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

Duke University

Status: Completed

Conditions: Gram-negative Bacteremia

Treatments: Device: Accelerate PhenoTest™ BC Kit; Device: Standard Culture and AST

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03218397

5UM1AI104681 (U.S. NIH Grant/Contract)

Pro00075768

Details and patient eligibility

About

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)

Full 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.

Enrollment: 500 patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.

Exclusion criteria

• Identification of GNB outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
• Positive blood culture for GNB at the same institution within prior 7 days (if known at the time of randomization).
• Deceased at the time of randomization.
• GNB plus gram-positive organism, gram-negative cocci, and/or yeast detected on Gram stain
• Previous enrollment in this study
• No Minnesota research authorization (Rochester site only)

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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500 participants in 2 patient groups

Standard blood culture and AST

Active Comparator group

Description:

Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.

Treatment:

Device: Standard Culture and AST

Rapid organism identification and AST

Active Comparator group

Description:

Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.

Treatment:

Device: Accelerate PhenoTest™ BC Kit