CTRI/2015/09/006220进行中（未招募）4 期
Evaluation of BIP Foley catheter in the prevention of catheter-associated urinary tract infections in Indian population (Clinical Phase IV Trial)
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 1,000
- 试验地点
- 6
- 主要终点
- Incidence of CAUTI according to CDC criteria (in % and No/1000 catheter days)
研究概览
简要总结
This is a prospective, randomized, multi-center, controlled, parallel group clinical phase IV study.
The study will include at least 3 evaluation points: patient inclusion into the study, patient assessment at catheter removal and patient assessment at follow up 2 days after catheter removal. The catheter will be removed according to clinical praxis (i.e. if it is no longer needed or when infection occurs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult patients (>18 years) Patients who are judged of need for indwelling urethral catheter (Foley catheter for at least 48 hours and up to 30 days).
排除标准
- •Patient treated with antibiotics for urinary tract infection (UTI) Patient receiving prophylactic antibiotics for catheterization Latex Allergy Patients with surgical interventions in the urinary tract that may interfere with the study results according to the investigator criteria Pregnant or breastfeeding women.
结局指标
主要结局
Incidence of CAUTI according to CDC criteria (in % and No/1000 catheter days)
时间窗: 30 days
次要结局
- •Antibiotic use for treatment of urinary tract infections 
(•Number of spontaneous urinary and blood cultures 
)
研究者
研究点 (6)
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