The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome: a Randomized Clinical Trial Within an Adaptive Platform Trial for Patients With Bloodstream Infections
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 400
- 试验地点
- 1
- 主要终点
- Compare commercially available R-AST testing tools with the current standard of care in BSI patients
研究概览
简要总结
The ACT-FAST study aims to compare commercially available Rapid Antimicrobial Susceptibility Testing (R-AST) tools with the current standard of care for patients with Bloodstream Infections (BSI). The primary objective is to evaluate whether "early targeted" antibiotic prescriptions, guided by these rapid tests, can improve antimicrobial stewardship and patient clinical outcomes.
To facilitate the evaluation of various diagnostic tools-including those currently on the market and those emerging in the near future-this study utilizes an adaptive clinical trial platform. This flexible design allows for the continuous assessment of different R-AST technologies within a single master protocol, ensuring that the most effective diagnostic strategies are identified efficiently.
详细描述
ACT-FAST is a multicenter, open-label, randomized, adaptive clinical trial designed as the first domain of a broader adaptive platform. The study evaluates the clinical and stewardship impact of "early targeted" antibiotic therapy guided by Rapid Antimicrobial Susceptibility Testing (R-AST) compared to standard empirical therapy in patients with suspected bloodstream infections (BSI).
The study population consists of patients with positive blood cultures for whom pathogen identification and susceptibility results are still pending. Participants are randomized into one of two diagnostic strategies:
- Experimental Arm: Blood cultures are processed using R-AST testing tools to provide rapid phenotypic or genotypic susceptibility data.
- Standard of Care (SoC) Arm: Blood cultures are processed according to the standard laboratory diagnostic workflow of the participating center.
In both arms, results are communicated to the treating clinicians, who adjust antibiotic therapy based on their clinical judgment and routine practice. As an adaptive trial, the randomization ratios may be adjusted based on the number of active intervention arms. To ensure scientific rigor, outcome assessors remain blinded to the treatment allocation.
Patients are followed for a total of 28 days to assess clinical outcomes and antimicrobial stewardship objectives. The platform design allows for the integration of additional R-AST tools or interventions through future protocol amendments, ensuring the study remains at the forefront of diagnostic innovation.
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
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients admitted to emergency department or hospitalized for any cause in participating hospitals with clinically suspected BSI and positive blood culture.
- •At least 18 years of age.
排除标准
- •Have previously taken part in this trial.
- •Concurrently participating in the active phase of a study considered incompatible.
- •Patient with severe or terminal disease with life expectancy shorter than 48 h.
- •Have an existing directive to withhold life-sustaining treatment, in relation to antibiotic use.
研究组 & 干预措施
Experimental arm
Diagnostic approach to blood cultures using rapid microbiological diagnosis testing (R-AST)
干预措施: Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship (Diagnostic Test)
Standard of care
Diagnostic approach to blood cultures using the standard method
干预措施: Standard of Care (SOC) (Diagnostic Test)
结局指标
主要结局
Compare commercially available R-AST testing tools with the current standard of care in BSI patients
时间窗: 24 hours
The primary objective is to determine if a management strategy based on a R-AST test results shorten the time for randomization to antimicrobial stewardship goals compared to standard care. "Antimicrobial stewardship goals" is defined by the administration of an antimicrobial agent that meets both conditions: i) an antimicrobial agent active against the organism(s) documented at conventional AST on blood culture (in vitro); AND ii) an antimicrobial agent targeted for the pathogen(s) identified, and not excessively broad spectrum
次要结局
未报告次要终点