NCT02113774Unknown4 期
The Impact of Antimicrobial Treatment for Asymptomatic Bacteriuria in Renal Transplant Patients
适应症
试验速览
- 阶段
- 4 期
- 主要终点
- development of symptomatic urinary tract infection
研究概览
简要总结
The investigators hypothesize that antibiotic therapy for asymptomatic bacteriuria in renal transplant patients does not have impact on the development of symptomatic urinary tract infection (UTI) or progression of renal impairment in patients during the first year after transplantation.
研究设计
- 研究类型
- Interventional
- 主要目的
- Treatment
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
- •Patients who are ≥1 month and ≤ 12 months after renal transplantation.
- •Positive urine culture defined as ≥ 105 colony forming units (CFU) per milliliter of a known single pathogen.
排除标准
- •Any one of the following signs and symptoms: fever, abdominal pain, dysuria, frequency, urgency, flank pain, costovertebral-angel tenderness or tenderness over the transplanted kidney
- •Active infections in another site
- •Leucocytosis (WBC >18.000K/micl) or leucopenia (WBC < 3.000 K/micl)
- •Elevation of serum creatinine of more than 15% of its baseline level
- •Obstructive or other urological complications following transplantation as known foreign device (stent/double-J-Cath, any catheter) in the urinary tract system, known obstruction of the transplanted kidney, indwelling or intermittent catheterization
- •Pregnant or lactating women.
- •Candidates to invasive urologic procedures.
- •Inability to return for regular follow up.
- •Previous enrollment in this study.
- •Patients who incapable of giving informed consent.
结局指标
主要结局
development of symptomatic urinary tract infection
时间窗: 30 days
次要结局
- 25% reduction in estimated glomerular filtration rate (eGFR)(1 year)
研究者
Ruth Rahamimov
head of transplant investigator service
Rabin Medical Center
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