Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 500
- 试验地点
- 4
- 主要终点
- Hours to First Antibiotic Modification
研究概览
简要总结
RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):
- Standard culture and antimicrobial susceptibility testing (AST); or
- Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
详细描述
RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):
- Standard culture and antimicrobial susceptibility testing (AST); or
- Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
Patient specimens with positive blood culture with Gram stain showing GNB identified during local laboratory business hours will be enrolled by the Microbiology Laboratory Technologist if they do not meet any exclusion criteria. Subject specimens will be randomized 1:1 to standard culture and AST or Rapid identification and AST using the FDA approved Accelerate Pheno TM System. Both groups will receive standard antimicrobial stewardship (AS). The primary service, including the prescribing provider, will be unaware of group assignment at the time of randomization, so initial antibiotic choice will not be affected by group assignment. Once rapid results become available and/or AS interventions are made, treating providers may become aware of group assignment.
The goal of this study is to determine the impact of rapid bacterial identification and phenotypic antimicrobial susceptibility testing (AST) on antimicrobial usage and clinical outcomes.
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
- Single (Care Provider)
盲法说明
Primary service/provider: The primary service, including the prescribing provider, will be unaware of group assignment at the time of randomization, so initial antibiotic choice will not be affected by group assignment. Once rapid results become available and/or AS interventions are made, treating providers may become aware of group assignment.
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.
排除标准
- •Identification of GNB outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
- •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 organism, gram-negative cocci, and/or yeast detected on Gram stain
- •Previous enrollment in this study
- •No Minnesota research authorization (Rochester site only)
结局指标
主要结局
Hours to First Antibiotic Modification
时间窗: 72 hours after randomization
Mean hours until first modification of antibiotic therapy within 72 hours post randomization
次要结局
- Time to First Antibiotic Escalation(Within 72 hours of randomization)
- Subjects Who Experienced Mortality Within 30 Days of Randomization(Within 30 days of randomization)
- Length of Stay in the Hospital(Within 30 days of randomization)
- ICU Status Through 72 Hours Post-randomization(Within 72 hours of randomization)
- Time to First Gram-negative Antibiotic Escalation(Within 72 hours of randomization)
- Time to First Gram-positive Antibiotic Escalation(Within 72 hours of randomization)
- Time to First Antibiotic De-escalation(Within 72 hours of randomization)
- Time to First Gram-positive Antibiotic De-escalation(Within 72 hours of randomization)
- Number of Hospital-onset Clostridium Difficile Infections(Within 30 days of randomization)
- Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.(Within 30 days of randomization)
- Time to First Gram-negative Antibiotic De-escalation(Within 72 hours of randomization)