Effect of Systematic Search and Antimicrobial Treatment of Asymptomatic Bacteriuria in Kidney Transplant Recipients in the Incidence of Acute Pyelonephritis: a Pragmatic Prospective Randomized Controlled Study.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 112
- 主要终点
- Incidence of Pyelonephritis
研究概览
简要总结
Antimicrobial treatment of asymptomatic bacteriuria (AB) in kidney transplant recipients (KTR) is controversial. The investigators performed a comparative, parallel-group, randomized, open-label study to assess, in a real clinical setting, the feasibility of and benefit derived from systematic search and antimicrobial treatment of all episodes of AB.
详细描述
All patients undergoing KT between January 2011 and December 2013 in a tertiary-care center with an active transplantation program were systematically searched for AB within the first 2 years after transplantation on a regular basis. During the first 2 months after transplantation all episodes of AB were treated. Thereafter, patients were assigned, according to a computer-generated randomization sequence, to group A (systematic antimicrobial treatment of all episodes of AB) or group B (no treatment). Treatment was chosen according to the results of the urine culture.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients developing asymptomatic bacteriuria beyond 2 months after transplantation.
排除标准
- •<18 years old
- •Pregnant women
- •Kidney-pancreas transplantation
- •Double J stent catheterization at the momento of randomization
- •Permanent vesical catheter
结局指标
主要结局
Incidence of Pyelonephritis
时间窗: 2 years after transplantation
The number of patients that develope pyelonephritis in the first 2 years after transplantation in each group, divided by the number of patients allocated in each group at randomization.
次要结局
- Incidence of lower tract urinary infection(2 years after transplantation)
- Incidence of Clostridium difficile infection(2 years after transplantation)
- Incidence of multidrug resistant bacteria colonization/infection(2 years after transplantation)
- Long-term graft function(At 1 year and 2 years after transplantation)
研究者
Francisco López Medrano
Lopez-MedranoF
López-Medrano, Francisco, M.D.