NCT06174649: FAST

Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

Completed NA Last updated 8 July 2025

What this trial tests

NA trial testing Reveal in Gram-negative Bacteremia in 900 participants. Completed in 18 June 2025.

Timeline

22 December 2023

Primary endpoint
18 June 2025

18 June 2025

Quick facts

Lead sponsor	Duke University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	diagnostic
Enrollment	900
Start date	22 December 2023
Primary completion	18 June 2025
Estimated completion	18 June 2025
Sites	7 locations across Israel, Greece, Spain, India

Drugs / interventions tested

• Reveal

Conditions studied

• Gram-negative Bacteremia — all drugs for Gram-negative Bacteremia →
• Bloodstream Infection — all drugs for Bloodstream Infection →

Sponsor

Duke University

Who can join

Eligibility, any sex, with Gram-negative Bacteremia or Bloodstream Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This study is a 2-arm, multicenter, multinational, prospective, randomized, controlled clinical trial. Hospitalized subjects with blood cultures growing Gram negative bacilli (GNB) will be randomized 1:1 to have the positive blood cultures characterized using standard of care (SOC) antimicrobial susceptibility testing (AST) vs. a rapid AST method known as Reveal™ in addition to SOC AST. The purpose of the FAST trial is to evaluate whether use of a rapid phenotypic AST improves clinical outcomes compared to use of SOC AST methods in clinical settings with high resistance rates.

Publications & conference data

3 peer-reviewed publications reference this trial (live from Europe PMC):

1. An Update on Recent Clinical Trial Data in Bloodstream Infection.
   Stewart AG, Simos P, Sivabalan P, Escolà-Vergé L, et al · · 2024 · cited 5× · PMID 39596730 · DOI 10.3390/antibiotics13111035
2. Fast Antimicrobial Susceptibility Testing for Gram-Negative Bacteremia: The FAST Randomized Clinical Trial.
   Banerjee R, Komarow L, Li Y, Mau D, et al · · 2026 · cited 1× · PMID 41999287 · DOI 10.1001/jama.2026.5487
3. Study protocol for a multicenter, multinational prospective randomized controlled trial comparing outcomes in subjects with Gram-negative bacteremia who have blood culture evaluation using Fast Antibiotic Susceptibility Testing vs. standard of care testing: the FAST trial.
   Banerjee R, Komarow L, Li Y, Wu Q, et al · · 2025 · cited 1× · PMID 41225518 · DOI 10.1186/s13063-025-09228-4