Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

NCT03218397 | Completed Results FDA Device

• 2 other identifiers: Pro000757685UM1AI104681
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 2

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. 1.Standard culture and antimicrobial susceptibility testing (AST); or
2. 2.Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

Conditions

Gram-negative Bacteremia

Keywords

Gram-negative Bacteremia; ICU; Critically ill; Intensive Care Unit; Rapid identification; Rapid susceptibility; Accelerate PhenoTest™ BC Kit; Accelerate Pheno™ System (AXDX); Antimicrobial stewardship; Antimicrobial use

Outcome Measures

Primary Outcomes (1)

• Hours to First Antibiotic Modification

  Mean hours until first modification of antibiotic therapy within 72 hours post randomization

  72 hours after randomization

Secondary Outcomes (11)

• Subjects Who Experienced Mortality Within 30 Days of Randomization

  Within 30 days of randomization

• Length of Stay in the Hospital

  Within 30 days of randomization

• ICU Status Through 72 Hours Post-randomization

  Within 72 hours of randomization

• Time to First Antibiotic Escalation

  Within 72 hours of randomization

• Time to First Gram-negative Antibiotic Escalation

  Within 72 hours of randomization

Study Arms (2)

Standard blood culture and AST

ACTIVE COMPARATOR

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

Device: Standard Culture and AST

Rapid organism identification and AST

ACTIVE COMPARATOR

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.

Device: Accelerate PhenoTest™ BC Kit

Interventions

Accelerate PhenoTest™ BC Kit DEVICE

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

Rapid organism identification and AST

Standard Culture and AST DEVICE

Standard culture and antimicrobial susceptibility testing (AST)

Standard blood culture and AST

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator
• Vanderbilt University: collaborator

Study Sites (2)

University of California, Los Angeles

Los Angeles, California, 90049, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related Publications (1)

• 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.

  PMID: 32374822 DERIVED

MeSH Terms

Conditions

Critical Illness

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Vance Fowler, MD, MHS
• Organization: Duke University

vance.fowler@duke.edu

919-613-5678

Study Officials

• Ritu Banerjee, MD, PhD

  Vanderbilt University Medical Center

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Masking Details: Primary service/provider: 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.
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 11, 2017
• First Posted: July 14, 2017
• Study Start: October 9, 2017
• Primary Completion: November 3, 2018
• Study Completion: November 30, 2018
• Last Updated: November 26, 2019
• Results First Posted: November 26, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)