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Trial record 11 of 764 for:    Anti-Infective Agents AND Antibiotics, Antitubercular AND culture

Rapid Identification and Susceptibility Testing of Pathogens From Blood Cultures

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
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

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Participant);   Primary Purpose: Diagnostic
Conditions Bacteremia
Fungemia
Bloodstream Infection
Interventions Device: FilmArray testing
Behavioral: Antimicrobial Stewardship
Other: Bacterial culture
Other: Susceptibility testing
Enrollment 743
Recruitment Details Subjects were recruited at the Mayo Clinic in Rochester, Minnesota from August 2013 to March 2014.
Pre-assignment Details  
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed. Standard Mayo practices will be used AND FilmArray testing will be performed. Results of the FilmArray Blood Culture Infectious Disease (ID) Panel test will be communicated to the service by phone in real-time, 24 hours a day, 7 days a week. 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.
Period Title: Overall Study
Started 247 247 249
Completed 207 198 212
Not Completed 40 49 37
Reason Not Completed
Positive blood culture             17             23             15
Death/comfort care within 24 hours             10             9             8
Negative Gram Stain             6             9             6
Non-Blood Specimens in Bottles             3             5             4
System/Technical Error             1             2             3
Lost to Follow-up             3             1             1
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship Total
Hide Arm/Group Description Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed. 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. 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. Total of all reporting groups
Overall Number of Baseline Participants 207 198 212 617
Hide Baseline Analysis Population Description
Randomized subjects were excluded if they had a positive blood culture in the prior week, had not provided the state research authorization, previously enrolled in the study, died or transitioned to comfort care within 24 hours of enrollment, or had a negative Gram stain. Only non-excluded subjects were included in the baseline characteristics.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 207 participants 198 participants 212 participants 617 participants
61.5  (19.32) 61.4  (21.22) 61.2  (20.08) 61.4  (20.17)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 207 participants 198 participants 212 participants 617 participants
Female
65
  31.4%
82
  41.4%
85
  40.1%
232
  37.6%
Male
142
  68.6%
116
  58.6%
127
  59.9%
385
  62.4%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 207 participants 198 participants 212 participants 617 participants
207 198 212 617
1.Primary Outcome
Title Duration of Antimicrobial Therapy (Hours)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
Subjects could have received more than one antimicrobial. Participants analyzed per variable below are expressed as (n=control, FilmArray test, and FilmArray+Stewardship)
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Median (Inter-Quartile Range)
Unit of Measure: hours
Vancomycin (van), all subjects (n=132, 101, 124)
44
(22 to 72)
42
(21 to 93)
42
(19 to 90)
Van, organisms not requiring van (n=56, 56,57)
8.2
(0 to 26)
0
(0 to 16)
0
(0 to 3)
Van-susceptible enterococci (n=8, 8, 16)
20
(1 to 59)
70
(48 to 88)
82
(40 to 96)
Van, Methicillin-susceptible S.aureus(n=13,13,16)
23
(20 to 53)
11
(0 to 26)
8
(0 to 44)
Nafcillin, oxacillin, or cefazolin (n=20, 16, 14)
42
(24 to 57)
71
(51 to 79)
85
(42 to 92)
Piperacillin-tazobactam (n=77, 65, 72)
56
(39 to 82)
44
(27 to 74)
45
(19 to 78)
Cefepime (n=62, 52, 67
55
(28 to 96)
71
(43 to 96)
58
(32 to 96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For Vancomycin, all patients
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.92
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For vancomycin, organisms not requiring vancomycin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.032
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For vancomycin-susceptible enterococci
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.037
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For vancomycin, methicillin-susceptible Staphylococcus aureus.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.2
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For nafcillin, oxacillin, or cefazolin.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.035
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 6 Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For piperacillin-tazobactam.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.012
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 7 Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For cefepime.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.56
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
2.Secondary Outcome
Title Time From Positive Gram Stain to First Active Antibiotic
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Median (Inter-Quartile Range)
Unit of Measure: hours
11
(2 to 51)
6
(2 to 31)
4
(2 to 20)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments This analysis compares the 3 groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.55
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
3.Secondary Outcome
Title Time to First Appropriate De-escalation or First Appropriate Escalation of Antibiotics
Time Frame Positive Gram stain, 96 hours after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 247 249
Median (Inter-Quartile Range)
Unit of Measure: hours
Time to first approp. de-escalation(n=121,112,111)
34
(21 to 55)
38
(22 to 66)
21
(7 to 37)
Time to first appropriate escalation (40,38,44)
24
(3 to 67)
6
(2 to 36)
5
(2 to 22)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For time to first appropriate de-escalation comparing the 3 groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments For time to first appropriate escalation comparing the 3 groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.04
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
4.Secondary Outcome
Title Percent of Contaminated Blood Cultures Not Treated or Treated for Less Than 24 Hours
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Measure Type: Number
Unit of Measure: Percentage of blood cultures
75 89 92
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments This analysis compares the 3 groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.015
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
5.Secondary Outcome
Title Time to Pathogen Identification
Hide Description [Not Specified]
Time Frame Approximately 14 days after positive blood culture
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 169 147 165
Median (Inter-Quartile Range)
Unit of Measure: hours
22.3
(17 to 28)
1.3
(0.9 to 1.6)
1.3
(0.9 to 1.6)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test
Comments This analysis compares the FilmArray test to control arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Plus Antimicrobial Stewardship
Comments This analysis compares FilmArray plus antimicrobial stewardship to the control arm.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
6.Secondary Outcome
Title Number of Subjects Who Had Negative Blood Cultures Within 3 Days After Enrollment
Hide Description [Not Specified]
Time Frame 3 Days after enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Measure Type: Number
Unit of Measure: participants
147 131 146
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments This analysis is to compare the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.79
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
7.Secondary Outcome
Title Length of Entire Hospitalization (Days)
Hide Description [Not Specified]
Time Frame Participants were followed for the duration of hospital stay, approximately 15 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Median (Inter-Quartile Range)
Unit of Measure: days
8
(5 to 15)
8
(5 to 15)
8
(5 to 16)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments This analysis compares the three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.60
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
8.Secondary Outcome
Title All-cause and Attributable Mortality
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Measure Type: Number
Unit of Measure: participants
All-cause mortality 22 20 18
Attributable mortality 7 7 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments Comparison of the 3 groups for all-cause mortality.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.74
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments Comparison of the 3 groups for attributable mortality.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.42
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
9.Secondary Outcome
Title Number of Subjects With Antibiotic-Associated Toxicities/Adverse Events
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Measure Type: Number
Unit of Measure: participants
3 3 2
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments This analysis is a comparison across all three groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.82
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
10.Secondary Outcome
Title Percentage of Subjects With Infectious Disease Consultation Within 72 Hours of Enrollment
Hide Description [Not Specified]
Time Frame Approximately within 72 hours of positive blood culture
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Measure Type: Number
Unit of Measure: percentage of participants
49.8 49 45.3
11.Secondary Outcome
Title Mean Total Hospitalization, Laboratory Test, and Antimicrobials Costs Per Subject
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
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/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 191 171 182
Mean (Standard Deviation)
Unit of Measure: dollars
Overall Hospitalization Costs 65,450  (128,686) 66,887  (117,832) 68,729  (134,215)
Laboratory Test Cost 5,377  (10,115) 5,680  (8,872) 5,743  (9,809)
Antimicrobials Costs 2,194  (4,175) 1,932  (3,175) 1,741  (2,748)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments Comparison between the 3 arms for total hospitalization costs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.7789
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments Comparison between the 3 arms for laboratory test cost.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments Comparison between the 3 arms for antimicrobials costs.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.6540
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
12.Other Pre-specified Outcome
Title Length of Intensive Care Unit Stay
Hide Description [Not Specified]
Time Frame within 14 days of positive blood culture until ICU discharge
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Median (Inter-Quartile Range)
Unit of Measure: days
3
(2 to 4)
2
(1 to 5)
3
(2 to 4)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.90
Comments [Not Specified]
Method Kruskal-Wallis
Comments [Not Specified]
13.Other Pre-specified Outcome
Title Percentage of Patients Who Acquired Clostridium Difficile or Multidrug-resistant Organisms Within 30 Days After Enrollment
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description:
Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed.
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.
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.
Overall Number of Participants Analyzed 207 198 212
Measure Type: Number
Unit of Measure: percentage of participants
7.2 8.1 9.9
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Control, FilmArray Test, FilmArray Plus Antimicrobial Stewardship
Comments This analysis is a comparison of the 3 groups.
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.62
Comments [Not Specified]
Method Chi-squared
Comments [Not Specified]
Time Frame [Not Specified]
Adverse Event Reporting Description All events that occurred within 2 weeks following enrollment and were documented in the medical record were collected.
 
