Fast Antibiotic Susceptibility Testing for Gram Negative Bacteremia Trial

Overview

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.

Eligibility

Inclusion Criteria:

1. Positive blood culture with Gram stain showing GNB
2. Hospitalized at the time of Gram stain result
3. Enrolled within 16 hours of blood culture positivity

Exclusion Criteria:

1. Positive blood culture for GNB within the prior 7 days (if known at the time of Gram stain result)
2. Deceased at the time of Gram stain result
3. Gram-positive bacilli, Gram-positive cocci, Gram-negative cocci, yeast, fungi, or multiple morphologies of GNB detected on Gram stain of blood culture
4. Previous enrollment in this study