Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

Gram-negative Bacteremia Clinical Trial

— RAPIDS-GN  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03218397
• Other study ID #: Pro00075768
• Secondary ID: 5UM1AI104681
• Status: Completed
• Phase: N/A
• Start date: October 9, 2017
• Est. completion date: November 30, 2018

Study information

• Verified date: November 2019
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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)

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: November 30, 2018
• Est. primary completion date: November 3, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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)

Related Conditions & MeSH terms

• Bacteremia
• Disease Susceptibility
• Gram-negative Bacteremia

Intervention

Device:
• Accelerate PhenoTest™ BC Kit
Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
• Standard Culture and AST
Standard culture and antimicrobial susceptibility testing (AST)

Locations

Country	Name	City	State
United States	University of California, Los Angeles	Los Angeles	California
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (3)

Lead Sponsor	Collaborator
Duke University	National Institute of Allergy and Infectious Diseases (NIAID), Vanderbilt University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hours to First Antibiotic Modification	Mean hours until first modification of antibiotic therapy within 72 hours post randomization	72 hours after randomization
Secondary	Subjects Who Experienced Mortality Within 30 Days of Randomization	Subjects who experienced mortality within 30 days of randomization	Within 30 days of randomization
Secondary	Length of Stay in the Hospital	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.	Within 30 days of randomization
Secondary	ICU Status Through 72 Hours Post-randomization	ICU status through 72 hours post-randomization	Within 72 hours of randomization
Secondary	Time to First Antibiotic Escalation	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.	Within 72 hours of randomization
Secondary	Time to First Gram-negative Antibiotic Escalation	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.	Within 72 hours of randomization
Secondary	Time to First Gram-positive Antibiotic Escalation	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.	Within 72 hours of randomization
Secondary	Time to First Antibiotic De-escalation	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.	Within 72 hours of randomization
Secondary	Time to First Gram-negative Antibiotic De-escalation	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.	Within 72 hours of randomization
Secondary	Time to First Gram-positive Antibiotic De-escalation	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.	Within 72 hours of randomization
Secondary	Number of Hospital-onset Clostridium Difficile Infections	Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.	Within 30 days of randomization
Secondary	Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.	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)	Within 30 days of randomization