Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 900
- 试验地点
- 1
- 主要终点
- The primary outcome measures of subject disposition and deleterious events will be collected in order to assess the DOOR outcome up to 30 days after Gram stain result. The primary DOOR outcome measure is defined using three ordered levels: From best to worse they are alive without deleterious events; alive with 1 deleterious event; death.
研究概览
简要总结
This study is a 2-arm, multicenter, multinational, prospective, randomized, controlled clinical trial. Hospitalized subjects with blood cultures growing Gram negative bacilli (GNB) will be randomized 1:1 to have the positive blood cultures characterized using standard of care (SOC) antimicrobial susceptibility testing (AST) vs. a rapid AST method known as RevealTM in addition to SOC AST. The purpose of the FAST trial is to evaluate whether use of a rapid phenotypic AST improves clinical outcomes compared to use of SOC AST methods in clinical settings with high resistance rates.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 1.00 Day(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Positive blood culture with Gram stain showing GNB Hospitalized at the time of Gram stain result.
排除标准
- •Positive blood culture for GNB at the same institution within the prior 7 days (if known at the time of Gram stain result) Deceased at the time of Gram stain result Gram-positive bacilli, Gram-positive cocci, Gram-negative cocci, yeast, fungi, or multiple morphologies of GNB detected on Gram stain of blood culture Previous enrollment in this study.
结局指标
主要结局
The primary outcome measures of subject disposition and deleterious events will be collected in order to assess the DOOR outcome up to 30 days after Gram stain result. The primary DOOR outcome measure is defined using three ordered levels: From best to worse they are alive without deleterious events; alive with 1 deleterious event; death.
时间窗: 30 days
次要结局
- All-cause in-hospital mortality up to 30 days post Gram stain result(30 days)
- Length of index stay in the hospital up to 30 days post Gram stain result, for those subjects alive at 30 days. Length of stay will be calculated as date of discharge minus date of Gram stain result.(30 days)
- ICU admission up to 30 days post Gram stain result(30 days)
- New acquisition of multidrug resistant organism and or or C. difficile after Gram stain result and up to 30 days post Gram stain result. New acquisition is defined as detection of MDRO or C. difficile in subjects who do not have preceding clinical or surveillance cultures with these organisms in the prior 3 months. MDRO will be identified on routine clinical or surveillance samples using local laboratory diagnostic procedures(30 days)
- Time to effective antibiotic therapy within 3 days from Gram stain result, defined as treatment with an antibiotic (or antibiotic class) to which the blood isolate is susceptible based on SOC AST.(3 days)
- Time to antibiotic escalation of Gram negative coverage in those who have antibiotic escalation within 3 days from Gram stain result.(Escalation: Changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral (PO) to intravenous (IV) route.)
- Time to antibiotic de-escalation of Gram negative coverage in those who have antibiotic de-escalation within 3 days from Gram stain result.(De-escalation: Changing to a narrower spectrum antibiotic cessation of one or more antibiotics, or changing from an IV to PO route of appropriate drug (i.e. IV to PO ciprofloxacin or levofloxacin).)