search
Back to results

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

Primary Purpose

Gram-negative Bacteremia

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Accelerate PhenoTest™ BC Kit
Standard Culture and AST
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Gram-negative Bacteremia focused on measuring 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

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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)

Sites / Locations

  • University of California, Los Angeles
  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Standard blood culture and AST

Rapid organism identification and AST

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Hours to First Antibiotic Modification
Mean hours until first modification of antibiotic therapy within 72 hours post randomization

Secondary Outcome Measures

Subjects Who Experienced Mortality Within 30 Days of Randomization
Subjects who experienced mortality within 30 days of randomization
Length of Stay in the Hospital
Length of stay in the hospital after randomization, up to 30 days, for patients alive at 30 days. Length of stay will be date of discharge minus date of randomization.
ICU Status Through 72 Hours Post-randomization
ICU status through 72 hours post-randomization
Time to First Antibiotic Escalation
Mean hours to first antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time to First Gram-negative Antibiotic Escalation
Mean hours to first gram-negative antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time to First Gram-positive Antibiotic Escalation
Mean hours to first gram-positive antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time to First Antibiotic De-escalation
Mean hours to first antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time to First Gram-negative Antibiotic De-escalation
Mean hours to first gram-negative antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time to First Gram-positive Antibiotic De-escalation
Mean hours to first gram-positive antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Number of Hospital-onset Clostridium Difficile Infections
Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.
Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.
Acquisition of new hospital-acquired infections (HAIs) and/or multidrug resistant organisms (MDROs) within 30 days during index hospitalization identified on routine clinical or surveillance samples. Cultures that will be tracked include the following, from any specimen source, unless otherwise indicated: Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus 3rd generation cephalosporin non-susceptible Enterobacteriaceae Carbapenem-resistant Enterobacteriaceae, as defined by the Centers for Disease Control and Prevention (CDC): resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate possesses a carbapenemase Multidrug-resistant Pseudomonas aeruginosa (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter Candida species (isolated from blood cultures only)

Full Information

First Posted
July 11, 2017
Last Updated
November 7, 2019
Sponsor
Duke University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Vanderbilt University
search

1. Study Identification

Unique Protocol Identification Number
NCT03218397
Brief Title
Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
Acronym
RAPIDS-GN
Official Title
Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
October 9, 2017 (Actual)
Primary Completion Date
November 3, 2018 (Actual)
Study Completion Date
November 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID), Vanderbilt University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Data Monitoring Committee
No

5. Study Description

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): Standard culture and antimicrobial susceptibility testing (AST); or 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): Standard culture and antimicrobial susceptibility testing (AST); or 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
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

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Care Provider
Masking Description
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.
Allocation
Randomized
Enrollment
500 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Standard blood culture and AST
Arm Type
Active Comparator
Arm Description
Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
Arm Title
Rapid organism identification and AST
Arm Type
Active Comparator
Arm 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.
Intervention Type
Device
Intervention Name(s)
Accelerate PhenoTest™ BC Kit
Intervention Description
Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
Intervention Type
Device
Intervention Name(s)
Standard Culture and AST
Intervention Description
Standard culture and antimicrobial susceptibility testing (AST)
Primary Outcome Measure Information:
Title
Hours to First Antibiotic Modification
Description
Mean hours until first modification of antibiotic therapy within 72 hours post randomization
Time Frame
72 hours after randomization
Secondary Outcome Measure Information:
Title
Subjects Who Experienced Mortality Within 30 Days of Randomization
Description
Subjects who experienced mortality within 30 days of randomization
Time Frame
Within 30 days of randomization
Title
Length of Stay in the Hospital
Description
Length of stay in the hospital after randomization, up to 30 days, for patients alive at 30 days. Length of stay will be date of discharge minus date of randomization.
Time Frame
Within 30 days of randomization
Title
ICU Status Through 72 Hours Post-randomization
Description
ICU status through 72 hours post-randomization
Time Frame
Within 72 hours of randomization
Title
Time to First Antibiotic Escalation
Description
Mean hours to first antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time Frame
Within 72 hours of randomization
Title
Time to First Gram-negative Antibiotic Escalation
Description
Mean hours to first gram-negative antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time Frame
Within 72 hours of randomization
Title
Time to First Gram-positive Antibiotic Escalation
Description
Mean hours to first gram-positive antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time Frame
Within 72 hours of randomization
Title
Time to First Antibiotic De-escalation
Description
Mean hours to first antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time Frame
Within 72 hours of randomization
Title
Time to First Gram-negative Antibiotic De-escalation
Description
Mean hours to first gram-negative antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time Frame
Within 72 hours of randomization
Title
Time to First Gram-positive Antibiotic De-escalation
Description
Mean hours to first gram-positive antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time Frame
Within 72 hours of randomization
Title
Number of Hospital-onset Clostridium Difficile Infections
Description
Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.
Time Frame
Within 30 days of randomization
Title
Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.
Description
Acquisition of new hospital-acquired infections (HAIs) and/or multidrug resistant organisms (MDROs) within 30 days during index hospitalization identified on routine clinical or surveillance samples. Cultures that will be tracked include the following, from any specimen source, unless otherwise indicated: Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus 3rd generation cephalosporin non-susceptible Enterobacteriaceae Carbapenem-resistant Enterobacteriaceae, as defined by the Centers for Disease Control and Prevention (CDC): resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate possesses a carbapenemase Multidrug-resistant Pseudomonas aeruginosa (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter Candida species (isolated from blood cultures only)
Time Frame
Within 30 days of randomization

10. Eligibility

Sex
All
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ritu Banerjee, MD, PhD
Organizational Affiliation
Vanderbilt University Medical Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90049
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
32374822
Citation
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.
Results Reference
derived

Learn more about this trial

Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

We'll reach out to this number within 24 hrs