Randomized Trial of Fast Bacterial Identification and Phenotypic Antimicrobial Susceptibility Testing in Patients With Positive Blood Cultures Using the Accelerate PhenoTest™ BC Kit, Performed on the Accelerate Pheno™ System as Compared With the Verigene® BC-GP/GN
试验速览
- 阶段
- 不适用
- 入组人数
- 774
- 试验地点
- 2
- 主要终点
- Duration of anti-pseudomonal β-lactam therapy
研究概览
简要总结
This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Patients will be randomized to one of the following FDA-cleared devices that will be used to assess the workflow impact of fast identification (ID) and antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients: 1) Standard culture and AST of positive blood culture bottles plus the Verigene® Blood Culture Gram-positive/Gram-negative kit (BC-GP/GN); or 2) Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
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
- •All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours
- •All adult (≥18 years of age)
排除标准
- •Identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
- •Positive blood culture in the prior week with same Gram stain result
- •Transferred from an outside hospital and had a history of a previously positive blood culture of the same Gram stain result
- •Previously enrolled in the study
- •Only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
- •Died or were transitioned to comfort care within 24 hours of enrollment
- •Negative Gram-stain
- •Not admitted to hospital for ≥ 24 hours following blood culture positivity
结局指标
主要结局
Duration of anti-pseudomonal β-lactam therapy
时间窗: 4 days after randomization
Mean duration of anti-pseudomonal β-lactam therapy
Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy
时间窗: 4 days after randomization
Mean duration of MRSA therapy
次要结局
未报告次要终点