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Recruiting NCT07491419

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

Trial Parameters

Condition Bloodstream Infection
Sponsor Istituto Clinico Humanitas
Study Type INTERVENTIONAL
Phase N/A
Enrollment 400
Sex ALL
Min Age 18 Years
Max Age N/A
Start Date 2025-11-19
Completion 2027-11-19
Interventions
Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided StewardshipStandard of Care (SOC)

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.

Eligibility Criteria

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.

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