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临床试验/NCT00126698
NCT00126698已完成4 期

Use of Antibiotic Prophylaxis on Urethral Catheter Withdrawal: A Randomized Double-Blind Placebo-Controlled Trial

St. Antonius Hospital2 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2005年1月1日最近更新:
适应症
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
100
试验地点
2
主要终点
Symptomatic bacteriuria

研究概览

简要总结

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The purpose of this study is to determine whether antibiotic prophylaxis for urinary catheter removal is useful at preventing catheter-associated urinary-tract infection.

详细描述

Urinary-tract infection (UTI) is the most common type of hospital-acquired infection (30% of all). The researchers undertake a double-blind, placebo-controlled trial to assess the efficacy of single-dose therapy of trimethoprim-sulfamethoxazole or ciprofloxacin, versus placebo therapy in selected groups of surgical patients who had bladder drainage scheduled to last longer than 3 days.

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

入排标准

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

入选标准

  • Urethral catheter in situ for at least 3 days (72h)

排除标准

  • Pregnancy
  • Impaired renal or hepatic function (serum creatinine > 150 mmol/l, serum transaminases > 75 IU/l)
  • Symptomatic urinary tract infection
  • Antibiotic use ≤ 48 hours before urinary catheter removal
  • Allergy to trimethoprim-sulfamethoxazole or ciprofloxacin
  • Urologic pathology

结局指标

主要结局

Symptomatic bacteriuria

Asymptomatic bacteriuria

次要结局

  • Antibiotic resistance patterns

研究者

申办方类型
Other

研究点 (2)

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