RECRUITINGINTERVENTIONAL

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

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

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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. Who Should NOT Join This Trial: - 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language

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.

Treatments Being Tested

DIAGNOSTIC_TEST

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.

DIAGNOSTIC_TEST

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).

Locations (1)

Infectious Disease Unit - IRCCS Humanitas Research Hospital

Rozzano, Milan, Italy