A Prospective Anaylsis of Biofilm in Urinary Catheters Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 9
- 试验地点
- 1
- 主要终点
- To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.
研究概览
简要总结
To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter. A 30cc urine sample would also be collected from the same subject, and analyzed.
详细描述
After obtaining informed consent, concurrent with the changing of the Foley catheter in the clinic, would be obtaining a 30 cc. sample of urine which would also be fast frozen and stored in a -81 degree freezer until shipped to the Venter clinic on dry ice.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject must be 18 years of age.
- •Subject is attending weekly office visits at SW Wound Care Center as an out- patient.
- •Subject must have an indwelling Foley catheter.
- •Subject is informed about the trial, understands its nature of the study and provides written informed consent prior to study enrollment.
- •Subject is willing and able to comply with all specified care and visit requirements.
排除标准
- •Subject refuses to participate in the study.
- •Subject is expected to be non-compliant.
- •Subject is a resident in a nursing home, or institutionalized.
- •Subject is pregnant.
- •Subject has a Legally Authorized Representative
结局指标
主要结局
To analyze biofilm obtained from at least 10 Subjects who have an indwelling catheter.
时间窗: Over a period of 20 weeks
the proteomics, metabolomics and metagenomics ("omics") data will be analyzed and integrated in order to understand the microbial population dynamics and the interactions with the human subject host responses which may include antibacterial defenses, local inflammation, immune tolerance towards bacteria
次要结局
未报告次要终点