Fast antibiotic sensitivity tests to guide treatment for bloodstream infections
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
This tests whether rapid antibiotic susceptibility tests can help doctors pick the right antibiotics sooner for adults with positive blood cultures and improve recovery and antibiotic use.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 400 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milan) |
| Trial ID | NCT07491419 on ClinicalTrials.gov |
What this trial studies
ACT-FAST is a multicenter, open-label, randomized adaptive platform that compares rapid antimicrobial susceptibility testing (R-AST) tools with standard laboratory workflows for patients with positive blood cultures. Participants are randomized to R-AST-guided reporting or to the site’s usual diagnostics, with treating clinicians adjusting antibiotics based on the results and clinical judgment. The adaptive design allows new R-AST technologies to be added over time and randomization ratios to be modified as evidence accumulates. Patients are followed for 28 days to compare antimicrobial stewardship metrics and clinical outcomes between strategies.
Who should consider this trial
Good fit: Adults aged 18 or older who are hospitalized or seen in the emergency department with clinically suspected bloodstream infection and a positive blood culture, and who meet enrollment criteria without conflicting study participation or imminent terminal status.
Not a fit: Patients with a life expectancy under 48 hours, existing directives to withhold life-sustaining treatment related to antibiotics, or those already enrolled in incompatible active studies may not receive benefit from participation.
Why it matters
Potential benefit: If successful, patients could receive more targeted antibiotics sooner, potentially reducing unnecessary broad-spectrum use and improving recovery.
How similar studies have performed: Previous studies of rapid diagnostic and susceptibility tools have generally shown faster time to targeted therapy and reduced broad-spectrum antibiotic use, though impacts on mortality and some clinical outcomes have been mixed.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria: * 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.
Where this trial is running
Rozzano, Milan
- Infectious Disease Unit - IRCCS Humanitas Research Hospital — Rozzano, Milan, Italy (Recruiting)
Study contacts
- Study coordinator: Michele Bartoletti, MD, PhD
- Email: michele.bartoletti@hunimed.eu
- Phone: + 39 02 8224 3568
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.