A Multicenter, Randomized, Double-Blind, Efficacy Study of Auriclosene Irrigation Solution on Indwelling Urinary Catheter Patency
试验速览
- 阶段
- 2 期
- 入组人数
- 140
- 试验地点
- 17
- 主要终点
- Percent flow rate reduction of study catheters at time of removal
研究概览
简要总结
Long-term indwelling urinary catheters are associated with chronic recurrent urinary tract infections and blockage caused by crystalline biofilm accumulation (encrustation) of the catheter surfaces. When the urine and catheter are colonized by urease-producing bacteria such as Proteus mirabilis, encrustation of the catheter is likely to occur.
The use of a catheter irrigation solution that can prevent biofilm formation and encrustation leading to blockage may keep the catheter patent longer, resulting in fewer catheter changes, potentially lower incidence of UTIs and better patient quality of life.
Auriclosene is a non-antibiotic, fast-acting, broad-spectrum antimicrobial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including the urease-producing Proteus mirabilis.
Subjects will be randomized to either Auriclosene Irrigation Solution or Auriclosene Vehicle solution.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •Subject requiring an indwelling urinary catheter with a history of catheter blockage and/or encrustation
- •Screening within 30 days of randomization
排除标准
- •Systemic antibiotic use within 14 days of first treatment
- •Investigational drug or device within 30 days if enrollment
- •Current infection requiring treatment with systemic antibiotics
- •Pregnant or lactating female
研究组 & 干预措施
Auriclosene (AIS)
Auriclosene Irrigation Solution, 0.2%, 8 treatments over 4 weeks
干预措施: Auriclosene Irrigation Solution, 0.2% (Drug)
Auriclosene Vehicle Solution
Auriclosene Vehicle Solution, 8 treatments over 4 weeks
干预措施: Auriclosene Vehicle Solution (Drug)
结局指标
主要结局
Percent flow rate reduction of study catheters at time of removal
时间窗: Up to 29 Days
次要结局
- Number of study catheters removed due to clinical catheter blockage(Up to 29 days)
- Number of subjects with serious and non-serious adverse events(Up to 29 Days)