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 type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 400 (estimated) |
| Sponsor | Istituto Clinico Humanitas Academic / other |
| Locations | 1 site (Rozzano, Milan) |
| Status | Recruiting |
| Started | March 19, 2026 |
| Main results expected | March 19, 2028 |
| Study ends | March 19, 2028 |
| Registry record updated | June 24, 2026 |
| Trial ID | NCT07491419 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
- Study coordinator: Michele Bartoletti, MD, PhD
- Email: michele.bartoletti@hunimed.eu
- Phone: + 39 02 8224 3568
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Oral switch for bloodstream infections in immunocompromised children
This trial tests whether switching from IV to oral antibiotics is just as safe as continuing IV therapy for children with bloodstream infections who are immunocompromised or have a central venous catheter.
-
Oral switch for kids with bloodstream infections after starting IV therapy
This trial will test whether switching from IV to oral antibiotics early is not worse than continuing IV treatment for previously healthy children and teens with uncomplicated bloodstream infections.
-
Personalized antibiotic duration for high-risk febrile neutropenia with Gram-negative bloodstream infection
This trial tests whether stopping antibiotics after a patient with a blood cancer and febrile neutropenia has been clinically stable for 72 hours is as safe and lets them spend more days off anti–Gram-negative antibiotics than the usual at least 10-day approach.
-
Middle East study of bloodstream infections in blood cancer patients and HSCT recipients
This is an observational study to see how bloodstream infections affect adults with blood cancers or after stem cell transplants across several Middle East countries.
-
Sulbactam-Durlobactam for CRAB infections in real-world care
This real-world study tests whether sulbactam-durlobactam works and is safe for adults with carbapenem-resistant Acinetobacter baumannii infections, compared with other anti-CRAB treatments.
-
Ceftazidime (±avibactam) with IV fosfomycin versus ceftazidime alone for hospitalized adults with severe suspected Gram‑negative infection
This trial will test whether adding intravenous fosfomycin to ceftazidime (or ceftazidime‑avibactam) helps hospitalized adults with suspected severe Gram‑negative infections recover faster than ceftazidime alone.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.