A Phase IIa Open Label Study to Evaluate the Safety and Antimicrobial Effects of NVC-422 on Bacteriuria in Chronically Catheterized Subjects
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Evaluate the safety and antimicrobial effect (and its duration) of NVC-422 in urine following bladder instillation in chronically catheterized subjects with bacteriuria
研究概览
简要总结
The purpose of this clinical trial is to study the effects of NVC-422 instilled into the bladder in reducing bacteria in the urine.
详细描述
Catheter-associated urinary tract infection (CAUTI) is a major healthcare problem in the U.S., accounting for approximately 40% of all hospital acquired infections. Microorganisms can colonize the catheter extraluminally or intraluminally, and are often protected in a biofilm environment. Nearly all patients catherized for 30 days or longer will develop bacteriuria, or the presence of bacteria in normally sterile urine. Ten to twenty percent of these patients will develop a symptomatic CAUTI. In a further 1-4%, the infection will spread into the kidneys or bloodstream, leading to potentially lethal bacteremia.
Currently, there is no bladder irrigation solution that can reduce or eliminate CAUTI. A bladder instillation solution that can keep the bladder and catheter substantially free of bacteria and biofilm is expected to provide a practical and cost-effective means of minimizing CAUTIs.
NVC-422 is a topical, non-antibiotic, fast acting, broad spectrum anti-microbial, which exhibits potential for the rapid decolonization of a range of urologic pathogens, including Escherichia Coli (E. coli), Enterococcus spp., P. mirabilis and others. In vitro studies with NVC-422 have also shown that it is capable of penetrating a biofilm and effectively killing the contained microbes.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •Patients or their guardians are willing and able to provide informed consent
- •Age > 18 years
- •Condition requiring chronic transurethral catheterization for at least 1 month prior to enrollment
- •Indwelling transurethral catheter not scheduled for exchange for at least 1 week from first treatment
- •Documented asymptomatic bacteriuria as defined in the protocol
- •Vital signs within the following limits: blood pressure 90 to 160 mm Hg systolic and 50 to100 mm Hg diastolic, pulse rate 45 to 100 bpm, respiratory rate 8 to 24 respirations per minute, oral body temperature 35.5ºC to 38.0ºC
- •Screening must occur within 14 days of enrollment into the study
排除标准
- •Unwillingness/inability to fulfill the requirements of the study
- •History of hepatitis B or C, HIV, AIDS, or other immunodeficiency disease
- •Systemic antibiotics within 7 days of enrollment
- •Any condition that, in the opinion of the principal investigator, would make the subject unsuitable for the study or place the subject at additional risk.
- •Any investigational drug or investigational device within 30 days of enrollment in the study
- •Women who are pregnant or lactating; or of child-bearing potential unless using highly effective birth control method for 1 month prior to and during the study
研究组 & 干预措施
Active
干预措施: sodium 2-(dichloroamino)-2-methylpropane-1-sulfonate monohydrate (Drug)
结局指标
主要结局
Evaluate the safety and antimicrobial effect (and its duration) of NVC-422 in urine following bladder instillation in chronically catheterized subjects with bacteriuria
时间窗: 7-10 days
次要结局
- Assess urine concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation(1-7 days)
- Assess plasma concentration of NVC-422 and its primary metabolite (2,2-DMT) following bladder instillation(1-7 days)