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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
Location: See location...
Intervention Type: Diagnostic test
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
Infectious Disease Unit - IRCCS Humanitas Research Hospital
RECRUITING
Rozzano
Contact Information
Primary
Michele Bartoletti, MD, PhD
michele.bartoletti@hunimed.eu
+ 39 02 8224 3568
Time Frame
Start Date: 2025-11-19
Estimated Completion Date: 2027-11-19
Participants
Target number of participants: 400
Treatments
Experimental: Experimental arm
Diagnostic approach to blood cultures using rapid microbiological diagnosis testing (R-AST)
Active_comparator: Standard of care
Diagnostic approach to blood cultures using the standard method
Related Therapeutic Areas
Sponsors
Leads: Istituto Clinico Humanitas
Collaborators: BioMérieux

This content was sourced from clinicaltrials.gov