The REMAP-CAP (Randomized Embedded Multifactorial Adaptive Platform for Community-acquired Pneumonia) Study. Rationale and Design.
Derek C Angus, Scott Berry, Roger J Lewis...
https://pubmed.ncbi.nlm.nih.gov/32267771Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID07491419
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
Led by Istituto Clinico Humanitas · Updated on 2026-03-24
400
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
I
Istituto Clinico Humanitas
Lead Sponsor
B
BioMérieux
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating rapid antimicrobial susceptibility testing (R-AST) tools to guide early targeted antibiotic therapy in patients with bloodstream infections (BSI). This adaptive clinical trial compares these rapid tests with the current standard of care to see if they improve antibiotic use and patient outcomes. The study uses a flexible design to assess various R-AST technologies over time within a single protocol. Participants with positive blood cultures are randomized into two groups: one receiving rapid testing with results communicated quickly to clinicians for antibiotic adjustment, and the other receiving standard diagnostic testing following usual laboratory procedures. Both groups undergo routine susceptibility testing, with standard results available after 48 to 72 hours. Randomization ratios may change as new diagnostic tools are added to the trial. Participants are followed for 28 days to monitor clinical outcomes and antibiotic stewardship goals. The study collects data on how quickly and effectively antibiotics are targeted based on test results. Outcome assessors remain unaware of group assignments to maintain objectivity. The trial allows new rapid diagnostic methods to be integrated as they become available, keeping the study current with emerging technologies.
CONDITIONS
Brief Title
The Impact of Fast Antimicrobial Sensitivity Testing Tools on Stewardship Antibiotic and Clinical Outcome (ACT-FAST)
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Patients admitted to emergency department or hospitalized for any cause in participating hospitals with clinically suspected bloodstream infection and positive blood culture.
- At least 18 years of age.
You will not qualify if you...
- 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 hours.
- Have an existing directive to withhold life-sustaining treatment, in relation to antibiotic use.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - Up to 3 days
Participants undergo blood culture testing using either rapid antimicrobial susceptibility testing (R-AST) or the standard diagnostic method to identify pathogens and determine antibiotic susceptibility.
1 visit (in-person)
Long-term Monitoring
Duration - 28 days
Participants are followed for clinical outcomes and antibiotic stewardship objectives after diagnostic testing and treatment adjustments based on test results.
Follow-up visits as per clinical care during 28 days
Trial Site Locations
Total: 1 location
1
Infectious Disease Unit - IRCCS Humanitas Research Hospital
Rozzano, Milan, Italy, 20089
Actively Recruiting
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Research Team
M
Michele Bartoletti, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
2
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Julian Mettler, Mathew Simcock, Pedram Sendi...
https://pubmed.ncbi.nlm.nih.gov/17386104Health care--associated bloodstream infections in adults: a reason to change the accepted definition of community-acquired infections.
N Deborah Friedman, Keith S Kaye, Jason E Stout...
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F Mulatero, V Bonnardel, C Micolaud
https://pubmed.ncbi.nlm.nih.gov/21521410