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Trial record 1 of 1 for:    NCT03218397
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Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03218397
Recruitment Status : Completed
First Posted : July 14, 2017
Results First Posted : November 26, 2019
Last Update Posted : November 26, 2019
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
Vanderbilt University
Information provided by (Responsible Party):
Duke University

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)

Condition or disease Intervention/treatment Phase
Gram-negative Bacteremia Device: Accelerate PhenoTest™ BC Kit Device: Standard Culture and AST Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 500 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (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.
Primary Purpose: Diagnostic
Official Title: Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
Actual Study Start Date : October 9, 2017
Actual Primary Completion Date : November 3, 2018
Actual Study Completion Date : November 30, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
Active Comparator: Standard blood culture and AST
Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
Device: Standard Culture and AST
Standard culture and antimicrobial susceptibility testing (AST)

Active Comparator: 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.
Device: Accelerate PhenoTest™ BC Kit
Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)




Primary Outcome Measures :
  1. Hours to First Antibiotic Modification [ Time Frame: 72 hours after randomization ]
    Mean hours until first modification of antibiotic therapy within 72 hours post randomization


Secondary Outcome Measures :
  1. Subjects Who Experienced Mortality Within 30 Days of Randomization [ Time Frame: Within 30 days of randomization ]
    Subjects who experienced mortality within 30 days of randomization

  2. Length of Stay in the Hospital [ Time Frame: Within 30 days of randomization ]
    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.

  3. ICU Status Through 72 Hours Post-randomization [ Time Frame: Within 72 hours of randomization ]
    ICU status through 72 hours post-randomization

  4. Time to First Antibiotic Escalation [ Time Frame: Within 72 hours of randomization ]
    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.

  5. Time to First Gram-negative Antibiotic Escalation [ Time Frame: Within 72 hours of randomization ]
    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.

  6. Time to First Gram-positive Antibiotic Escalation [ Time Frame: Within 72 hours of randomization ]
    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.

  7. Time to First Antibiotic De-escalation [ Time Frame: Within 72 hours of randomization ]
    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.

  8. Time to First Gram-negative Antibiotic De-escalation [ Time Frame: Within 72 hours of randomization ]
    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.

  9. Time to First Gram-positive Antibiotic De-escalation [ Time Frame: Within 72 hours of randomization ]
    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.

  10. Number of Hospital-onset Clostridium Difficile Infections [ Time Frame: Within 30 days of randomization ]
    Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.

  11. Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days. [ Time Frame: Within 30 days of randomization ]

    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)



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03218397


Locations
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United States, California
University of California, Los Angeles
Los Angeles, California, United States, 90049
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Duke University
National Institute of Allergy and Infectious Diseases (NIAID)
Vanderbilt University
Investigators
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Study Chair: Ritu Banerjee, MD, PhD Vanderbilt University Medical Center
  Study Documents (Full-Text)

Documents provided by Duke University:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT03218397    
Other Study ID Numbers: Pro00075768
5UM1AI104681 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2017    Key Record Dates
Results First Posted: November 26, 2019
Last Update Posted: November 26, 2019
Last Verified: November 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Duke University:
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
Additional relevant MeSH terms:
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Bacteremia
Disease Susceptibility
Disease Attributes
Pathologic Processes
Bacterial Infections
Sepsis
Infection
Systemic Inflammatory Response Syndrome
Inflammation