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

ConditionsBloodstream Infection Gram-Negative Infections Gram-Positive Infections Bacteremia Sepsis

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorIstituto Clinico Humanitas

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

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.
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).

Treatment groups

400 Participants

are divided into 2 treatment groups

Group A: Experimental armExperimental treatment 1 intervention

Group B: Standard of careActive comparator 1 intervention

Trial outcomes

Primary outcomes

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

Time frame

24 hours

Sponsors and contacts

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Istituto Clinico Humanitas

Lead sponsor

BioMérieux

Collaborator

Source ClinicalTrials.gov

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