The early antibiotic therapy in septic patients--milestone or sticking point?
Michael Bernhard, Christoph Lichtenstern, Christian Eckmann...
https://pubmed.ncbi.nlm.nih.gov/25672873/Actively Recruiting
Led by Istituto Clinico Humanitas · Updated on 2026-06-24
400
Participants Needed
1
Research Sites
N/A
Total Duration
Researchers are evaluating the use of Rapid Antimicrobial Susceptibility Testing R-AST tools compared to the current standard of care in patients with bloodstream infections BSI. The goal is to determine if early targeted antibiotic prescriptions guided by these rapid tests can improve antibiotic use and patient outcomes. This adaptive clinical trial platform allows ongoing evaluation of various R-AST technologies to identify the most effective diagnostic strategies efficiently. Participants are randomly assigned to one of two groups the experimental arm, where blood cultures are tested with R-AST tools providing rapid susceptibility data, and the standard care arm, where cultures follow the usual laboratory workflow. In both groups, test results are shared with treating clinicians who adjust antibiotic therapy accordingly. The trial design permits adjustments in randomization ratios and inclusion of new diagnostic tools over time. Participants are monitored for 28 days to assess clinical outcomes and antibiotic stewardship goals. The study involves standard microbiology cultures and susceptibility testing, with results typically available within 48 to 72 hours. Outcome assessors remain blinded to group assignments to ensure unbiased evaluation. The trial supports continuous innovation by allowing integration of additional R-AST methods in the future.
CONDITIONS
The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)
M
Michele Bartoletti, MD, PhD
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Istituto Clinico Humanitas
Lead Sponsor
BioMérieux
Collaborating Sponsor
You may qualify if you...
You will not qualify if you...
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 28 days
Participants are randomly assigned to either rapid antimicrobial susceptibility testing or standard diagnostic methods to guide antibiotic therapy.
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Lead Sponsor
BioMérieux
Collaborating Sponsor