NCT07491419

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 400 (estimated)
• Sponsor: Istituto Clinico Humanitas · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Bloodstream Infection
• Gram-Negative Infections
• Gram-Positive Infections
• Bacteremia Sepsis

Interventions

Type	Name	Description
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).

Timeline

• Start date: 2025-11-19
• Primary completion: 2027-11-19
• Completion: 2027-11-19
• First posted: 2026-03-24
• Last updated: 2026-03-24

Locations

1 site across 1 country: Italy