Antibiotic Treatment Versus no Therapy in Kidney Transplant Recipients With Asymptomatic Bacteriuria. A Prospective Randomized Study.
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 200
- 试验地点
- 2
- 主要终点
- To determine the incidence of pyelonephritis in both groups
研究概览
简要总结
Objective: To determine whether antibiotic treatment of asymptomatic bacteriuria in kidney transplant recipients could be useful to prevent pyelonephritis in these patients.
详细描述
Design: Randomized prospective study. Setting: University Hospital with an active kidney transplantation program. Patients: Adult kidney transplant recipients. Interventions: Kidney transplant recipients with asymptomatic bacteriuria will be randomly assigned to be treated with antibiotics or to be followed without antibiotic therapy.
Measurements: Urine cultures will be collected weekly during the first month after transplantation, every 2 weeks until three months after transplantation, every month until 6 months after transplantation and every 3 months until 12 months after transplantation. Urine culture will be as well collected if urinary symptoms appeared.
Primary end points: To determine in both groups: the incidence of pyelonephritis.
Secondary end points: To determine outcomes in both groups (renal function, hospitalization, rejection, graft loss, opportunistic infections and mortality) and infection by multiresistant microorganisms.
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 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients who receive a transplant allograft during study period
排除标准
- •No acceptation of study
研究组 & 干预措施
Antibiotic treatment
Kidney transplant recipients with asymptomatic bacteriuria will be treated with antibiotics.
干预措施: Antibiotic treatment (Drug)
No treatment
Kidney transplant recipients with asymptomatic bacteriuria will be followed without antibiotic therapy
干预措施: No treatment (Other)
结局指标
主要结局
To determine the incidence of pyelonephritis in both groups
时间窗: First year after kidney transplantation
次要结局
- Renal function(First year after kydney transplantation)
- Need for hospitalization(First year after kydney transplantation)
- Incidence of graft loss(First year after kidney transplantation)
- Mortality(First year after kidney transplantation)
研究者
Núria Sabé Fernàndez
Infectious Diseases Phisycian
Hospital Universitari de Bellvitge