Bacteremia Sepsis, Bloodstream Infection, Gram-Negative Infections, Gram-Positive Infections
Conditions
Keywords
Blood Stream Infection, Gram-negative Infections, Gram-positive Infections, Bacteremia Sepsis
Brief summary
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.
Detailed description
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.
Interventions
DIAGNOSTIC_TESTDiagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship
In patients randomized to the intervention arm, the test under evaluation will be performed by the Humanitas Core Lab on positive blood cultures. The test is expected to provide results in a certain amount of time. The Lab will notify the ID consultant as soon as the test provides the first result (even if partial). The ID physician is expected to revise the antibiotic therapy according to the identified species, guided by the tool.
DIAGNOSTIC_TESTStandard of Care (SOC)
Patients will be managed as usual, which typically consists of receiving standard empirical antibiotics, according to the local prescribing policy, continued until the results of the routine standard AST protocol in current use. In any case, both arms have standard microbiology culture and susceptibility testing performed, according to standard laboratory procedures and current guidelines, with results typically available after 48-72 hours from a blood culture positive result (day 3).
Sponsors
Istituto Clinico Humanitas
BioMérieux
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
It is a multi-center, open-label, parallel, adaptive randomized trial. Groups of randomization: * Genotypic Fast AST * Phenotypic AST * Phenotypic + Genotypic AST
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Compare commercially available R-AST testing tools with the current standard of care in BSI patients | 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 |
Countries
Italy
Contacts
CONTACTMichele Bartoletti, MD, PhD
Outcome results
None listed