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Trial record 11 of 758 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

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ClinicalTrials.gov Identifier: NCT01898208
Recruitment Status : Completed
First Posted : July 12, 2013
Results First Posted : March 15, 2016
Last Update Posted : March 15, 2016
Sponsor:
Collaborators:
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Advancing Translational Science (NCATS)
Information provided by (Responsible Party):
Ritu Banerjee, M.D., Ph.D., Mayo Clinic

Tracking Information
First Submitted Date  ICMJE July 8, 2013
First Posted Date  ICMJE July 12, 2013
Results First Submitted Date  ICMJE December 2, 2015
Results First Posted Date  ICMJE March 15, 2016
Last Update Posted Date March 15, 2016
Study Start Date  ICMJE August 2013
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
Duration of Antimicrobial Therapy (Hours) [ Time Frame: Approximately 4 days after enrollment ]
Difference between the date and time of the antibiotic start order (or Gram stain-positive blood culture, if antibiotics were started prior to the positive culture result) and the date and time of the antibiotic stop order. Shorter duration of broad spectrum antibiotics and longer duration of narrow-spectrum antibiotics were considered favorable outcomes.
Original Primary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
Vancomycin and anti-pseudomonal antibiotic days of therapy per patient [ Time Frame: within 14 days following gram-stain positive blood culture ]
Change History Complete list of historical versions of study NCT01898208 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 17, 2016)
  • Time From Positive Gram Stain to First Active Antibiotic [ Time Frame: Approximately 14 days after positive blood culture ]
    From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.
  • Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics [ Time Frame: Positive Gram stain, 96 hours after enrollment ]
    De-escalation included discontinuation of 1 or more antibiotics and/or switching from a broad- to a narrow spectrum antibiotic. Escalation included initiation of 1 or more antibiotics and/or switching from a narrow- to a broad-spectrum antibiotic.
  • Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours [ Time Frame: Within 14 days after positive blood culture ]
    Contaminated blood cultures were defined as growth of organisms such as coagulase-negative staphylococci from a single blood culture set when greater than or equal to 2 blood culture sets were collected, except among subjects suspected to have true bacteremia associated with central venous catheters or devices.
  • Time to Pathogen Identification [ Time Frame: Approximately 14 days after positive blood culture ]
  • Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment [ Time Frame: 3 Days after enrollment ]
  • Length of Entire Hospitalization (Days) [ Time Frame: Participants were followed for the duration of hospital stay, approximately 15 days ]
  • All-cause and Attributable Mortality [ Time Frame: 30 days after positive blood culture ]
    If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.
  • Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events [ Time Frame: Approximately 14 days after positive blood culture ]
    This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.
  • Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment [ Time Frame: Approximately within 72 hours of positive blood culture ]
  • Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject [ Time Frame: Approximately 7 days after positive blood culture and for duration of entire hospitalization ]
    Costs were calculated using a standardized inflation-adjusted estimate of costs for each service or procedure performed in constant dollars. This approach adjusts for hospital-billed charges with Medicare Cost Report department-level cost-to-charge ratios. Physician services were proxied with Medicare reimbursement rates based on Current Procedure Terminology (CPT)-4 codes using the Medicare Fee Schedule. We did not include the cost of the stewardship program in the cost analysis, as it is not a billed service. As there was no Medicare reimbursement rate for the rmPCR test at the time of the study, test cost was proxied using the FilmArray respiratory panel. These costs were varied in sensitivity analysis with rmPCR test cost ranging from a 50% decrease to a 300% increase.
Original Secondary Outcome Measures  ICMJE
 (submitted: July 11, 2013)
Time to appropriate antibiotic deescalation or escalation (# days after gram-stain positive blood culture) [ Time Frame: within 14 days after gram-stain positive blood culture ]
Current Other Pre-specified Outcome Measures
 (submitted: February 17, 2016)
  • Length of Intensive Care Unit Stay [ Time Frame: within 14 days of positive blood culture until ICU discharge ]
  • Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment [ Time Frame: Approximately 30 days after positive blood culture ]
    Multidrug-resistant organisms included vancomycin-resistant enterococci, methicillin-resistant Staphylococcus aureus, extended-spectrum cephalosporin-resistant Enterobacteriaceae, and Pseudomonas aeruginosa and Acinetobacter species resistant to greater than or equal to 3 antibiotic classes.
Original Other Pre-specified Outcome Measures
 (submitted: July 11, 2013)
  • time to pathogen identification (days) [ Time Frame: within 14 days after positive blood culture ]
  • length of hospital and intensive care unit stay (days) [ Time Frame: from date of randomization to hospital discharge or death ]
  • duration of bacteremia or fungemia (days) [ Time Frame: within 14 days after gram-stain positive blood culture ]
  • Total hospital, pharmacy, and laboratory cost per patient [ Time Frame: at 14 days after gram-stain positive blood culture ]
  • Proportion of patients (%) with antibiotic-associated nephrotoxicity or C. difficile-associated diarrhea [ Time Frame: within 30 days after gram-stain positive blood culture ]
 
