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

NCT07491419 | Recruiting DMC

• 1 other identifier: ACT-FAST
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Blood Stream Infection; Gram-negative Infections; Gram-positive Infections; Bacteremia Sepsis

Outcome Measures

Primary Outcomes (1)

• Compare commercially available R-AST testing tools with the current standard of care in BSI patients

  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

  24 hours

Study Arms (2)

Experimental arm

EXPERIMENTAL

Diagnostic approach to blood cultures using rapid microbiological diagnosis testing (R-AST)

Diagnostic Test: Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship

Standard of care

ACTIVE COMPARATOR

Diagnostic approach to blood cultures using the standard method

Diagnostic Test: Standard of Care (SOC)

Interventions

Diagnostic Test: Rapid Antimicrobial Susceptibility Testing (R-AST) guided Stewardship DIAGNOSTIC_TEST

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.

Experimental arm

Standard of Care (SOC) DIAGNOSTIC_TEST

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).

Standard of care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Istituto Clinico Humanitas: lead
• BioMérieux: collaborator

Study Sites (1)

Infectious Disease Unit - IRCCS Humanitas Research Hospital

Rozzano, Milan, 20089, Italy

RECRUITING

Related Publications (16)

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MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Michele Bartoletti, MD, PhD

CONTACT

+ 39 02 8224 3568; michele.bartoletti@hunimed.eu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: It is a multi-center, open-label, parallel, adaptive randomized trial. Groups of randomization: * Genotypic Fast AST * Phenotypic AST * Phenotypic + Genotypic AST

Study Record Dates

• First Submitted: March 18, 2026
• First Posted: March 24, 2026
• Study Start: March 19, 2026
• Primary Completion (Estimated): March 19, 2028
• Study Completion (Estimated): March 19, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Locations

IT (1)