NCT01034176已完成4 期
Effect of Fluoroquinolones on BK Viremia in the Renal Transplant Recipient, A Multi-Center Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 43
- 试验地点
- 8
- 主要终点
- Percent Change From Baseline in BK Virus Copies at 3 Months
研究概览
简要总结
Our hypothesis is that 30 days of oral levofloxacin (FDA approved antibiotic) in patients with persistent viremia (BK virus found in blood) will impair progress to BK virus induced kidney damage by significantly decreasing or eliminating BK virus in the blood.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Living and cadaveric kidney transplant recipients over the age of 18 years with BK viremia
排除标准
- •Female patients of childbearing age who are pregnant or in whom adequate contraception cannot be maintained.
- •Patients with active infections, history of malignancy/Posttransplant Lymphoproliferative Disease (PTLD) serologic positivity to HIV.
- •Patients with evidence of urinary tract obstruction causing allograft dysfunction, unless corrected by time of enrollment.
- •Patients with clinical or morphological evidence of recurrence of primary disease.
- •Patients with a history of allergic reaction to quinolone antibiotics.
- •Patients with history of prolong QT interval
- •Patients with recurrent hypoglycemic episodes
- •Patients with history of myasthenia gravis
- •Patients taking Thioridazine
研究组 & 干预措施
Levofloxacin
Active Comparator
Levofloxacin 500 mg every day (dose adjusted for renal function) for 30 days
干预措施: levofloxacin (Drug)
placebo
Placebo Comparator
placebo identical to levofloxacin drug daily for 30 days
干预措施: placebo (Drug)
结局指标
主要结局
Percent Change From Baseline in BK Virus Copies at 3 Months
时间窗: Baseline and 3 months
Percent change in BK virus copies/mL from Baseline to 3 months
次要结局
- Number of Patients With >50% Reduction in BK Virus Copies(Baseline and 6 months)
研究者
Anil K. Chandraker, MD
Medical Director of Renal Transplantation
Brigham and Women's Hospital
研究点 (8)
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