Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

Not Applicable

Completed

• Conditions: Gram-negative Bacteremia
• Interventions: Device: Accelerate PhenoTest™ BC Kit; Device: Standard Culture and AST

• Registration Number: NCT03218397
• Lead Sponsor: 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)

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 Timeline

• Study First Submitted: 2017-07-11
• Study First Submitted QC: 2017-07-12
• Study First Posted: 2017-07-14
• Study Start: 2017-10-09
• Primary Completion: 2018-11-03
• Study Completion: 2018-11-30
• Results First Submitted: 2019-10-17
• Status Verified: 2019-11
• Results First Submitted QC: 2019-11-07
• Last Update Submitted: 2019-11-07
• Results First Posted: 2019-11-26
• Last Update Posted: 2019-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 500

Inclusion Criteria

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

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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)

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rapid organism identification and AST	Accelerate PhenoTest™ BC Kit	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.
Standard blood culture and AST	Standard Culture and AST	Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Time to First Antibiotic Escalation	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.
Subjects Who Experienced Mortality Within 30 Days of Randomization	Within 30 days of randomization	Subjects who experienced mortality within 30 days of randomization
Length of Stay in the Hospital	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	Within 72 hours of randomization	ICU status through 72 hours post-randomization
Time to First Gram-negative Antibiotic Escalation	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	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	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-positive Antibiotic De-escalation	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	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.	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)
Time to First Gram-negative Antibiotic De-escalation	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.

Trial Locations

Locations (2)

Mayo Clinic; 🇺🇸 Rochester, Minnesota, United States

University of California, Los Angeles; 🇺🇸 Los Angeles, California, United States