Bacteremia, Bloodstream Infection, Fungemia
Conditions
Keywords
Bacteremia, Fungemia, Bloodstream infection, susceptibility, MRSA, VRE
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.
Interventions
DEVICEFilmArray 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.
BEHAVIORALAntimicrobial Stewardship
Real time antimicrobial stewardship: an infectious diseases pharmacist or physician will provide patient-specific recommendations to modify antimicrobial therapy.
OTHERBacterial culture
This test identifies the pathogen responsible for an infection.
OTHERSusceptibility 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.
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
National Center for Advancing Translational Sciences (NCATS)
Mayo Clinic
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
No minimum to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Duration of Antimicrobial Therapy (Hours) | 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
| Measure | Time frame | Description |
|---|---|---|
| Time From Positive Gram Stain to First Active Antibiotic | 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 | 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 | 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 | Approximately 14 days after positive blood culture | — |
| Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment | 3 Days after enrollment | — |
| Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment | Approximately within 72 hours of positive blood culture | — |
| Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | 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. |
| Length of Entire Hospitalization (Days) | Participants were followed for the duration of hospital stay, approximately 15 days | — |
| All-cause and Attributable Mortality | 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 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Length of Intensive Care Unit Stay | 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 | 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. |
Countries
United States
Participant flow
Recruitment details
Subjects were recruited at the Mayo Clinic in Rochester, Minnesota from August 2013 to March 2014.
Participants by arm
| Arm | Count |
|---|---|
| Control Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed. | 207 |
| 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. | 198 |
| 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. | 212 |
| Total | 617 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death/comfort care within 24 hours | 10 | 9 | 8 |
| Overall Study | Lost to Follow-up | 3 | 1 | 1 |
| Overall Study | Negative Gram Stain | 6 | 9 | 6 |
| Overall Study | Non-Blood Specimens in Bottles | 3 | 5 | 4 |
| Overall Study | Positive blood culture | 17 | 23 | 15 |
| Overall Study | System/Technical Error | 1 | 2 | 3 |
Baseline characteristics
| Characteristic | Control | FilmArray Test | FilmArray Plus Antimicrobial Stewardship | Total |
|---|---|---|---|---|
| Age, Continuous | 61.5 years STANDARD_DEVIATION 19.32 | 61.4 years STANDARD_DEVIATION 21.22 | 61.2 years STANDARD_DEVIATION 20.08 | 61.4 years STANDARD_DEVIATION 20.17 |
| Region of Enrollment United States | 207 participants | 198 participants | 212 participants | 617 participants |
| Sex: Female, Male Female | 65 Participants | 82 Participants | 85 Participants | 232 Participants |
| Sex: Female, Male Male | 142 Participants | 116 Participants | 127 Participants | 385 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 3 / 207 | 3 / 198 | 2 / 212 |
| serious Total, serious adverse events | 0 / 207 | 0 / 198 | 0 / 212 |
Outcome results
Primary
Duration of Antimicrobial Therapy (Hours)
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.
Time frame: Approximately 4 days after enrollment
Population: Subjects could have received more than one antimicrobial. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship)
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Duration of Antimicrobial Therapy (Hours) | Van, organisms not requiring van (n=56, 56,57) | 8.2 hours |
| Control | Duration of Antimicrobial Therapy (Hours) | Nafcillin, oxacillin, or cefazolin (n=20, 16, 14) | 42 hours |
| Control | Duration of Antimicrobial Therapy (Hours) | Van, Methicillin-susceptible S.aureus(n=13,13,16) | 23 hours |
| Control | Duration of Antimicrobial Therapy (Hours) | Vancomycin (van), all subjects (n=132, 101, 124) | 44 hours |
| Control | Duration of Antimicrobial Therapy (Hours) | Cefepime (n=62, 52, 67 | 55 hours |
| Control | Duration of Antimicrobial Therapy (Hours) | Piperacillin-tazobactam (n=77, 65, 72) | 56 hours |
| Control | Duration of Antimicrobial Therapy (Hours) | Van-susceptible enterococci (n=8, 8, 16) | 20 hours |
| FilmArray Test | Duration of Antimicrobial Therapy (Hours) | Van, Methicillin-susceptible S.aureus(n=13,13,16) | 11 hours |
| FilmArray Test | Duration of Antimicrobial Therapy (Hours) | Vancomycin (van), all subjects (n=132, 101, 124) | 42 hours |
| FilmArray Test | Duration of Antimicrobial Therapy (Hours) | Van, organisms not requiring van (n=56, 56,57) | 0 hours |
| FilmArray Test | Duration of Antimicrobial Therapy (Hours) | Van-susceptible enterococci (n=8, 8, 16) | 70 hours |
| FilmArray Test | Duration of Antimicrobial Therapy (Hours) | Nafcillin, oxacillin, or cefazolin (n=20, 16, 14) | 71 hours |
| FilmArray Test | Duration of Antimicrobial Therapy (Hours) | Piperacillin-tazobactam (n=77, 65, 72) | 44 hours |
| FilmArray Test | Duration of Antimicrobial Therapy (Hours) | Cefepime (n=62, 52, 67 | 71 hours |
