Single-Dose Versus 3-Day Cotrimoxazole Prophylaxis in Transurethral Resection or Greenlight Laser Vaporisation of the Prostate: A Pragmatic, Multicentre Randomised Placebo Controlled Non-Inferiority Trial
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 728
- 试验地点
- 5
- 主要终点
- Symptomatic UrinaryTract Infection (UTI)
研究概览
简要总结
The optimal duration of antimicrobial prophylaxis (study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole)) in transurethral resection of the prostate and Greenlight Laser vaporisation of the prostate is investigated by comparing a guideline-conform single-dose prophylaxis (intervention) versus usual clinical care (i.e. 3-day prophylaxis; control) for prevention of urinary tract infections.
详细描述
Increasing antimicrobial resistance rates have a substantial impact on morbidity, mortality and healthcare costs and is particularly prevalent among urological patients due to an overuse of antimicrobial agents for therapeutical and prophylactic indications. Transurethral resection of the prostate is one of the most frequently performed urological procedures in Switzerland and a single-dose of antimicrobial prophylaxis is recommended to reduce postoperative urinary tract infections. For photoselective vaporisation of the prostate with the Greenlight Laser, a similar operative alternative, there are currently no international guidelines for antimicrobial prophylaxis.
The optimal duration of antimicrobial prophylaxis in transurethral resection of the prostate and Greenlight Laser vaporisation of the prostate is investigated by comparing a guideline-conform single-dose prophylaxis (intervention) versus usual clinical care (i.e. 3-day prophylaxis; control) for prevention of urinary tract infections.
The study medication Cotrimoxazole (Trimethoprim/Sulfamethoxazole) is a routinely used antimicrobial substance recommended in international and in-house guidelines for antimicrobial prophylaxis and treatment of urinary tract infections. Perioperative antimicrobial prophylaxis will be Cotrimoxazole short infusion in both groups. Postoperative study medication packages consists of either five tablets of placebo or five tablets of Cotrimoxazole (Nopil forte®) 800/160mg using licensed product repacked in a new immediate container which is blinded
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Obstructive voiding disorder (e.g. benign prostate hyperplasia, obstructive prostate cancer)
- •Planned Transurethral resection of the prostate (TURP) or Greenlight Laser (GL)
排除标准
- •Evidence for (catheter associated-) UTI, with or without antibiotic treatment in the last 7 days prior to randomisation.
- •Any evidence of a history of positive urine culture (cfu ³105/ml in midstream-urine with no more than two species) and resistance to TMP/SMX in the last 7 days prior to randomisation.
- •Known contraindication against study drugs according to the Swissmedic package leaflet (e.g. known liver dysfunction, renal insufficiency; patients with glomerular filtration rate (calculated by the Modification of Diet in Renal Disease (MDRD) or Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) <30ml/min or dialysis patients will be excluded).
- •Antibiotic treatment for any reason within 7 days prior to randomisation
- •Indication for Antibiotic prophylaxis (AP) for other reasons (e.g. endocarditis prophylaxis, transplanted patients under systemic immunosuppression).
研究组 & 干预措施
Group A
Single-dose Trimethoprim (TMP)/sulfamethoxazole (SMX, i.e. Cotrimoxazole) perioperative as two ampoules of TMP/SMX 400/80 mg (Bactrim Inf Konz®) solved in 250 ml sodium chloride short infusion followed by five oral applications of placebo (lactose tablet; Fagron Gesellschaft mit beschränkter Haftung (GmbH) & Co.KG) at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.
干预措施: oral applications of Placebo (Drug)
Group B
3-day application with TMP/SMX (i.e. Cotrimoxazole): Preoperatively as two ampoules of TMP/SMX 400/80mg (Bactrim Inf Konz®) solved in 250 ml sodium chloride short infusion, followed by five oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) at the evening of the surgery and thereafter twice daily on day 1 and 2 after surgery while the patient is in hospital.
干预措施: oral applications of TMP/SMX 800/160 mg (Nopil forte® tablets) (Drug)
结局指标
主要结局
Symptomatic UrinaryTract Infection (UTI)
时间窗: within 30 days after randomization
Symptomatic UTI (based on clinical diagnosis) treated with antimicrobial agents
次要结局
- Symptomatic UTI by measured bacteriuria(within 30 days after randomization)
- Symptomatic cystitis (based on clinical diagnosis)(within 30 days after randomization)
- Symptomatic epididymitis (based on clinical diagnosis)(within 30 days after randomization)
- Symptomatic pyelonephritis (based on clinical diagnosis)(within 30 days after randomization)
- Symptomatic urethritis (based on clinical diagnosis)(within 30 days after randomization)
- Urosepsis (based on clinical diagnosis)(within 30 days after randomization)
- Prescribed defined daily doses (DDD) of antibiotics (cumulative sum of DDD) day 30)(within 30 days after randomization)
- Asymptomatic bacteriuria of ≥105 cfu/ml treated with antimicrobial agents(within 30 days after randomization)
- Symptomatic prostatitis (based on clinical diagnosis)(within 30 days after randomization)
- Detection of multidrug-resistant bacteria in Urine culture(within 30 days after randomization)
- Prescription of antibiotics (for any reason)(within 30 days after randomization)
- Any Clostridium difficile-associated infection(within 30 days after randomization)
- Duration of catheterisation (cumulative sum of days between randomisation and end of catheterisation or day 30)(within 30 days after randomization)
- Duration of hospital stay (cumulative sum of Hospital days between randomisation and day 30)(within 30 days after randomization)
- Re-hospitalisation (within 30 days after randomisation)(within 30 days after randomization)
- Total serious adverse events(within 30 days after randomization)
- Duration of intensive care unit (ICU) stay (cumulative sum of ICU days between randomisation and day 30)(within 30 days after randomization)
- Change of Quality of life Score (prior to randomisation and at day 30 after randomisation)(within 30 days after randomization)
- All-cause mortality(within 30 days after randomization)
- Total adverse events(within 30 days after randomization)
- Change of International Prostate Symptom Score (prior to randomisation and at day 30 after randomisation)(within 30 days after randomization)