NCT01871753已完成4 期
The Bacteriuria in Renal Transplantation (BiRT) Study: A Prospective, Randomized, Parallel-group, Multicenter, Open-label, Superiority Trial Comparing Antibiotics Versus no Treatment in the Prevention of Symptomatic Urinary Tract Infection in Kidney Transplant Recipients With Asymptomatic Bacteriuria
Erasme University Hospital30 个研究点 分布在 2 个国家目标入组 198 人开始时间: 2014年4月1日最近更新:
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 198
- 试验地点
- 30
- 主要终点
- cumulative incidence of a first episode of symptomatic urinary tract infection
研究概览
简要总结
The purpose of this study is to compare antibiotics versus no-treatment in kidney transplant recipients with asymptomatic bacteriuria.
详细描述
The BiRT trial investigators would be interested to collaborate with some additional hospitals, particularly centers having high level of antimicrobial resistance.
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
- 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
- •Kidney transplant recipient with asymptomatic bacteriuria after the first two months post-transplantation
排除标准
- •Pregnant women or women who wish to become pregnant during the course of the study
- •Presence of indwelling urinary devices such as urethral catheter, ureteral catheter, nephrostomy and/or suprapubic catheter
- •Combined transplantation (liver-kidney, lung-kidney, heart-kidney)
- •Urinary tract surgery during the last two months
- •Surgical urological procedure planned in the next 2 weeks
- •Neutropenia (≤ 500 neutrophils/mm3)
- •Important intensification of immunosuppression (Solumedrol bolus and/or use of thymoglobulin) or any other treatment of an acute graft rejection in the last two months
- •Use of antibiotics at the time of the asymptomatic bacteriuria (except for prevention of Pneumocystis jirovecii)
- •End-Stage Renal Disease (ESRD) requiring dialysis
- •Non-functioning native bladder (e.g. bladder dysfunction requiring intermittent self-catheterization, orthotopic ileal neobladder)
- •Recurrent acute graft pyelonephritis (≥ 2 episodes in the last year)
- •Kidney transplant recipients who could not return for regular follow-up
研究组 & 干预措施
Antibiotics
Experimental
10 days of antibiotics, started and selected according to the antibiogram results. In case of reinfection or relapse, re-administration of antimicrobial agents will be performed according to the antibiogram results (for a maximum of 3 cycles of ten days of antibiotics during the 12 months of the follow-up).
干预措施: Anti-Infective Agents (Other)
No treatment
No Intervention
no antibiotics delivered in case of asymptomatic bacteriuria, independently of the number of asymptomatic episodes.
结局指标
主要结局
cumulative incidence of a first episode of symptomatic urinary tract infection
时间窗: 12 months
次要结局
- incidence of a first episode of pyelonephritis(12 months)
- patient survival(12 months)
- total number of days of antimicrobial therapy(12 months)
- level of antimicrobial resistance in bacteria responsible for symptomatic urinary tract infections(12 months)
- graft function/graft survival(12 months)
- cost of antimicrobial treatment for asymptomatic bacteriuria and symptomatic urinary tract infection(12 months)
- clearance of asymptomatic bacteriuria(12 months)
- occurrence of new episodes of asymptomatic bacteriuria(12 months)
- incidence of graft rejection(12 months)
- utility of a control urine culture for diagnosis of asymptomatic bacteriuria in kidney transplant recipients(12 months)
- total number of symptomatic urinary tract infections in both groups(12 months)
- number of hospitalizations for asymptomatic bacteriuria and symptomatic urinary tract infection treatment(12 months)
研究者
Julien Coussement, MD
Julien Coussement, MD
Erasme University Hospital
研究点 (30)
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