NCT03218397

Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 500 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Gram-negative Bacteremia

Interventions

Type	Name	Description
DEVICE	Accelerate PhenoTest™ BC Kit	Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
DEVICE	Standard Culture and AST	Standard culture and antimicrobial susceptibility testing (AST)

Timeline

• Start date: 2017-10-09
• Primary completion: 2018-11-03
• Completion: 2018-11-30
• First posted: 2017-07-14
• Last updated: 2019-11-26
• Results posted: 2019-11-26

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study