| FilmArray Plus Antimicrobial Stewardship | Duration of Antimicrobial Therapy (Hours) | Nafcillin, oxacillin, or cefazolin (n=20, 16, 14) | 85 hours |
| FilmArray Plus Antimicrobial Stewardship | Duration of Antimicrobial Therapy (Hours) | Van, organisms not requiring van (n=56, 56,57) | 0 hours |
| FilmArray Plus Antimicrobial Stewardship | Duration of Antimicrobial Therapy (Hours) | Cefepime (n=62, 52, 67 | 58 hours |
| FilmArray Plus Antimicrobial Stewardship | Duration of Antimicrobial Therapy (Hours) | Piperacillin-tazobactam (n=77, 65, 72) | 45 hours |
| FilmArray Plus Antimicrobial Stewardship | Duration of Antimicrobial Therapy (Hours) | Van, Methicillin-susceptible S.aureus(n=13,13,16) | 8 hours |
| FilmArray Plus Antimicrobial Stewardship | Duration of Antimicrobial Therapy (Hours) | Van-susceptible enterococci (n=8, 8, 16) | 82 hours |
| FilmArray Plus Antimicrobial Stewardship | Duration of Antimicrobial Therapy (Hours) | Vancomycin (van), all subjects (n=132, 101, 124) | 42 hours |
Comparison: For Vancomycin, all patientsp-value: 0.92Kruskal-Wallis
Comparison: For vancomycin, organisms not requiring vancomycin.p-value: 0.032Kruskal-Wallis
Comparison: For vancomycin-susceptible enterococcip-value: 0.037Kruskal-Wallis
Comparison: For vancomycin, methicillin-susceptible Staphylococcus aureus.p-value: 0.2Kruskal-Wallis
Comparison: For nafcillin, oxacillin, or cefazolin.p-value: 0.035Kruskal-Wallis
Comparison: For piperacillin-tazobactam.p-value: 0.012Kruskal-Wallis
Comparison: For cefepime.p-value: 0.56Kruskal-Wallis
Secondary
All-cause and Attributable Mortality
If records of death were incomplete, mortality was determined using Accurint (LexisNexis, Philadelphia, PA), an internet research and location service.
Time frame: 30 days after positive blood culture
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Control | All-cause and Attributable Mortality | All-cause mortality | 22 participants |
| Control | All-cause and Attributable Mortality | Attributable mortality | 7 participants |
| FilmArray Test | All-cause and Attributable Mortality | All-cause mortality | 20 participants |
| FilmArray Test | All-cause and Attributable Mortality | Attributable mortality | 7 participants |
| FilmArray Plus Antimicrobial Stewardship | All-cause and Attributable Mortality | All-cause mortality | 18 participants |
| FilmArray Plus Antimicrobial Stewardship | All-cause and Attributable Mortality | Attributable mortality | 2 participants |
Comparison: Comparison of the 3 groups for all-cause mortality.p-value: 0.74Fisher Exact
Comparison: Comparison of the 3 groups for attributable mortality.p-value: 0.42Fisher Exact
Secondary
Length of Entire Hospitalization (Days)
Time frame: Participants were followed for the duration of hospital stay, approximately 15 days
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Length of Entire Hospitalization (Days) | 8 days |
| FilmArray Test | Length of Entire Hospitalization (Days) | 8 days |
| FilmArray Plus Antimicrobial Stewardship | Length of Entire Hospitalization (Days) | 8 days |
Comparison: This analysis compares the three groups.p-value: 0.6Kruskal-Wallis
Secondary
Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject
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.
Time frame: Approximately 7 days after positive blood culture and for duration of entire hospitalization
Population: The number of subjects analyzed per arm is different than the number of subjects who completed the study because outpatients and a few subjects without final billing data available were excluded.
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Control | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Laboratory Test Cost | 5,377 dollars |
| Control | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Overall Hospitalization Costs | 65,450 dollars |
| Control | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Antimicrobials Costs | 2,194 dollars |
| FilmArray Test | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Laboratory Test Cost | 5,680 dollars |
| FilmArray Test | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Overall Hospitalization Costs | 66,887 dollars |
| FilmArray Test | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Antimicrobials Costs | 1,932 dollars |
| FilmArray Plus Antimicrobial Stewardship | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Overall Hospitalization Costs | 68,729 dollars |
| FilmArray Plus Antimicrobial Stewardship | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Antimicrobials Costs | 1,741 dollars |
| FilmArray Plus Antimicrobial Stewardship | Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject | Laboratory Test Cost | 5,743 dollars |
Comparison: Comparison between the 3 arms for total hospitalization costs.p-value: 0.7789Kruskal-Wallis
Comparison: Comparison between the 3 arms for laboratory test cost.p-value: 0.0006Kruskal-Wallis
Comparison: Comparison between the 3 arms for antimicrobials costs.p-value: 0.654Kruskal-Wallis
Secondary
Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment
Time frame: 3 Days after enrollment
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment | 147 participants |
| FilmArray Test | Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment | 131 participants |
| FilmArray Plus Antimicrobial Stewardship | Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment | 146 participants |
Comparison: This analysis is to compare the three groups.p-value: 0.79Kruskal-Wallis
Secondary
Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events
This included all adverse events that occurred within 2 weeks following enrollment and were documented in the medical record.
