RAPIDS-GN: Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT03218397
Collaborator
National Institute of Allergy and Infectious Diseases (NIAID) (NIH), Vanderbilt University (Other)
500
2
2
13.7
250
18.2

Study Details

Study Description

Brief Summary

RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):

  1. Standard culture and antimicrobial susceptibility testing (AST); or

  2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

Condition or Disease Intervention/Treatment Phase
  • Device: Accelerate PhenoTest™ BC Kit
  • Device: Standard Culture and AST
N/A

Detailed Description

RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):

  1. Standard culture and antimicrobial susceptibility testing (AST); or

  2. Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

Patient specimens with positive blood culture with Gram stain showing GNB identified during local laboratory business hours will be enrolled by the Microbiology Laboratory Technologist if they do not meet any exclusion criteria. Subject specimens will be randomized 1:1 to standard culture and AST or Rapid identification and AST using the FDA approved Accelerate Pheno TM System. Both groups will receive standard antimicrobial stewardship (AS). The primary service, including the prescribing provider, will be unaware of group assignment at the time of randomization, so initial antibiotic choice will not be affected by group assignment. Once rapid results become available and/or AS interventions are made, treating providers may become aware of group assignment.

The goal of this study is to determine the impact of rapid bacterial identification and phenotypic antimicrobial susceptibility testing (AST) on antimicrobial usage and clinical outcomes.

Study Design

Study Type:
Interventional
Actual Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Care Provider)
Masking Description:
Primary service/provider: The primary service, including the prescribing provider, will be unaware of group assignment at the time of randomization, so initial antibiotic choice will not be affected by group assignment. Once rapid results become available and/or AS interventions are made, treating providers may become aware of group assignment.
Primary Purpose:
Diagnostic
Official Title:
Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
Actual Study Start Date :
Oct 9, 2017
Actual Primary Completion Date :
Nov 3, 2018
Actual Study Completion Date :
Nov 30, 2018

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Standard blood culture and AST

Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.

Device: Standard Culture and AST
Standard culture and antimicrobial susceptibility testing (AST)

Active Comparator: Rapid organism identification and AST

Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.

Device: Accelerate PhenoTest™ BC Kit
Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)

Outcome Measures

Primary Outcome Measures

  1. Hours to First Antibiotic Modification [72 hours after randomization]

    Mean hours until first modification of antibiotic therapy within 72 hours post randomization

Secondary Outcome Measures

  1. Subjects Who Experienced Mortality Within 30 Days of Randomization [Within 30 days of randomization]

    Subjects who experienced mortality within 30 days of randomization

  2. Length of Stay in the Hospital [Within 30 days of randomization]

    Length of stay in the hospital after randomization, up to 30 days, for patients alive at 30 days. Length of stay will be date of discharge minus date of randomization.

  3. ICU Status Through 72 Hours Post-randomization [Within 72 hours of randomization]

    ICU status through 72 hours post-randomization

  4. Time to First Antibiotic Escalation [Within 72 hours of randomization]

    Mean hours to first antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.

  5. Time to First Gram-negative Antibiotic Escalation [Within 72 hours of randomization]

    Mean hours to first gram-negative antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.

  6. Time to First Gram-positive Antibiotic Escalation [Within 72 hours of randomization]

    Mean hours to first gram-positive antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.

  7. Time to First Antibiotic De-escalation [Within 72 hours of randomization]

    Mean hours to first antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.

  8. Time to First Gram-negative Antibiotic De-escalation [Within 72 hours of randomization]

    Mean hours to first gram-negative antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.

  9. Time to First Gram-positive Antibiotic De-escalation [Within 72 hours of randomization]

    Mean hours to first gram-positive antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.

  10. Number of Hospital-onset Clostridium Difficile Infections [Within 30 days of randomization]

    Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.

  11. Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days. [Within 30 days of randomization]

    Acquisition of new hospital-acquired infections (HAIs) and/or multidrug resistant organisms (MDROs) within 30 days during index hospitalization identified on routine clinical or surveillance samples. Cultures that will be tracked include the following, from any specimen source, unless otherwise indicated: Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus 3rd generation cephalosporin non-susceptible Enterobacteriaceae Carbapenem-resistant Enterobacteriaceae, as defined by the Centers for Disease Control and Prevention (CDC): resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate possesses a carbapenemase Multidrug-resistant Pseudomonas aeruginosa (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter Candida species (isolated from blood cultures only)

Eligibility Criteria

Criteria

Ages Eligible for Study:
N/A and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.
Exclusion Criteria:
  • Identification of GNB outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)

  • Positive blood culture for GNB at the same institution within prior 7 days (if known at the time of randomization).

  • Deceased at the time of randomization.

  • GNB plus gram-positive organism, gram-negative cocci, and/or yeast detected on Gram stain

  • Previous enrollment in this study

  • No Minnesota research authorization (Rochester site only)

Contacts and Locations

Locations

Site City State Country Postal Code
1 University of California, Los Angeles Los Angeles California United States 90049
2 Mayo Clinic Rochester Minnesota United States 55905

Sponsors and Collaborators

  • Duke University
  • National Institute of Allergy and Infectious Diseases (NIAID)
  • Vanderbilt University

Investigators

  • Study Chair: Ritu Banerjee, MD, PhD, Vanderbilt University Medical Center

Study Documents (Full-Text)

More Information

Publications

None provided.
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03218397
Other Study ID Numbers:
  • Pro00075768
  • 5UM1AI104681
First Posted:
Jul 14, 2017
Last Update Posted:
Nov 26, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Keywords provided by Duke University
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details
Pre-assignment Detail
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Period Title: Overall Study
STARTED 249 251
COMPLETED 226 222
NOT COMPLETED 23 29

