Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Due to Gram-Negative Rods
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 主要终点
- Desirability of Outcome Ranking (DOOR) - composite outcome
研究概览
简要总结
The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.
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
- •Adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on Gram stain)
- •Blood culture drawn in the Emergency Department (ED)
排除标准
- •Patients not admitted to hospital
- •Patients discharged from hospital prior to blood culture positivity
- •Only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
- •Positive blood culture with GNR in the prior 7 days (if known at the time of randomization)
- •Transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization)
- •GNR plus gram-positive organism, gram-negative cocci, and/or yeast detected on blood culture Gram stain
- •Deceased or palliative care at the time of randomization
- •Patient who is moribund (does not survive the initial 72 hours after enrollment)
研究组 & 干预措施
Pheno
干预措施: Accelerate Pheno (Diagnostic Test)
Standard of Care
干预措施: Standard of Care (Diagnostic Test)
结局指标
主要结局
Desirability of Outcome Ranking (DOOR) - composite outcome
时间窗: 30 days
The primary endpoint is the probability that a patient will have a better DOOR when the Accelerate PhenoTest™ BC kit is used on positive blood cultures due to gram-negative rods compared to the standard of care
次要结局
未报告次要终点