NCT01037192已完成不适用
Evaluating the Use of Large-dose, Extended Interval Vancomycin Intravenous Administration for Skin and Soft Tissue Infections
Fraser Health1 个研究点 分布在 1 个国家目标入组 4 人开始时间: 2010年3月最近更新:
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Clinical Efficacy
研究概览
简要总结
Our hypothesis is that large-dose, extended-interval vancomycin (30 mg/kg IV q24h) administration provides non-inferior clinical efficacy and microbiological efficacy to standard vancomycin (15 mg/kg IV q12h) administration for skin and soft tissue infections in an outpatient setting.
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
- 19 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 19 to 70 years
- •Weight 40 - 80 kg
- •Suspected or confirmed skin or soft tissue infection for which vancomycin is indicated
- •Subject referred to or admitted into OPAT by an Infectious Disease Specialist or Emergency Physician
- •Subject able to provide informed consent
排除标准
- •Known history of allergy to vancomycin
- •Pregnancy
- •Granulocytopenia (< 1x109/L)
- •Renal impairment (serum creatinine > 177 µmol/L or eGFR < 50 mL/min)
- •Known history of vestibular disease or hearing loss
- •Subjects treated with vancomycin within the previous month
- •Subjects who have received more than 24 hours of vancomycin
- •Subjects receiving other antimicrobials that cover MRSA (e.g. cotrimoxazole, rifampin, linezolid)
研究组 & 干预措施
Vanco once daily
Experimental
Subject receives vancomycin 30 mg/kg dose
干预措施: vancomycin (Drug)
Vanco twice daily
Active Comparator
Subject receives vancomycin 15 mg/kg twice daily
干预措施: vancomycin (Drug)
结局指标
主要结局
Clinical Efficacy
时间窗: 5 days
Clinical efficacy is determined on the fifth and last day of therapy and is defined favourable if there is resolution of symptoms of infection, return to normal body temperature for at least 48 hours, and normalization or a decrease (\> 15%) in leukocytes.
次要结局
- Microbiological Efficacy(5 days)
研究者
Anna Yuen
Pharmacist
Fraser Health
研究点 (1)
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