Primary Investigation Into the Performance of the MicroPhage S. Aureus / MSSA / MRSA Test Direct From Blood Culture.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 712
- 试验地点
- 3
- 主要终点
- Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.
研究概览
简要总结
In-vitro identification of S. aureus, methicillin-sensitive S. aureus (MSSA), and methicillin-resistant S. aureus (MRSA) from positive blood cultures by MicroPhage's bacteriophage-based diagnostic platform.
详细描述
This is a multi-center, preclinical study to investigate the effectiveness of the performance of MicroPhage S. aureus / MSSA/MRSA test direct for blood culture. There will be no patient consent, as this is a laboratory performance study on leftover specimens. The MicroPhage test will be compared to site standards (gold standard) and market-available tests with similar indications (comparators). MicroPhage will require data to be collected at 4 hours and 5 hours following the start of the MicroPhage test. The study will last 2-3 months, depending on the accrual rate of the institution.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- •Over 18 years of age.
- •Blood culture positive, of ANY of the following bottle types:
- •BD Bactec Standard Aerobic and Anaerobic,
- •BD Bactec Plus Aerobic and Anaerobic,
- •bioMerieux BacT/Alert Standard Aerobic and Anaerobic,
- •bioMerieux BacT/Alert FAN Aerobic and Anaerobic.
排除标准
- •BD Bactec Lytic, Pediatric, or other bottle types not listed above.
- •bioMerieux Pediatric FAN or other bottle types listed above.
- •Trek bottles.
- •Specimens from patients under 18 years of age.
结局指标
主要结局
Determination of clinical performance of preliminary MicroPhage S. aureus/MSSA/MRSA test directly from clinical blood culture positives.
时间窗: Within 48 hours
次要结局
- Qualitative feedback on the preliminary MicroPhage test protocol.
- Comparative results to market-available S. aureus / MRSA tests for Blood Culture.(Within 48 hours)