- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01898208
Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures
February 17, 2016 updated by: Ritu Banerjee, M.D., Ph.D., Mayo Clinic
Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles - A Quality Improvement Theragnostic Stewardship Project
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)?
Study Overview
Status
Completed
Conditions
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
Interventional
Enrollment (Actual)
743
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Rochester, Minnesota, United States, 55905
- Mayo Clinic in Rochester
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 99 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Control
Standard Mayo practices (bacterial culture and susceptibility testing) will be used.
FilmArray testing will not be performed.
|
This test identifies the pathogen responsible for an infection.
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.
|
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.
|
This test identifies the pathogen responsible for an infection.
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.
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 Names:
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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.
|
This test identifies the pathogen responsible for an infection.
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.
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 Names:
Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Duration of Antimicrobial Therapy (Hours)
Time Frame: Approximately 4 days after enrollment
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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.
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Approximately 4 days after enrollment
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Time From Positive Gram Stain to First Active Antibiotic
Time Frame: Approximately 14 days after positive blood culture
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From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.
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Approximately 14 days after positive blood culture
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Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics
Time Frame: Positive Gram stain, 96 hours after enrollment
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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.
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Positive Gram stain, 96 hours after enrollment
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Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours
Time Frame: Within 14 days after positive blood culture
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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.
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Within 14 days after positive blood culture
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Time to Pathogen Identification
Time Frame: Approximately 14 days after positive blood culture
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Approximately 14 days after positive blood culture
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Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment
Time Frame: 3 Days after enrollment
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3 Days after enrollment
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Length of Entire Hospitalization (Days)
Time Frame: Participants were followed for the duration of hospital stay, approximately 15 days
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Participants were followed for the duration of hospital stay, approximately 15 days
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All-cause and Attributable Mortality
Time Frame: 30 days after positive blood culture
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If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.
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30 days after positive blood culture
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Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events
Time Frame: Approximately 14 days after positive blood culture
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This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.
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Approximately 14 days after positive blood culture
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Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment
Time Frame: Approximately within 72 hours of positive blood culture
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Approximately within 72 hours of positive blood culture
|
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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
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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.
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Approximately 7 days after positive blood culture and for duration of entire hospitalization
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Length of Intensive Care Unit Stay
Time Frame: within 14 days of positive blood culture until ICU discharge
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within 14 days of positive blood culture until ICU discharge
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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
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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.
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Approximately 30 days after positive blood culture
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Robin Patel, MD, Mayo Clinic
- Principal Investigator: Ritu Banerjee, MD, Ph.D, Mayo Clinic
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
August 1, 2013
Primary Completion (Actual)
August 1, 2014
Study Completion (Actual)
August 1, 2014
Study Registration Dates
First Submitted
July 8, 2013
First Submitted That Met QC Criteria
July 11, 2013
First Posted (Estimate)
July 12, 2013
Study Record Updates
Last Update Posted (Estimate)
March 15, 2016
Last Update Submitted That Met QC Criteria
February 17, 2016
Last Verified
February 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11-006920
- UM1AI104681 (U.S. NIH Grant/Contract)
- KL2TR000136 (NIH)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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