Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

NCT ID: NCT03218397

Last Updated: 2019-11-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 500 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-09
• Study Completion Date: 2018-11-30

Brief 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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: SINGLE

Study Groups

Standard blood culture and AST

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

Group Type: ACTIVE_COMPARATOR

Standard Culture and AST

Intervention Type: DEVICE

Standard culture and antimicrobial susceptibility testing (AST)

Rapid organism identification and AST

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.

Group Type: ACTIVE_COMPARATOR

Accelerate PhenoTest™ BC Kit

Intervention Type: DEVICE

Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

Interventions

Accelerate PhenoTest™ BC Kit

Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

Intervention Type: DEVICE

Standard Culture and AST

Standard culture and antimicrobial susceptibility testing (AST)

Intervention Type: DEVICE

Eligibility Criteria

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)

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

Sponsor Role: collaborator

Vanderbilt University

OTHER

Sponsor Role: collaborator

Duke University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Ritu Banerjee, MD, PhD

Role: STUDY_CHAIR

Vanderbilt University Medical Center

Locations

University of California, Los Angeles

Los Angeles, California, United States

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

References

Banerjee R, Komarow L, Virk A, Rajapakse N, Schuetz AN, Dylla B, Earley M, Lok J, Kohner P, Ihde S, Cole N, Hines L, Reed K, Garner OB, Chandrasekaran S, de St Maurice A, Kanatani M, Curello J, Arias R, Swearingen W, Doernberg SB, Patel R. Randomized Trial Evaluating Clinical Impact of RAPid IDentification and Susceptibility Testing for Gram-negative Bacteremia: RAPIDS-GN. Clin Infect Dis. 2021 Jul 1;73(1):e39-e46. doi: 10.1093/cid/ciaa528.

Reference Type: DERIVED

PMID: 32374822 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

5UM1AI104681

Identifier Type: NIH

Identifier Source: secondary_id

View Link

Pro00075768

Identifier Type: -

Identifier Source: org_study_id