Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles - A Quality Improvement Theragnostic Stewardship Project
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Mayo Clinic
- 入组人数
- 743
- 试验地点
- 2
- 主要终点
- Duration of Antimicrobial Therapy (Hours)
研究概览
简要总结
Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to increased cost)?
详细描述
We hypothesize that the FilmArray Blood Culture ID Panel will reduce the duration of empiric broad-spectrum antimicrobial therapy typically administered in patients who have positive blood cultures, improving clinical outcome and reducing cost. To test this hypothesis we propose a prospective, randomized controlled study comparing outcomes among patients with positive blood cultures who receive either: Standard culture and antimicrobial susceptibility testing (AST) of positive blood culture bottles as is done today (control), standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel (intervention group 1), or standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel testing along with expert infectious diseases phone consultation (intervention group 2). In both intervention groups, results of the FilmArray test will be communicated by phone to the primary service, along with templated comments about optimal antimicrobial therapy, based on the result. (Templated comments will also be used in the control group). In intervention group 2, an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy, if appropriate, based on microbiology results and clinical information obtained through medical record review and discussion with the primary service.
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 (Participant)
入排标准
- 年龄范围
- — 至 99 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Duration of Antimicrobial Therapy (Hours)
时间窗: Approximately 4 days after enrollment
Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.
次要结局
- Time From Positive Gram Stain to First Active Antibiotic(Approximately 14 days after positive blood culture)
- Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics(Positive Gram stain, 96 hours after enrollment)
- Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours(Within 14 days after positive blood culture)
- Time to Pathogen Identification(Approximately 14 days after positive blood culture)
- Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment(3 Days after enrollment)
- Length of Entire Hospitalization (Days)(Participants were followed for the duration of hospital stay, approximately 15 days)
- All-cause and Attributable Mortality(30 days after positive blood culture)
- Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events(Approximately 14 days after positive blood culture)
- Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment(Approximately within 72 hours of positive blood culture)
- Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject(Approximately 7 days after positive blood culture and for duration of entire hospitalization)