A Multicenter 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
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,732
- 试验地点
- 10
- 主要终点
- Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis
研究概览
简要总结
This is a two arm, double blind RCT comparing the use of a single dose ciprofloxacin prior to SWL to saline alone. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.
详细描述
This is a two arm, double blind randomized controlled trial (RCT) comparing the use of a single dose ciprofloxacin prior to shock wave lithotripsy (SWL) to placebo. The multicenter trial will be conducted with a pragmatic emphasis including both high volume and low volume sites internationally.
Eligibility criteria include patients older than 18 years presenting for SWL who do not meet one of the pre-defined exclusion criteria (outlined below).
Eligible patients will provide written informed consent. Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.
Patients will undergo SWL using standard procedures at the participating center. Participants will asked to provide a pre-procedure study questionnaire, a modified International Prostate Symptom Score (IPSS) questionnaire and a urine sample for analysis prior to SWL and follow-up. Follow-up questionnaires and a requisition for urine culture will be provided in a pre-stamped, self-addressed envelope along with instructions to return both culture and questionnaires to their participating center at 7-14 days post-SWL. If the follow-up questionnaire has not been received by post-operative day 10 patients will receive a reminder phone call. A second envelope will be sent containing a requisition for urine culture and follow-up questionnaire when necessary.
Alternatively, if a 2 week follow-up is conducted at the participating site then data-forms can be completed and collected at that time. In the event that a urine culture was not submitted 7 days post-operatively, one can be collected up to 14 days post-op. Additional clinical parameters such as presence of double J, stone characteristics and renal insufficiency will be recorded at the time of SWL by the dedicated research staff at the participating center. Data acquisition and occurrence of outcomes will be monitored continuously with scheduled audits.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Patients will undergo central randomization, which will be accessed by phone or internet. Un-blinding will occur only once statistical analysis is complete.
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 older than 18 years presenting for SWL who do not meet one of the pre-defined exclusion criteria.
排除标准
- •Pre-SWL urine analysis positive for nitrites
- •Pre-SWL urine culture reveals >10e5 Colony Forming Unit/ml of bacteria (positive urine culture)
- •Taking antibiotics for Urinary Tract Infection (UTI) or other cause
- •Suspected struvite stone (based on previous stone analysis, or partial staghorn)
- •Presence of nephrostomy tube
- •Requiring cystoscopy and ureteral stent insertion on the day of SWL
- •Presence of Foley catheter or patient on regular clean intermittent catheterization (CIC)
- •Presence of urinary diversion (ie: ileal conduit)
- •History of urosepsis prior to SWL
- •Known allergic reaction to trial antibiotic
- •Previous randomization in this trial
- •In the opinion of the independent treating urologist, it is not in the patient's best interest to participate
研究组 & 干预措施
ciprofloxacin
Single dose oral or intravenous ciprofloxacin prior to shockwave lithotripsy
干预措施: Ciprofloxacin (Drug)
Placebo
identical oral placebo if oral cipro was used, or intravenous saline alone in a blinded fashion if IV cipro was used prior to shockwave lithotripsy.
干预措施: Placebo (Drug)
结局指标
主要结局
Composite outcome including positive urine culture, symptoms of cystitis, pyelonephritis or urosepsis
时间窗: 7-14 days post-shockwave lithotripsy
The composite outcome with be assessed as a dichotomous variable. The presence of Positive post-SWL urine culture (≥ 10e5 Colony Forming Unit/ ml), with either one or more of 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) will be considered as an event.
次要结局
- Pyelonephritis or urosepsis defined as Hospital admission with fever ≥38.5 Celsius(7-14 days post-shockwave lithotripsy)
- Bacteriuria defined as ≥ 100000 Colony Forming Unit/ml(7-14 days post-shockwave lithotripsy)
- Change in International Prostate Symptom Score (IPSS) total score (0-35, higher score indicates worse outcome)(14 days post-shockwave lithotripsy)
- Individual components of International Prostate Symptom Score (0-7 per domain, with higher score indicating worse outcome)(14 days post-shockwave lithotripsy)
- Symptoms of cystitis defined as new onset burning sensation or pain with voiding, frequency, urgency(7-14 days post-shockwave lithotripsy)
- Pain scale determined on a range of 0-5 with higher score indicating worse outcome(14 days post-shockwave lithotripsy)
研究者
Kari Tikkinen
Professor of Urology
Clinical Urology and Epidemiology Working Group