Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System With New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 731
- 试验地点
- 3
- 主要终点
- Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method
研究概览
简要总结
This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.
详细描述
This clinical study entitled "Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens" is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017.
Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens.
The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB).
It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system
- •Positive blood culture sample containing gram-negative rods according to Gram stain results
- •For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded
- •A minimum sample volume of 2.0 mL
- •Seeded blood culture specimens derived from archived bacterial
排除标准
- •Blood culture positivity is > 8 hours prior to initiation of testing with the Accelerate Pheno™ system
- •Insufficient (less than 2.0 mL) remnant sample volume
- •From a patient that has already been enrolled in the study
- •Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media
- •Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity
结局指标
主要结局
Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method
时间窗: Approximately 4 months
次要结局
- Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results(Approximately 2 months)