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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)

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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

Tracking Information
First Submitted Date  ICMJE July 11, 2017
First Posted Date  ICMJE July 14, 2017
Results First Submitted Date  ICMJE October 17, 2019
Results First Posted Date  ICMJE November 26, 2019
Last Update Posted Date November 26, 2019
Actual Study Start Date  ICMJE October 9, 2017
Actual Primary Completion Date November 3, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
Hours to First Antibiotic Modification [ Time Frame: 72 hours after randomization ]
Mean hours until first modification of antibiotic therapy within 72 hours post randomization
Original Primary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
Time to first antibiotic modification [ Time Frame: In the first 72 hours after randomization. ]
Mean time until first modification of antibiotic therapy (in hours) within 72 hours post randomization
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 7, 2019)
  • 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
  • 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.
  • ICU Status Through 72 Hours Post-randomization [ Time Frame: Within 72 hours of randomization ]
    ICU status through 72 hours post-randomization
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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.
  • 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)
Original Secondary Outcome Measures  ICMJE
 (submitted: July 12, 2017)
  • Mortality [ Time Frame: Within 30 days of randomization ]
    Mortality within 30 days of randomization using the Accurint death index
  • 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 those patients alive at 30 days. Length of stay will be date of discharge minus date of randomization.
  • Days in the ICU [ Time Frame: Within 30 days of randomization ]
    Days in the ICU during hospitalization after randomization, up to 30 days, for those patients alive at 30 days.
  • Standardized costs [ Time Frame: Within 30 days of randomization ]
    Aggregate standardized costs, obtained from the UHC/Vizient database
  • Duration of antibiotic therapy [ Time Frame: Within 72 hours of randomization ]
    Duration of antibiotic therapy on broad-spectrum gram negative coverage in the first 72 hours following randomization
  • Time to antibiotic escalation [ Time Frame: Within 72 hours of randomization ]
    Mean time to antibiotic escalation in those who have antibiotic escalation within 72 hours from randomization. This will be further broken down by whether the escalation was in gram positive coverage, gram negative coverage, or both.
  • Mean time to antibiotic de-escalation [ Time Frame: Within 72 hours of randomization ]
    Mean time to antibiotic de-escalation in those who have antibiotic de-escalation within 72 hours from randomization. This will be further broken down by whether the de-escalation was in gram positive coverage, gram negative coverage, or both.
  • Hospital-onset Clostridium difficile [ Time Frame: Within 30 days of randomization ]
    Hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN). This will be normalized to patient-days
  • Acquisition of new hospital-acquired infections (HAIs) and/or multidrug resistant organisms (MDROs) measured as the summation of all HAIs and MDROs and reported as one value [ 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. This will be normalized to patient-days. 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)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
Official Title  ICMJE Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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
Condition  ICMJE Gram-negative Bacteremia
Intervention  ICMJE
  • Device: Accelerate PhenoTest™ BC Kit
    Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
  • Device: Standard Culture and AST
    Standard culture and antimicrobial susceptibility testing (AST)
Study Arms  ICMJE
  • Active Comparator: Standard blood culture and AST
    Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
    Intervention: Device: Standard Culture and 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.
    Intervention: Device: Accelerate PhenoTest™ BC Kit
Publications * 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; Antibacterial Resistance Leadership Group. Randomized trial evaluating clinical impact of RAPid IDentification and Susceptibility testing for Gram Negative bacteremia (RAPIDS-GN). Clin Infect Dis. 2020 May 7. pii: ciaa528. doi: 10.1093/cid/ciaa528. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 12, 2017)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE November 30, 2018
Actual Primary Completion Date November 3, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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)
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03218397
Other Study ID Numbers  ICMJE Pro00075768
5UM1AI104681 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Duke University
Study Sponsor  ICMJE Duke University
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Vanderbilt University
Investigators  ICMJE
Study Chair: Ritu Banerjee, MD, PhD Vanderbilt University Medical Center
PRS Account Duke University
Verification Date November 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP