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临床试验/NCT01108757
NCT01108757终止不适用

Prevention of Catheter-Associated Urinary Tract Infections in Patients Undergoing Incontinence and Reconstructive Pelvic Surgery: A Randomized Controlled Trial

The Cleveland Clinic1 个研究点 分布在 1 个国家目标入组 52 人开始时间: 2010年4月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
不适用
状态
终止
入组人数
52
试验地点
1
主要终点
Number of Participants With Urinary Tract Infection

研究概览

简要总结

The study will assess the risk of catheter associated urinary tract infection in women undergoing incontinence or reconstructive pelvic surgery. Women will be given an antibiotic or placebo at the time of catheter removal. The investigators hypothesize that prophylactic antibiotics will reduce the rate of infection.

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
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
21 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Requires catheterization >24h hours following incontinence or pelvic reconstructive surgery

排除标准

  • Receipt of antibiotics for either prophylaxis or treatment of a known infection during the postoperative hospitalization
  • Allergy to sulfonamides or trimethoprim
  • Non-English speaking
  • Pregnancy
  • Breast feeding
  • Severe renal impairment (creatinine clearance <30)
  • Patients taking dofetilide, methenamine, procaine, warfarin, procainamide, methotrexate.

研究组 & 干预措施

Drug

Experimental

干预措施: Bactrim (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Other)

结局指标

主要结局

Number of Participants With Urinary Tract Infection

时间窗: 7 days following catheter removal

Urinary tract infection diagnosis was obtained after confirmation with urine culture microbiology report. Infection was defined as \>100,000 colony forming units/mL

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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