Antibiotic Prophylaxis for Transrectal Prostate Biopsy-Ciprofloxacin vs. Trimethoprim/Sulfamethoxazole
试验速览
- 阶段
- 2 期
- 入组人数
- 2,800
- 试验地点
- 5
- 主要终点
- Admitted to hospital due to infection
研究概览
简要总结
This study will examine if a single dose of Ciprofloxacin and Trimethoprim/Sulfamethoxazole are equivalent for prophylaxis immediately prior to prostate biopsy, when a patient has a suspected prostate cancer.
详细描述
Background: The number of prostate biopsies are estimated to approximately 1.000.000 each year I Europe1. The infection rates after transrectal prostate biopsy are increasing annually2. The most common antibiotic used for prophylaxis is Ciprofloxacin, however, Trimethoprim/Sulfamethoxazole is also a feasible alternative3.
Aim: To evaluate the best antibiotic prophylaxis prior to trans rectal prostate biopsy in low risk patients.
Outcome: Hospitalization for infection within 14 days from biopsy.
Method: By randomization of all eligible patients with low risk of infectious complications. Patient and treating physician is blinded to treatment allocation. By using the nationwide and full coverage national patient register (NPR), mandatory for inpatient care4. All patients can be identified by the Swedish personal identification number5. Both patients related baseline characteristics is gathered through register linkages. To validate the outcome variables, for all patients admitted to hospital within 14 days will be subject for chart review. Comparing all patients from the participating units, having a code specific to trans rectal biopsy, and comparing to the excluded patients as well as included patients, will make a separate exclusion analysis.
The standard operating procedure for randomization is that patients will fill a form and informed consent of participation prior to the planned biopsy. If no exclusion criteria are filled and informed consent obtained, patient will be randomized through a web based randomization program, where only date of biopsy, earlier prostate biopsy, number of biopsies, PSA and prostate size is collected. Other baseline variables will be obtained by cross linkage to the NPR and the National Prostate Cancer Registry. A randomization number is given to all patients at this stage and a key code is established at each participating unit containing every patient randomization number and subsequent personal identification number.
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)
入排标准
- 性别
- Male
- 接受健康志愿者
- 否
入选标准
- •Indication for trans rectal prostate biopsy (Physicians discretion)
- •Informed consent
排除标准
- •Diabetes Mellitus
- •Indwelling urinary catheter
- •Prior urinary infection (last 6 months)
- •Dipstick positive (Nitrites test)
- •Allergy to Ciprofloxacin or Trimethoprim/Sulfamethoxazole
- •Severe liver disease
- •Concomittant use of Tizanidine
- •Immunosuppression
研究组 & 干预措施
Ciprofloxacin
T. Ciprofloxacin 750mg, single dose immediately prior to prostate biopsy
干预措施: Ciprofloxacin (Drug)
Trimethoprim/Sulfamethoxazole
Trimethoprim/Sulfamethoxazole 160mg/800mg immediately prior to prostate biopsy
干预措施: Trimethoprim/Sulfamethoxazole (Drug)
结局指标
主要结局
Admitted to hospital due to infection
时间窗: 14 days
Admission to hospital within 14 days from biopsy
次要结局
- Any hospital admission(Within 14 days)
- Hospitalisation time(Within 14 days)
- Total doses of antibiotics filled(Within 30 days)
- Risk factors for infection(Within 30 days)
- Filled antibiotic prescription(Within 30 days)
- Positive urinary or blood culture(Within 30 days)
- Overall Mortality(Within 90 days)
- Bacteriological characteristics(Within 30 days)