Quinolone Prophylaxis for the Prevention of BK Virus Infection in Kidney Transplantation: A Pilot Study
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 154
- 试验地点
- 11
- 主要终点
- Occurrence of BK Viruria
研究概览
简要总结
Primary Research Questions:
Efficacy, safety and feasibility of a 3-month course of levofloxacin in a pilot study will be assessed.
- Under efficacy, this pilot will determine whether levofloxacin can decrease the incidence of BK viruria and peak urine BK viral load.
- Under safety, this pilot will determine the incidence of adverse events with levofloxacin.
- Under feasibility, this pilot will determine the number of kidney transplant patients randomized over an eight month enrolment period, adherence to the levofloxacin and frequency of patient drop-out and loss to follow-up
详细描述
BK virus infection has emerged as a major complication in renal transplantation leading to a significant reduction in graft survival. There are currently no proven strategies to prevent or treat BK virus infection. Quinolone antibiotics, such as levofloxacin, have demonstrated activity against BK virus. The investigators hypothesize that administration of a quinolone antibiotic, when given early post-transplantation, will prevent the establishment of BK viral replication in the urine and thus prevent systemic BK virus infection. A non-randomized study in kidney transplant recipients found that patients given levofloxacin or ciprofloxacin had a significantly lower incidence of BK viremia compared to those not receiving a quinolone (4% versus 24.5%, P=0.02).
Objective
The primary objective of the full trial will be to determine if the quinolone levofloxacin decreases the occurrence of doubling creatinine, transplant failure or death in kidney transplant recipients. The aim of this pilot trial is to assess the efficacy, safety and feasibility of a 3-month course of levofloxacin in the kidney transplant population.
Results from this pilot study will provide vital information to design and conduct a large, multi-centre trial to determine if quinolone therapy decreases meaningful clinical outcomes in kidney transplantation. If levofloxacin significantly reduces BK viruria and urine viral loads in kidney transplantation it will provide important justification of biologic effect to progress to the larger trial. If the full trial shows that levofloxacin significantly reduces BK infection and improves outcomes, its use in renal transplantation will be strongly endorsed given the lack of proven therapies for this condition.
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
- 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
- •a primary or repeat kidney transplant recipient (deceased or living donor)
- •age greater or equal to 18 years
排除标准
- •Unable to provide informed consent
- •Greater than 5 days post-transplantation
- •BK virus nephropathy with a previous transplant
- •History of allergic reaction to any quinolone antibiotic
- •History of quinolone associated tendonitis or tendon rupture
- •Corrected QT interval prolongation on EKG as defined by Al-Khatib
- •Concomitant use of medication known to prolong the QT interval such as class IA antiarrhythmic drugs (e.g. quinidine, procainamide, disopyramide), class III antiarrhythmic drugs (e.g. amiodarone, sotalol), azole antifungals (e.g. fluconazole) or macrolide antibiotics (e.g. erythromycin)
- •Pregnant or breastfeeding as safety of levofloxacin not established
- •Requires quinolone antibiotic for more than 14 days (e.g. for UTI prophylaxis)
- •Recipient of a multi-organ transplant (e.g. kidney-pancreas)
- •Currently enrolled in another interventional trial
- •Previously enrolled in this study
- •History of rhabdomyolysis
- •Significant allergic reaction to ≥ 3 classes of antibiotics as these patients may have no other option other than quinolones for routine infection.
研究组 & 干预措施
sugar pill
干预措施: Levofloxacin (Drug)
levofloxacin
干预措施: Levofloxacin (Drug)
结局指标
主要结局
Occurrence of BK Viruria
时间窗: 12 months post-transplantation
BK viruria was defined as 500 copies/mL or more of BK virus DNA in the urine.
次要结局
- Adverse Events(12 months)
- Clostridium Difficile Associated Diarrhea(12 months)
- Adherence(12 months)
- Infections(12 months)
- Allograft Loss(12 months)
- Mortality(12 months)
- Proportion of Patient Drop-out and Loss to Follow-up(12 months)
- Acute Rejection(12 months)
- Quantitative BK Urine Viral Load(12 months)
- BK Viremia(12 months)
- Quinolone Resistance(12 months)
- Use of Quinolones(12 months)