CTRI/2024/09/074256招募中1/2 期
Evaluation of efficacy and safety of ciprofloxacin impregnated catheters in preventing catheter associated urinary tract infections in patients requiring short-term catheterization-An open labelled clinical trial.
Krishna Parmar1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2024年10月4日最近更新:
试验速览
- 阶段
- 1/2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Incidence of catheter associated urinary tract infection in ciprofloxacin impregnated catheter
研究概览
简要总结
This is a randomized controlled open labelled clinical trial for evaluation of efficacy and safety of ciprofloxacin impregnated catheter in preventing catheter associatted urinary tract infection (CAUTI). Catheter will be impregnated in intravenous solution 200 mg in 100ml of ciprofloxacin and used in patients requiring short term catheterisation. Urine routine microscopy and culture will be done on day 3,7,10,21and28. Primary outcome is to compare incidence of CAUTI in ciprofloxacin impregnated foleys catheter and standard foleys catheter.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male or female patients of age of 18 years or above.
- •Patients who need an indwelling urinary catheter as a method of bladder drainage for at least 7 days.
- •3.Patients who are willing to participate in the study and give their written informed consent.
排除标准
- •1.Patients who can benefit from other method of bladder drainage such as intermittent catheterization, suprapubic drainage.
- •Patients with urinary tract infection at the time of admission.
- •3.Current antibiotic use or use within 7 days prior to inclusion based on past history.
- •Known allergy to latex, silver salts or hydrogels.
- •Patients with surgical interventions in the urinary tract that may interfere, at the investigator criteria, with the study results.
- •Pregnant or breastfeeding woman.
- •Pyschiatric patients
- •Patients with altered consciousness.
结局指标
主要结局
Incidence of catheter associated urinary tract infection in ciprofloxacin impregnated catheter
时间窗: 2 months
次要结局
- Incidence of Asymptomatic Urinary Tract infection in ciprofloxacin impregnated foleys catheter(2 months)
研究者
Dr Krishna Parmar
Shri Vasantrao Naik Government Medical College
研究点 (1)
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