Prospective Study Into the Performance of the MicroPhage S. Aureus/MSSA/MRSA Test Direct From Blood Culture Positives
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,165
- 主要终点
- Determination of the performance of the MicroPhage S. aureus/ MSSA/MRSA Test for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives against gold standard laboratory tests.
研究概览
简要总结
Direct 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, two gold-standard reference methods, and two predicate devices with similar indications for use.
详细描述
This is a multi-center, FDA clinical study designed to investigate the safety and performance of the MicroPhage S. aureus/MSSA/MRSA test direct from blood culture positives. Informed consent is not anticipated, as this is a laboratory performance study with no patient intervention. The MicroPhage Test will be compared to site standards of care, market-available rapid tests, two predicate tests, and two disk diffusion tests for antimicrobial susceptibility. The study will last approximately 4-6 months (Bactec), dependent on the accrual rate of each institution.
This study is designed to support the following product indications for use:
The MicroPhage S. aureus/MSSA/MRSA Blood Culture Test is a qualitative in vitro diagnostic test for the rapid identification of Staphylococcus aureus and determination of methicillin susceptibility (MSSA) or methicillin resistance (MRSA) directly from positive blood cultures.
The test uses bacteriophage amplification to rapidly and phenotypically identify the presence of S. aureus and assess the response of the target organism to cefoxitin as an analog to methicillin.
This test is performed on positive blood cultures.
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
- •Blood culture positive samples from subjects aged 18+, with any of the following bottle types:
- •BD Bactec Standard Aerobic and Anaerobic,
- •BD Bactec Plus Aerobic and Anaerobic,
- •Completion of the MicroPhage test protocol on the sample.
排除标准
- •Samples from subjects under 18 years of age,
- •Samples from any other not included bottle types,
- •Samples from blood culture positives over 24 hours from alarm,
- •Samples deemed contaminated,
- •Mislabeled / misidentified samples or data without documented corrections,
- •Violations and/or deviations from the MicroPhage test protocol and/or other included test protocols under study.
结局指标
主要结局
Determination of the performance of the MicroPhage S. aureus/ MSSA/MRSA Test for identification of S. aureus and determination of MRSA and MSSA direct from clinical blood culture positives against gold standard laboratory tests.
时间窗: Daily per device protocol
ii) Comparison of the MicroPhage S. aureus/MSSA/MRSA test for identification of S. aureus and determination of MRSA to the gold Standard for MRSA (S. aureus gold standard and \</=10mm OXA DD or \</=21mm CFX DD) iii) Comparison of the MicroPhage S. aureus/MSSA/MRSA test for identification of S. aureus and determination of MSSA to the gold Standard for MSSA (S. aureus gold standard and \>/=13mm OXA DD or \>/=22mm CFX DD)
Determination of comparative performance of the MicroPhage S. aureus/MRSA/MSSA Test to the Oxoid PBP2a for determination of MRSA.
时间窗: Daily per device protocol
Performance comparison of the two tests.
次要结局
- Determination of clinical performance of the MicroPhage S. aureus/MSSA/MRSA Test to monitor S. aureus/MSSA/MRSA bacteremia clinical blood culture positives with unique subjects.(Daily per device protocol)