Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- We anticipate that patients whose blood cultures are characterized using DISK will have faster time to effective antibiotic therapy and better clinical outcomes than patients whose blood cultures are characterized using standard of care methods.
研究概览
简要总结
Background: Rapid antimicrobial susceptibility testing (AST) of Gram negative bacilli (GNB) from blood culture bottles may lead to earlier “pathogen-directed†antimicrobial therapy, better patient outcomes, and less antimicrobial resistance, compared to conventional testing.
Objective: To evaluate the clinical impact of a rapid method for direct phenotypic AST of GNB from positive blood cultures versus Standard of Care (SOC), both implemented with antimicrobial stewardship team oversight. The rapid testing method involves disk diffusion AST direct from positive blood culture bottles, read between 8-10 hours of incubation.
Design: This study is a 2-arm multinational prospective randomized controlled clinical trial. Hospitalized subjects with Gram-negative bacilli in blood cultures will be randomized to have blood cultures characterized using SOC vs. the rapid testing method in addition to SOC
Outcomes: We will compare clinical outcomes and antimicrobial utilization between the arms.
Subjects and timeline: 1000 subjects in 10 sites across 6 countries over approximately 2 years. Enrollment start date: September 2021.
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified randomization
- 盲法
- Outcome Assessor Blinded
入排标准
- 年龄范围
- 1.00 Day(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.
排除标准
- •Positive blood culture for GNB at the same institution within prior 7 days (if known at the time of randomization), Deceased at the time of randomization, GNB plus Gram-positive bacterium, Gram-negative coccus, and/or yeast detected on Gram stain •Previous enrollment in this study •Not hospitalized.
结局指标
主要结局
We anticipate that patients whose blood cultures are characterized using DISK will have faster time to effective antibiotic therapy and better clinical outcomes than patients whose blood cultures are characterized using standard of care methods.
时间窗: one week of admission, date of discharge OR upto 30 days of hospitalisation
次要结局
- We anticipate that patients whose blood cultures are characterized using DISK will have better antibiotic utilization and lesser irrational antibiotic therapy than patients whose blood cultures are characterized using standard of care methods.(one week of admission, date of discharge OR upto 30 days of hospitalisation)