Ciprofloxacin Versus Levofloxacin and Rate of Breakthrough Infections in Hematopoietic Stem Cell Transplant Patients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 308
- 试验地点
- 1
- 主要终点
- Proportion of Bloodstream Bacterial Infections
研究概览
简要总结
Ciprofloxacin and levofloxacin are both in guidelines to use for prophylaxis in autologous and allogeneic Stem cell transplant.Ciprofloxacin was recently replaced by levofloxacin as the preferred agent in some transplant centers. In some small retrospective studies ciprofloxacin prophylaxis was associated with a higher rate of breakthrough gram positive bloodstream infections. However, the optimum oral agent for antibacterial prophylaxis in transplant recipients remains uncertain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients 18-75 years of age with a diagnosis of a hematological malignancy. Meet the stem cell transplant program criteria to undergo autologous or allogeneic hematopoietic stem cell transplantation.
排除标准
- •Prolonged QT
- •Allergies to ciprofloxacin or levofloxacin
研究组 & 干预措施
Levo
Levofloxacin 500 mg once daily
干预措施: Levofloxacin (Drug)
Cipro
Ciprofloxacin 500 mg BID
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Proportion of Bloodstream Bacterial Infections
时间窗: 60 days post stem cell transplant
to assess proportion of bloodstream bacterial infections in the ciprofloxacin group compared to levofloxacin group up to day 60 after stem cell transplant
次要结局
未报告次要终点
研究者
Shatha Farhan
Principal Investigator
Henry Ford Health System