NCT00670215已完成3 期
Prospective, Randomized, Double-blind, Comparison of Ciprofloxacin Extended-release 1000 mg Tablets Given as Two Different Prophylactic Dosing Regimens (Regimen I - Single-dose Ciprofloxacin MR 1000 mg or Regimen II - Multiple-dose Ciprofloxacin MR 1000 mg Once Daily for 3 Days) for the Prevention of Post-operative Infectious Complications in Patients Undergoing Transrectal Needle Biopsy of the Prostate
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Bayer
- 入组人数
- 497
- 主要终点
- Bacteriological Response (bacteriuria vs. no bacteriuria)
研究概览
简要总结
The primary purpose of this clinical trial is to compare in a double-blind randomized trial, the efficacy and safety of ciprofloxacin MR 1000 mg tablets given as a single-dose or as a multiple-dose regimen for the prevention of infectious complications in patients undergoing transrectal needle biopsies of the prostate (TRNBP).
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
- Male
- 接受健康志愿者
- 否
入选标准
- •Transrectal needle biopsy of the prostate required.
- •A clean-catch midstream-urine (MSU) culture negative (<104 CFU/mL) for possible pathogens at the Pre-Therapy Visit prior to the TRNBP.
- •Gastrointestinal absorption is adequate as evidenced by passage of gas or feces per rectum and patient can tolerate oral food, fluids, and medication without vomiting or diarrhea.
排除标准
- •History of hypersensitivity to ciprofloxacin or other quinolone antibiotics
- •Valvular heart disease that requires antibiotic prophylaxis to prevent bacterial endocarditis
- •Concomitant use of theophylline, probenecid, or warfarin at any time during the entire study
- •Renal insufficiency
- •Known or suspected central nervous system disorder that may predispose to seizures or lower the seizure threshold
- •Absolute neutrophil count (ANC) <1000/mm3
- •Human immunodeficiency virus (HIV) infection with a CD4 count <200 cells/micL. HIV testing is NOT required
- •Antibiotic administration within one week of the TRNBP
- •Severe hepatic insufficiency (Child-Pugh C)
研究组 & 干预措施
Arm 1
Experimental
干预措施: Ciprofloxacin single dose (Drug)
Arm 2
Experimental
干预措施: Ciprofloxacin triple dose (Drug)
结局指标
主要结局
Bacteriological Response (bacteriuria vs. no bacteriuria)
时间窗: 10-14 days after last dose of study med
次要结局
- Clinical Response (patients without clinical symptoms or signs of bacteriuria vs. patients with clinical symptoms or signs of bacteriuria)(10-14 days after last dose of study med.)
- Incidence of post-procedure GU tract infections other than bacteriuria(any time after the TRNBP)
研究者
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