Clinical trial NCT03218397: Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
Official title: Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: 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
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: Vanderbilt University
First posted: 2017-07-14
Enrollment: 500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

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)

Primary outcomes:
measure: Hours to First Antibiotic Modification
timeFrame: 72 hours after randomization
Secondary outcomes:
measure: Subjects Who Experienced Mortality Within 30 Days of Randomization
timeFrame: Within 30 days of randomization
measure: Length of Stay in the Hospital
timeFrame: Within 30 days of randomization
measure: ICU Status Through 72 Hours Post-randomization
timeFrame: Within 72 hours of randomization
measure: Time to First Antibiotic Escalation
timeFrame: Within 72 hours of randomization
measure: Time to First Gram-negative Antibiotic Escalation
timeFrame: Within 72 hours of randomization
measure: Time to First Gram-positive Antibiotic Escalation
timeFrame: Within 72 hours of randomization
measure: Time to First Antibiotic De-escalation
timeFrame: Within 72 hours of randomization
measure: Time to First Gram-negative Antibiotic De-escalation
timeFrame: Within 72 hours of randomization
measure: Time to First Gram-positive Antibiotic De-escalation
timeFrame: Within 72 hours of randomization
measure: Number of Hospital-onset Clostridium Difficile Infections
timeFrame: Within 30 days of randomization
measure: Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.
timeFrame: Within 30 days of randomization
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: University of California, Los Angeles
state: California
city: Rochester
country: United States
facility: Mayo Clinic
state: Minnesota
Study officials:
affiliation: Vanderbilt University Medical Center
name: Ritu Banerjee, MD, PhD
role: STUDY_CHAIR
References:
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.