity due to treatment(20 weeks)
研究者
Juan A. Arnaiz
MD, PhD
Hospital Clinic of Barcelona
研究点 (10)
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