Efficacy of Bladder Catheters Lubricated With a Biofilm Disruptive Gel, in Reducing Catheter-associated Bacteriuria (CAB) Compared to Standard of Care: A PILOT Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 15
- 试验地点
- 2
- 主要终点
- Urine microorganisms DNA analysis
研究概览
简要总结
This is a 2-week, single-site, randomized study in adults requiring short-term (≤ 14 days) catheterization. Subjects will be randomized 1:1 to either the biofilm disrupting gel (BLASTX) or SOC (McKesson Jelly) lubricated catheters. Urine and/or catheter DNA analysis will be obtained at catheter insertion, 2, 5, 7 and 14 days after catheterization.
详细描述
This is a 2-week, single-site, randomized controlled pilot study in adults requiring short-term < 14 days catheterization. Subjects will be randomized 1:1 to either the BLASTX or SOC lubricated catheters.
Urine and catheter DNA analysis will be obtained at catheter insertion, 2 to 3 days after catheterization and at 5, 7 and 14 days if catheterization was indicated for either duration.
Informed consent discussion will be completed, ICF will be signed, prior to any study procedures.
Subjects will be included only if all of the inclusion criteria and none of the exclusion criteria have been met.
After randomization, subjects will be followed, urine samples will be collected at each scheduled visit and the catheters will be collected upon removal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
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
- •18 years or older
- •Absence of symptomatic UTI
- •Absence of upper/lower tract obstructions
- •No known allergies to the study products
- •Willing to comply with all study procedures and available for the duration of the study
排除标准
- •17 years or younger
- •Symptomatic UTI
- •Presence of upper/lower tract obstructions
- •Known allergic reaction to the study products
- •Unable to provide signed and dated informed consent form
结局指标
主要结局
Urine microorganisms DNA analysis
时间窗: Up to 14 days
Change in microorganisms in the test group compared to the control group.
Catheter microorganisms DNA analysis
时间窗: Up to 14 days
Change in microorganisms in the test group compared to the control group.
次要结局
- Incidence of Urinary Tract Infections (UTIs)(14 days)