Time frame: Approximately 14 days after positive blood culture
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events | 3 participants |
| FilmArray Test | Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events | 3 participants |
| FilmArray Plus Antimicrobial Stewardship | Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events | 2 participants |
Comparison: This analysis is a comparison across all three groups.p-value: 0.82Fisher Exact
Secondary
Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment
Time frame: Approximately within 72 hours of positive blood culture
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment | 49.8 percentage of participants |
| FilmArray Test | Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment | 49 percentage of participants |
| FilmArray Plus Antimicrobial Stewardship | Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment | 45.3 percentage of participants |
Secondary
Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours
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 frame: Within 14 days after positive blood culture
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours | 75 Percentage of blood cultures |
| FilmArray Test | Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours | 89 Percentage of blood cultures |
| FilmArray Plus Antimicrobial Stewardship | Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours | 92 Percentage of blood cultures |
Comparison: This analysis compares the 3 groups.p-value: 0.015Chi-squared
Secondary
Time From Positive Gram Stain to First Active Antibiotic
From positive Gram stain to start of active antibiotic among patients not on active therapy at enrollment; excludes subjects with contaminated blood cultures.
Time frame: Approximately 14 days after positive blood culture
Population: Not all subjects were not on active therapy at enrollment, and also subjects with contaminated blood cultures were excluded. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship): (n=45, 41, 37)
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time From Positive Gram Stain to First Active Antibiotic | 11 hours |
| FilmArray Test | Time From Positive Gram Stain to First Active Antibiotic | 6 hours |
| FilmArray Plus Antimicrobial Stewardship | Time From Positive Gram Stain to First Active Antibiotic | 4 hours |
Comparison: This analysis compares the 3 groups.p-value: 0.55Kruskal-Wallis
Secondary
Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics
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.
Time frame: Positive Gram stain, 96 hours after enrollment
Population: Not all subjects experienced de-escalation or escalation of their antibiotics. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship).
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Control | Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics | Time to first approp. de-escalation(n=121,112,111) | 34 hours |
| Control | Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics | Time to first appropriate escalation (40,38,44) | 24 hours |
| FilmArray Test | Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics | Time to first approp. de-escalation(n=121,112,111) | 38 hours |
| FilmArray Test | Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics | Time to first appropriate escalation (40,38,44) | 6 hours |
| FilmArray Plus Antimicrobial Stewardship | Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics | Time to first approp. de-escalation(n=121,112,111) | 21 hours |
| FilmArray Plus Antimicrobial Stewardship | Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics | Time to first appropriate escalation (40,38,44) | 5 hours |
Comparison: For time to first appropriate de-escalation comparing the 3 groups.p-value: <0.0001Kruskal-Wallis
Comparison: For time to first appropriate escalation comparing the 3 groups.p-value: 0.04Kruskal-Wallis
Secondary
Time to Pathogen Identification
Time frame: Approximately 14 days after positive blood culture
Population: The number of subjects analyzed per arm differs from the number of subjects who completed the study because this outcome measure includes only the subset of subjects who had organisms represented on the rapid multiplex PCR (rmPCR) panel.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Time to Pathogen Identification | 22.3 hours |
| FilmArray Test | Time to Pathogen Identification | 1.3 hours |
| FilmArray Plus Antimicrobial Stewardship | Time to Pathogen Identification | 1.3 hours |
Comparison: This analysis compares the FilmArray test to control arm.p-value: <0.0001Kruskal-Wallis
Comparison: This analysis compares FilmArray plus antimicrobial stewardship to the control arm.p-value: <0.0001Kruskal-Wallis
Other Pre-specified
Length of Intensive Care Unit Stay
Time frame: within 14 days of positive blood culture until ICU discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Control | Length of Intensive Care Unit Stay | 3 days |
| FilmArray Test | Length of Intensive Care Unit Stay | 2 days |
| FilmArray Plus Antimicrobial Stewardship | Length of Intensive Care Unit Stay | 3 days |
p-value: 0.9Kruskal-Wallis
Other Pre-specified
Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment
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.
Time frame: Approximately 30 days after positive blood culture
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Control | Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment | 7.2 percentage of participants |
| FilmArray Test | Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment | 8.1 percentage of participants |
| FilmArray Plus Antimicrobial Stewardship | Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment | 9.9 percentage of participants |
Comparison: This analysis is a comparison of the 3 groups.p-value: 0.62Chi-squared