A Randomized Controlled Trial Assessing the Efficacy of Antimicrobial Prophylaxis for Extracorporeal Shock Wave Lithotripsy on Reducing Urinary Tract Infection
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 入组人数
- 360
- 试验地点
- 1
- 主要终点
- Impact of antibiotic prophylaxis on the rate of urinary tract infection
研究概览
简要总结
The purpose of this research study is to test whether administering one dose of an antibiotic before a routine shock wave lithotripsy procedure is more effective at avoiding any urinary infections compared to not taking an antibiotic. This is an important topic to study because urinary tract infections are one of the most common complications after this procedure and there is no clear standard of care regarding the use of pre-procedure antibiotics. Our study results will benefit future patients either by decreasing the rate of infections or decreasing the use of unnecessary antibiotics.
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
- Double (Participant, Investigator)
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
- •Scheduled for SWL at St. Joseph's Hospital;
- •18 years of age or older;
- •Willing and able to complete Questionnaires;
- •Willing to submit urine sample for analysis at Day 7;
- •Able to read and speak English.
排除标准
- •Pre-SWL urine analysis positive for nitrites or urine culture reveals >105 CFU/ml of bacteria (positive urine culture);
- •Taking antibiotics for UTI or other cause;
- •Requires an antibiotic post SWL;
- •Suspected struvite stone (based on previous stone analysis, or partial staghorn);
- •Presence of nephrostomy tube;
- •Requiring cystoscopy on the day of SWL;
- •Requiring ureteral stent on the day of SWL;
- •Presence of indwelling urinary catheter or on regular clean intermittent catheterization (CIC);
- •Presence of urinary diversion (ie: ileal conduit);
- •Any history of urosepsis;
- •Known allergic reaction to ciprofloxacin/quinolones;
- •Patient known to be pregnant;
- •Previous randomization in this trial;
- •In the opinion of the urologist, it is not in the patient's best interest to participate.
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Drug)
Ciprofloxacin
Ciprofloxacin
干预措施: Ciprofloxacin (Drug)
结局指标
主要结局
Impact of antibiotic prophylaxis on the rate of urinary tract infection
时间窗: Post SWL Day 7
Our primary outcome will be a composite endpoint comprised of: Positive post-SWL urine culture (≥ 105 colony forming units / millilitre (CFU/ml), symptoms of cystitis (defined as new onset burning sensation or pain with voiding, frequency, urgency), or pyelonephritis or urosepsis (hospital admission with fever ≥38.5 C).
次要结局
- Bacteriuria post-SWL (≥105 cfu/ml)(7-14 days)
- Symptoms of cystitis (new onset burning sensation or pain with voiding, frequency, urgency)(7-14 days)
- Pyelonephritis or urosepsis (hospital admission with fever ≥38.5C)(7-14 days)
- Change in Urinary Symptom Score(reported as positive or negative integer)(7 - 14 days)
研究者
Hassan Razvi
Principle Investigator
Lawson Health Research Institute