Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 899
- 试验地点
- 10
- 主要终点
- Subject Clinical Outcomes, as measured by Desirability of Outcome Ranking (DOOR)
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 Reveal™ 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
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
盲法说明
Patient and care provider will not know which arm subject is randomized into until after the stewardship team has review the Reveal results and provided feedback on initial therapies prescribed.
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.
- •Hospitalized at the time of Gram stain result.
- •Enrolled within 16 hours of blood culture positivity.
排除标准
- •Positive blood culture for GNB 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.
研究组 & 干预措施
Reveal
When a blood culture growing GNB is randomized to the Reveal arm, the positive blood culture will be characterized using Reveal, a rapid AST, and the standard of care AST.
干预措施: Reveal (Diagnostic Test)
Standard of Care
When a blood culture growing GNB is randomized standard of care arm the positive blood cultures will be characterized using standard of care antimicrobial susceptibility testing (AST)
结局指标
主要结局
Subject Clinical Outcomes, as measured by Desirability of Outcome Ranking (DOOR)
时间窗: Up to 30 days after Gram stain result
The composite 3-category DOOR outcome will assess three deleterious events (unsuccessful discharge, lack of clinical response, and undesirable events) in addition to survival up to 30 days after Gram stain result. The primary DOOR outcome measure is defined using three ordered levels. From best to worst, they are: 1. Alive without deleterious events 2. Alive with at least 1 deleterious event 3. Death
Participant Clinical Outcomes, as Measured by Desirability of Outcome Ranking (DOOR)
时间窗: Up to 30 days after Gram stain result
The composite 3-category DOOR outcome will assess three deleterious events (unsuccessful discharge, lack of clinical response, and undesirable events) in addition to survival up to 30 days after Gram stain result. The primary DOOR outcome measure is defined using three ordered levels. From best to worst, they are: 1. Alive without deleterious events 2. Alive with at least 1 deleterious event 3. Death
次要结局
- Time to antibiotic escalation(within 3 days from Gram stain result)
- Hospital Stay Length(up to 30 days post Gram stain result)
- Number of participants with new Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. difficile(up to 30 days post Gram stain result)
- Time to effective antibiotic therapy(within 3 days from Gram stain result)
- Time to antibiotic de-escalation of Gram negative coverage(within 3 days from Gram stain result)
- All-Cause Mortality(Up to 30 days post Gram Stain)
- Number of ICU admissions(up to 30 days post Gram stain result)
- Number of Participants With All-Cause Mortality(Up to 30 days post Gram Stain)
- Number of Participants With ICU Admissions(up to 30 days post Gram stain result)
- Number of Participants With New Acquisition of Multi-Drug Resistant Organism (MDRO) and/or C. Difficile(up to 30 days post Gram stain result)
- Number of Participants With New Multidrug-Resistant Organism (MDRO)(up to 30 days post Gram stain result)
- Number of Participants With C. Difficile(up to 30 days post Gram stain result)
- Number of Participants With MRSA(up to 30 days post Gram stain result)
- Number of Participants With VRE(up to 30 days post Gram stain result)
- Number of Participants With CTX Resistant Enterobacterales(up to 30 days post Gram stain result)
- Number of Participants With CRE(up to 30 days post Gram stain result)
- Number of Participants With MDR Pseudomonas(up to 30 days post Gram stain result)
- Number of Participants With CRAb(up to 30 days post Gram stain result)
- Number of Participants With Candida Auris(up to 30 days post Gram stain result)
- Time to Effective Antibiotic Therapy(within 3 days from Gram stain result)
- Receiving Effective Antibiotic Therapy Within 24 Hours(within 24 hours from Gram stain result)
- Receiving Effective Antibiotic Therapy Within 3 Days(within 3 days from Gram stain result)
- Time to Antibiotic Escalation or De-escalation(within 3 days from Gram stain result)
- Antibiotic Change Within 3 Days(within 3 days from Gram stain result)