A Prospective Randomized Trial of 2 Weeks vs 3 Months of Antibiotics Post Percutaneous Nephrolithotomy for the Prevention of Infection-Related Kidney Stones
试验速览
- 阶段
- 4 期
- 入组人数
- 28
- 试验地点
- 12
- 主要终点
- any recurrent kidney stones
研究概览
简要总结
The aim of this research is to determine an effective antibiotic regimen following definitive surgical therapy of kidney stones caused by bacterial infection (struvite stones).
详细描述
Struvite stones or infection stones are a subset of kidney stones that are related to bacterial infection. They only make up 15% of all kidney stones, but account for a much higher percentage of mortality (up to 67%) compared to other stones-due to the infectious component. Treatment is to ensure 100% eradication of the stone with surgery followed by antibiotics to eliminate the infection. Failure to eliminate the bacteria results in the stone growing back quickly. It is unknown how long antibiotics should be administered immediately after surgery-some urologists give 2-4 weeks while others give 2-3 months. We seek to randomize patients to receive 2 weeks of antibiotics or 3 months of antibiotics after surgery to remove all the kidney stones. We will see patients at 3, 6, and 12 months with x-rays and to test their urine for bacterial infections. This is a multi-centre study with participating 12 sites across North America.
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
- 19 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or Female.
- •No age restriction.
- •Diagnosed with an infection related stone.
- •Medically fit for definitive surgical management of stone.
- •Life expectancy greater than one year.
- •Stone free after definitive surgical therapy defined as fragments less than 3mm.
排除标准
- •Patients with medical comorbidities preventing them from definitive surgical therapy.
- •Patients with persistent stone burden following definitive surgical therapy.
研究组 & 干预措施
Arm A: 2 weeks Abx post PCNL
Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose.
干预措施: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin (Drug)
Arm B: 12 weeks/3 months Abx post PCNL
Oral antibiotics: ciprofloxacin, cotrimoxazole-trimethoprim, or macrodantin are administered for 2 weeks at full dose followed by a suppressive dose for another 10 weeks (total = 12 weeks or 3 months).
干预措施: ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin (Drug)
结局指标
主要结局
any recurrent kidney stones
时间窗: 6 months
Radiologic recurrence of calculi in the location of original treatment at or before 6 months following definitive surgical therapy.
次要结局
- UTI(1 year)
- treated site stone recurrence rates(1 year)
- Clostridiuum difficile colitis(1 year)
- ER visit(POD1)
- Readmission for sepsis.(3 months)
- Readmission for renal colic(3 months)
- Morbidity or mortality related to sepsis or renal failure(3 months)
- Repeat surgical procedures for stone recurrence(3 months)
- Ancillary procedures for stones such as ureteric stenting and nephrostomy tubes(3 months)
研究者
Ben Chew, MD
Associate Professor
University of British Columbia