Descriptive Information
Brief Title  ICMJE Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures
Official Title  ICMJE Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles - A Quality Improvement Theragnostic Stewardship Project
Brief Summary 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)?
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Bacteremia
  • Fungemia
  • Bloodstream Infection
Intervention  ICMJE
  • Device: FilmArray testing
    FilmArray Blood Culture Identification (BCID) Panel is a polymerase chain reaction (PCR) panel that identifies 19 types of bacteria, 5 types of fungi, and select antimicrobial-resistance genes.
    Other Name: FilmArray Blood Culture Identification Panel
  • Behavioral: Antimicrobial Stewardship
    Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.
  • Other: Bacterial culture
    This test identifies the pathogen responsible for an infection.
  • Other: Susceptibility testing
    Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics. Antibiotic susceptibility testing determines the susceptibility of a bacterial strain to a specific antibiotic or a panel of antibiotics.
Study Arms  ICMJE
  • Experimental: Control
    Standard Mayo practices (bacterial culture and susceptibility testing) will be used. FilmArray testing will not be performed.
    Interventions:
    • Other: Bacterial culture
    • Other: Susceptibility testing
  • 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.
    Interventions:
    • Device: FilmArray testing
    • Other: Bacterial culture
    • Other: Susceptibility testing
  • 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.
    Interventions:
    • Device: FilmArray testing
    • Behavioral: Antimicrobial Stewardship
    • Other: Bacterial culture
    • Other: Susceptibility testing
Publications * Banerjee R, Teng CB, Cunningham SA, Ihde SM, Steckelberg JM, Moriarty JP, Shah ND, Mandrekar JN, Patel R. Randomized Trial of Rapid Multiplex Polymerase Chain Reaction-Based Blood Culture Identification and Susceptibility Testing. Clin Infect Dis. 2015 Oct 1;61(7):1071-80. doi: 10.1093/cid/civ447. Epub 2015 Jul 20.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 17, 2016)
743
Original Estimated Enrollment  ICMJE
 (submitted: July 11, 2013)
600
Actual Study Completion Date  ICMJE August 2014
Actual Primary Completion Date August 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 or transitioned to comfort care within 24 hours of enrollment
  • Positive blood culture in prior 7 days
  • Previously enrolled in this study
  • Negative Gram stain
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE up to 99 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01898208
Other Study ID Numbers  ICMJE 11-006920
UM1AI104681 ( U.S. NIH Grant/Contract )
KL2TR000136 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Ritu Banerjee, M.D., Ph.D., Mayo Clinic
Study Sponsor  ICMJE Mayo Clinic
Collaborators  ICMJE
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • National Center for Advancing Translational Science (NCATS)
Investigators  ICMJE
Principal Investigator: Robin Patel, MD Mayo Clinic
Principal Investigator: Ritu Banerjee, MD, Ph.D Mayo Clinic
PRS Account Mayo Clinic
Verification Date February 2016

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP