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OpenTrials
Completed

NCT Number: NCT01898208

Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

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)?

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Key information

Age range

Up to 99 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

FilmArray testing

Device

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: FilmArray Blood Culture Identification Panel

Antimicrobial stewardship

Behavioral

Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.

Bacterial culture

Other

This test identifies the pathogen responsible for an infection.

Susceptibility testing

Other

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. Time to Pathogen Identification

    Time frame: Approximately 14 days after positive blood culture

  5. Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment

    Time frame: 3 Days after enrollment

  6. Length of Entire Hospitalization (Days)

    Time frame: Participants were followed for the duration of hospital stay, approximately 15 days

  7. 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.

  8. 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.

  9. Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment

    Time frame: Approximately within 72 hours of positive blood culture

  10. 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.

Other outcomes

  1. Length of Intensive Care Unit Stay

    Time frame: within 14 days of positive blood culture until ICU discharge

  2. 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.

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Collaborators

  • National Center for Advancing Translational Sciences (NCATS)
  • National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Official study title

Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles - A Quality Improvement Theragnostic Stewardship Project

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 12, 2013
Registry last updated
Mar 15, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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