A Multi-Center Protocol for Obtaining and Storing Human Samples for Immediate or Future Microbial, Immune,or Host-Microbe Scientific Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 1
- 主要终点
- The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques.
研究概览
简要总结
The intent of this protocol is to salvage human-related material that is normally destined for destruction, so it can be used in infection-related scientific studies. This clinical material can be studied in order to better understand the molecular, cellular, or ecological components of the infected or potentially infected tissue or device.
详细描述
The samples can include material such as wound debridement, removed orthopedic implants, removed catheters or shunts, excised tonsils, amputated tissue, sputum, stool, or other excretions. The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques. The studies can examine microbes or the host's response to microbes by examining the nucleic acids (e.g. 16S DNA, mRNA), proteins, or other metabolites.
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
- •The Subject must be 18 years of age or older
- •The Subject must be mentally competent as determined by the Investigator, or have a Legally Authorized Representative.
排除标准
- •The Subject may not be currently incarcerated.
- •The Subject may not be knowingly pregnant.
- •The Subject may not be institutionalized.
- •The Subject may not be an employee or student of the investigator or sponsor.
结局指标
主要结局
The samples can be cultured for microbes, examined using microscopy, or analyzed using molecular techniques.
时间窗: 1 year
次要结局
未报告次要终点
研究者
Randall Wolcott
Prinicipal Investigator
Southwest Regional Wound Care Center
