NCT00057369Unknown2 期
Phase II, Randomized, Open-Label, Multi-Center Study to Evaluate the Safety and Efficacy of Dalbavancin Versus Vancomycin in the Treatment of Catheter-Related Bloodstream Infections With Suspected or Confirmed Gram-Positive Bacterial Pathogens
Vicuron Pharmaceuticals2 个研究点 分布在 1 个国家目标入组 88 人开始时间: 2001年2月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 88
- 试验地点
- 2
研究概览
简要总结
This is a study to evaluate a new medication dosed once a week in the treatment of bacterial infections in the blood from intravenous catheters (CR-BSI). The primary objective is to evaluate the efficacy and safety of dalbavancin in the treatment of adults with CR-BSI relative to a standard of care treatment, vancomycin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 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 patient or his/her legally authorized representative has given informed consent by means approved by the investigator's IRB/EC;
- •> 18 years of age;
- •Had one or more central venous catheters at the time initial signs of infection were evident;
- •Creatinine clearance <50 mL/min;
- •Bilirubin > 2x the upper limit of normal;
- •Treatment with an antibiotic effective against Gram-positive bacterial infections for more than 24 hours within 48 hours of study medication initiation,
- •Prolonged antibiotic therapy for CR-BSI anticipated (i.e., >2 weeks)
排除标准
- 未提供
研究者
研究点 (2)
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