Gram-negative Bacteremia Clinical Trial
Official title:
Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the
following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):
1. Standard culture and antimicrobial susceptibility testing (AST); or
2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the
Accelerate Pheno™ System (AXDX)
RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the
following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):
1. Standard culture and antimicrobial susceptibility testing (AST); or
2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the
Accelerate Pheno™ System (AXDX)
Patient specimens with positive blood culture with Gram stain showing GNB identified during
local laboratory business hours will be enrolled by the Microbiology Laboratory Technologist
if they do not meet any exclusion criteria. Subject specimens will be randomized 1:1 to
standard culture and AST or Rapid identification and AST using the FDA approved Accelerate
Pheno TM System. Both groups will receive standard antimicrobial stewardship (AS). The
primary service, including the prescribing provider, will be unaware of group assignment at
the time of randomization, so initial antibiotic choice will not be affected by group
assignment. Once rapid results become available and/or AS interventions are made, treating
providers may become aware of group assignment.
The goal of this study is to determine the impact of rapid bacterial identification and
phenotypic antimicrobial susceptibility testing (AST) on antimicrobial usage and clinical
outcomes.
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