Clinical trial Recruiting at 1 site Interventional Ages 18 and up

Fast antibiotic sensitivity tests to guide treatment for bloodstream infections

Official title: 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

Run by Istituto Clinico Humanitas · NCT07491419 · Data updated 2026-11-12

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

Study typeInterventional
Ages18 Years and up
SexAll
Enrollment400 (estimated)
SponsorIstituto Clinico Humanitas
Academic / other
Locations1 site (Rozzano, Milan)
StatusRecruiting
StartedMarch 19, 2026
Main results expectedMarch 19, 2028
Study endsMarch 19, 2028
Registry record updatedJune 24, 2026
Trial IDNCT07491419 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably 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.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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 gone: 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.

Who can join: the full rules

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 it's running

  • Infectious Disease Unit - IRCCS Humanitas Research Hospital
    Rozzano, Milan, Italy
    Recruiting

Study contacts

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.