The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)

Condition(s) studied

Investigational drug(s) / intervention(s)

Diagnostic 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.

Standard 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).

Study 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.

Eligibility

Primary outcome measure(s)

• 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

Trial sites (1)

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