Clinical trial NCT01898208: Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures
Official title: Rapid Identification and Susceptibility Testing of Pathogens Growing in Blood Culture Bottles - A Quality Improvement Theragnostic Stewardship Project
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bacteremia
Fungemia
Bloodstream Infection
Keywords: Bacteremia
Fungemia
Bloodstream infection
susceptibility
MRSA
VRE
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: National Institute of Allergy and Infectious Diseases (NIAID)
name: National Center for Advancing Translational Sciences (NCATS)
First posted: 2013-07-12
Enrollment: 743
Sex: ALL
Maximum age (years): 99
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility 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 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

Primary outcomes:
measure: Duration of Antimicrobial Therapy (Hours)
timeFrame: Approximately 4 days after enrollment
Secondary outcomes:
measure: Time From Positive Gram Stain to First Active Antibiotic
timeFrame: Approximately 14 days after positive blood culture
measure: Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics
timeFrame: Positive Gram stain, 96 hours after enrollment
measure: Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours
timeFrame: Within 14 days after positive blood culture
measure: Time to Pathogen Identification
timeFrame: Approximately 14 days after positive blood culture
measure: Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment
timeFrame: 3 Days after enrollment
measure: Length of Entire Hospitalization (Days)
timeFrame: Participants were followed for the duration of hospital stay, approximately 15 days
measure: All-cause and Attributable Mortality
timeFrame: 30 days after positive blood culture
measure: Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events
timeFrame: Approximately 14 days after positive blood culture
measure: Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment
timeFrame: Approximately within 72 hours of positive blood culture
measure: Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject
timeFrame: Approximately 7 days after positive blood culture and for duration of entire hospitalization
Other outcomes:
measure: Length of Intensive Care Unit Stay
timeFrame: within 14 days of positive blood culture until ICU discharge
measure: Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment
timeFrame: Approximately 30 days after positive blood culture
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Robin Patel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Mayo Clinic
name: Ritu Banerjee, MD, Ph.D
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.