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Completed

NCT Number: NCT03218397

Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

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)

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Key information

Conditions

Gram-negative Bacteremia Critical Illness Disease Attributes Pathologic Processes Pathological Conditions, Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Los Angeles, Los Angeles, California, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Accelerate PhenoTest™ BC Kit

Device

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

Standard Culture and AST

Device

Standard culture and antimicrobial susceptibility testing (AST)

Primary outcomes

  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 outcomes

  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)

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Vanderbilt University

Registry information

Official study title

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

Acronym: RAPIDS-GN

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Jul 14, 2017
Registry last updated
Nov 26, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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