Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ritu Banerjee, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier:
NCT01898208
First received: July 8, 2013
Last updated: September 2, 2014
Last verified: September 2014
  Purpose

Would rapid identification of bacteria and rapid detection of methicillin-resistant S. aureus (MRSA) and vancomycin-resistant enterococci (VRE) (using an FDA-cleared assay) in positive blood culture bottles improve patient care at Mayo Clinic Rochester (or just lead to increased cost)?


Condition Intervention
Bacteremia
Fungemia
Bloodstream Infection
Device: FilmArray testing
Behavioral: Antimicrobial Stewardship

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Diagnostic
Official Title: Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles - A Quality Improvement Theragnostic Stewardship Project

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Broad spectrum antibiotic (e.g. vancomycin and anti-pseudomonal agents) days of therapy per patient [ Time Frame: within 14 days following positive blood culture ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to appropriate antibiotic therapy (# days after gram-stain positive blood culture) [ Time Frame: within 14 days after positive blood culture ] [ Designated as safety issue: No ]
  • Proportion (%) of patients on appropriate antibiotic therapy [ Time Frame: At time of positive blood culture, and 24, 48, and 72 hours after positive blood culture ] [ Designated as safety issue: No ]

Other Outcome Measures:
  • time to pathogen identification (days) [ Time Frame: within 14 days after positive blood culture ] [ Designated as safety issue: No ]
  • length of hospitalization (days) [ Time Frame: from date of positive blood culture to hospital discharge or death ] [ Designated as safety issue: No ]
  • duration of bacteremia or fungemia (days) [ Time Frame: within 30 days after positive blood culture ] [ Designated as safety issue: No ]
  • Total hospital, pharmacy, and laboratory cost per patient [ Time Frame: at 7 days after positive blood culture and for duration of entire hospitalization ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with antibiotic-associated nephrotoxicity, hepatotoxicity, bone marrow suppression or C. difficile-associated diarrhea [ Time Frame: within 14 days after positive blood culture ] [ Designated as safety issue: Yes ]
  • Length of intensive care unit stay (days) [ Time Frame: within 14 days of positive blood culture until ICU discharge ] [ Designated as safety issue: No ]
  • All-cause and attributable mortality [ Time Frame: 30 days after positive blood culture ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with infection or colonization with multidrug resistant organisms (MRSA, VRE, or ESBLs) [ Time Frame: up to 30 days after positive blood culture ] [ Designated as safety issue: No ]
  • Proportion (%) of patients with formal consultation by Infectious Disease service [ Time Frame: within 2 days of positive blood culture ] [ Designated as safety issue: No ]

Enrollment: 617
Study Start Date: August 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
Experimental: FilmArray test
Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture ID Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week.
Device: FilmArray testing
FilmArray Blood Culture ID Panel
Other Name: FilmArray Blood Culture Identification Panel
Experimental: FilmArray plus antimicrobial stewardship
Standard Mayo practices will be used. FilmArray testing will be performed and reported as above, for intervention group 1. IN ADDITION, an expert will review the subject's FilmArray Blood Culture ID Panel result and medical record and contact the primary service if a modification of antimicrobial therapy may be appropriate.
Device: FilmArray testing
FilmArray Blood Culture ID Panel
Other Name: FilmArray Blood Culture Identification Panel
Behavioral: Antimicrobial Stewardship
Real time antimicrobial stewardship

Detailed Description:

We hypothesize that the FilmArray Blood Culture ID Panel will reduce the duration of empiric broad-spectrum antimicrobial therapy typically administered in patients who have positive blood cultures, improving clinical outcome and reducing cost. To test this hypothesis we propose a prospective, randomized controlled study comparing outcomes among patients with positive blood cultures who receive either: Standard culture and antimicrobial susceptibility testing (AST) of positive blood culture bottles as is done today (control), standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel (intervention group 1), or standard culture and AST of positive blood culture bottles plus the FilmArray Blood Culture ID Panel testing along with expert infectious diseases phone consultation (intervention group 2). In both intervention groups, results of the FilmArray test will be communicated by phone to the primary service, along with templated comments about optimal antimicrobial therapy, based on the result. (Templated comments will also be used in the control group). In intervention group 2, an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy, if appropriate, based on microbiology results and clinical information obtained through medical record review and discussion with the primary service.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion criteria:

  • positive blood culture during the study period.
  • No positive blood cultures in prior 7 days
  • Minnesota state research authorization provided

Exclusion criteria:

  • no Minnesota state research authorization
  • deceased at time of positive blood culture result
  • positive blood culture in prior 7 days
  • previously enrolled in this study
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01898208

Locations
United States, Minnesota
Mayo Clinic in Rochester
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Robin Patel, MD Mayo Clinic
Principal Investigator: Ritu Banerjee, MD, Ph.D Mayo Clinic
  More Information

No publications provided

Responsible Party: Ritu Banerjee, M.D., Ph.D., MD, Ph.D, Mayo Clinic
ClinicalTrials.gov Identifier: NCT01898208     History of Changes
Other Study ID Numbers: 11-006920
Study First Received: July 8, 2013
Last Updated: September 2, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Mayo Clinic:
Bacteremia
Fungemia
Bloodstream infection
susceptibility
MRSA
VRE

Additional relevant MeSH terms:
Infection
Disease Susceptibility
Bacteremia
Fungemia
Disease Attributes
Pathologic Processes
Bacterial Infections
Sepsis
Systemic Inflammatory Response Syndrome
Inflammation
Mycoses
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on September 22, 2014