Prospective Study Into the Performance of the KeyPathtm MRSA/MSSA Blood Culture Test - BTA
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 764
- 试验地点
- 3
- 主要终点
- Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA
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 culture using MicroPhage's bacteriophage-based diagnostic platform.
详细描述
This is a multi-center clinical study to investigate the effectiveness of the performance of the KeyPath MRSA/MSSA Blood Culture Test - BTA. The KeyPath test is performed directly on positive blood culture specimens from bioMerieux BacT/ALERT blood culture bottles. The MicroPhage test will be compared to standards and market available tests with similar indications (comparators). It is estimated that the study will last 3-4 months depending on the accural rate at the institutions.
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
- •Blood culture samples determined to be Gram-positive from subjects aged 18+, inclusive, with any of the following bottle types:
- •bioMerieux BacT/ALERT® Standard Aerobic and Anaerobic
- •bioMerieux BacT/ALERT® FAN Aerobic and FAN Anaerobic
- •Completion of the KeyPathTM BTA Test on the sample.
- •Completion of the reference method for S. aureus identification (tube coagulase and Remel Staphaurex ) and completion of the reference method for methicillin resistance determination (30 µg cefoxitin disc diffusion) for S. aureus positive samples.
排除标准
- •Samples from blood culture positives over 24 hours from alarm
- •Samples deemed contaminated.
- •Violations and/or deviations from the KeyPathTM BTA Test protocol and/or other included test protocols under study.
结局指标
主要结局
Prospective study into the performance of the KeyPath MRSA/MSSA Blood Culture Test -BTA
时间窗: 3-4 months
A. Determination of the performance of the KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives by: i. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for identification of S. aureus to the reference methods for S. aureus (tube coagulase and Staphaurex). ii. KeyPathTM MRSA/MSSA Blood Culture Test - BTA for determination of MRSA and MSSA among S. aureus positives by comparison to the reference method (30 µg cefoxitin disc diffusion).
次要结局
未报告次要终点