Study of a Urethral Catheter Coated With Eluting Silver Salts
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 1,188
- 试验地点
- 2
- 主要终点
- Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
研究概览
简要总结
Urinary catheters are often needed in hospital patients, but their use can increase the chance that a catheter associated urinary tract infection (called a CAUTI) may occur. This study will try to determine if patients who get a new silver coated catheter will have slower to time to development of a CAUTI compared to patients who get an uncoated catheter.
详细描述
This study is a prospective, multicenter, randomized controlled pivotal study designed to compare the time to occurrence and incidence of CAUTI in subjects catheterized with a new hydrogel-silver salts latex catheter (test) to those of subjects catheterized with a silicone elastomer-coated latex catheter (control).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •male or female at least 18 years of age
- •life expectancy of 3 months or more
- •expected to require a urinary catheter for at least 48 hours
排除标准
- •recent urinary tract surgery or instrumentation
- •presence of a urinary tract device
- •concurrent genitourinary tract infection
- •recent indwelling urinary catheter
- •requires use of a non-study urinary catheter
结局指标
主要结局
Time to Occurrence of Bacteriuric Urinary Tract Infection (bUTI) in Subjects Catheterized for >= 48 Hours
时间窗: >=48 hours to 10 days
Time to occurrence of bUTI in subjects of both study groups who were catheterized with a study catheter for \>= 48 hours and who had evidence of bUTI after study catheter insertion. Subjects who did not have a bUTI are not included in the median calculation, so the median only includes data from non-censored observations.
次要结局
- Percentage of Participants With a bUTI After Catheterization for >= 48 Hours(>=48 hours to 10 days)
- Number of Participants With Bacteriuria at a Concentration of ≥ 10e3 < 10e5 CFU/mL(10 days)
- Time to Occurence of Symptomatic Urinary Tract Infection (sUTI) in Subjects Catheterized for >= 48 Hours(>= 48 hours to 10 days)
- Time to Occurance of sUTI in Subjects Catheterized for >= 24 Hours(>= 24 hours to 10 days)
- Time to Occurence of bUTI in Subjects Catheterized for >= 24 Hours(>= 24 hours to 10 days)