NCT00406549已完成不适用
Multi-Center Clinical Performance Evaluation of a Rapid In Vitro Diagnostic Device for Direct Detection of Staphylococcus Aureus Nasal Colonization: Comparative Analysis to Culture Screening Methods
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,000
- 试验地点
- 11
研究概览
简要总结
To establish the clinical test performance characteristics of sensitivity, specificity and predictive values for direct detection of nasal Staphylococcus aureus colonization against clinical microbiology laboratory culture methods.
研究设计
- 研究类型
- Observational
- 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
- 否
入选标准
- •Subjects 18 years of age or older, male or female and from any race or culture.
- •Subjects who are ambulatory (able to walk unaided or with a cane, walker, wheelchair) on the day of their pre-operative visit for non-emergent surgery.
排除标准
- •Subjects who are on the nasal topical antibiotic Mupirocin (Bactroban® Nasal Ointment) within the last 4 weeks.
- •Subjects who are present at the preoperative visit with prescribed nasal medical devices (e.g. CPAP = Continuous Positive Airway Pressure or Nasal Cannula), nasal prosthetics, the wearing of nasal jewelry or trauma to the nose or anything that may inhibit sampling of the anterior nares.
研究者
研究点 (11)
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