Arm/Group Title Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Hide Arm/Group Description Standard Mayo practices (culture and susceptibility testing) will be used. FilmArray testing will not be performed. 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. 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.
All-Cause Mortality
Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/207 (0.00%)      0/198 (0.00%)      0/212 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Control FilmArray Test FilmArray Plus Antimicrobial Stewardship
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/207 (1.45%)      3/198 (1.52%)      2/212 (0.94%)    
Cardiac disorders       
Prolonged QTc interval   0/207 (0.00%)  0 0/198 (0.00%)  0 1/212 (0.47%)  1
Hepatobiliary disorders       
Hepatitis   1/207 (0.48%)  1 0/198 (0.00%)  0 0/212 (0.00%)  0
Immune system disorders       
Myelosuppression   0/207 (0.00%)  0 0/198 (0.00%)  0 1/212 (0.47%)  1
Nervous system disorders       
Seizures   0/207 (0.00%)  0 1/198 (0.51%)  1 0/212 (0.00%)  0
Renal and urinary disorders       
Renal insufficiency   1/207 (0.48%)  1 0/198 (0.00%)  0 0/212 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash   1/207 (0.48%)  1 2/198 (1.01%)  2 0/212 (0.00%)  0
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Ritu Banerjee, M.D., Ph.D.
Organization: Mayo Clinic
Phone: 507-284-6904
EMail: banerjee.ritu@mayo.edu
Layout table for additonal information
Responsible Party: Ritu Banerjee, M.D., Ph.D., Mayo Clinic
ClinicalTrials.gov Identifier: NCT01898208     History of Changes
Other Study ID Numbers: 11-006920
UM1AI104681 ( U.S. NIH Grant/Contract )
KL2TR000136 ( U.S. NIH Grant/Contract )
First Submitted: July 8, 2013
First Posted: July 12, 2013
Results First Submitted: December 2, 2015
Results First Posted: March 15, 2016
Last Update Posted: March 15, 2016