Baseline Characteristics

Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST Total
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing. Total of all reporting groups
Overall Participants 226 222 448
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
65.8
(18.3)
62.2
(20.3)
64.0
(19.4)
Sex/Gender, Customized (Count of Participants)
Male
130
57.5%
122
55%
252
56.3%
Female
95
42%
100
45%
195
43.5%
Unknown
1
0.4%
0
0%
1
0.2%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino
13
5.8%
16
7.2%
29
6.5%
Not Hispanic or Latino
202
89.4%
191
86%
393
87.7%
Unknown or Not Reported
11
4.9%
15
6.8%
26
5.8%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native
1
0.4%
1
0.5%
2
0.4%
Asian
10
4.4%
8
3.6%
18
4%
Native Hawaiian or Other Pacific Islander
0
0%
2
0.9%
2
0.4%
Black or African American
9
4%
8
3.6%
17
3.8%
White
183
81%
176
79.3%
359
80.1%
More than one race
2
0.9%
1
0.5%
3
0.7%
Unknown or Not Reported
21
9.3%
26
11.7%
47
10.5%
Region of Enrollment (Count of Participants)
United States
226
100%
222
100%
448
100%

Outcome Measures

1. Primary Outcome
Title Hours to First Antibiotic Modification
Description Mean hours until first modification of antibiotic therapy within 72 hours post randomization
Time Frame 72 hours after randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Mean (Standard Deviation) [hours]
24.7
(24.6)
19.0
(22.9)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.013
Comments alpha = 0.05
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Difference in means
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
1.2 to 10
Parameter Dispersion Type:
Value:
Estimation Comments Difference in mean hours to first antibiotic modification (Standard Blood Culture and AST minus Rapid Organism Identification and AST)
2. Secondary Outcome
Title Subjects Who Experienced Mortality Within 30 Days of Randomization
Description Subjects who experienced mortality within 30 days of randomization
Time Frame Within 30 days of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Dead within 30 days
18
8%
25
11.3%
Not dead within 30 days
206
91.2%
197
88.7%
Unknown
2
0.9%
0
0%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.265
Comments alpha = 0.05
Method Fisher Exact
Comments
3. Secondary Outcome
Title Length of Stay in the Hospital
Description Length of stay in the hospital after randomization, up to 30 days, for patients alive at 30 days. Length of stay will be date of discharge minus date of randomization.
Time Frame Within 30 days of randomization

Outcome Measure Data

Analysis Population Description
Subjects who were alive at 30 days.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 208 197
Mean (Standard Deviation) [days]
8.2
(8.7)
9.8
(9.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.093
Comments alpha = 0.05
Method t-test, 2 sided
Comments T-test for the difference in mean length of stay (days) between treatment arms among subjects alive at 30 days.
4. Secondary Outcome
Title ICU Status Through 72 Hours Post-randomization
Description ICU status through 72 hours post-randomization
Time Frame Within 72 hours of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
In ICU < 72 hours after randomization
33
14.6%
55
24.8%
In ICU for >= 72 hours after randomization
34
15%
37
16.7%
Not in ICU
159
70.4%
130
58.6%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.014
Comments alpha = 0.05
Method Fisher Exact
Comments
5. Secondary Outcome
Title Time to First Antibiotic Escalation
Description Mean hours to first antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time Frame Within 72 hours of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Mean (Standard Deviation) [hours]
52.7
(28.8)
45.2
(31.4)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.009
Comments alpha = 0.05
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Difference in means
Estimated Value 7.5
Confidence Interval (2-Sided) 95%
1.9 to 13.1
Parameter Dispersion Type:
Value:
Estimation Comments Difference in mean hours to first antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)
6. Secondary Outcome
Title Time to First Gram-negative Antibiotic Escalation
Description Mean hours to first gram-negative antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time Frame Within 72 hours of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Mean (Standard Deviation) [hours]
53.9
(28.4)
47.5
(31.2)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.022
Comments alpha = 0.05
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Difference in means
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
0.9 to 12.0
Parameter Dispersion Type:
Value:
Estimation Comments Difference in mean hours to first gram-negative antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)
7. Secondary Outcome
Title Time to First Gram-positive Antibiotic Escalation
Description Mean hours to first gram-positive antibiotic escalation within 72 hours from randomization, where escalation is defined as changing to a broader spectrum antibiotic, addition of one or more antibiotics, or conversion of oral to intravenous route.
Time Frame Within 72 hours of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Mean (Standard Deviation) [hours]
70.5
(9.5)
69.7
(11.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.46
Comments alpha = 0.05
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Difference in means
Estimated Value 0.7
Confidence Interval (2-Sided) 95%
-1.2 to 2.7
Parameter Dispersion Type:
Value:
Estimation Comments Difference in mean hours to first gram-positive antibiotic escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)
8. Secondary Outcome
Title Time to First Antibiotic De-escalation
Description Mean hours to first antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time Frame Within 72 hours of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Mean (Standard Deviation) [hours]
44.2
(26.2)
39.6
(28.0)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.074
Comments alpha = 0.05
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Difference in means
Estimated Value 4.6
Confidence Interval (2-Sided) 95%
-0.4 to 9.6
Parameter Dispersion Type:
Value:
Estimation Comments Difference in mean hours to first antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)
9. Secondary Outcome
Title Time to First Gram-negative Antibiotic De-escalation
Description Mean hours to first gram-negative antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time Frame Within 72 hours of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Mean (Standard Deviation) [hours]
55.8
(23.5)
49.3
(27.8)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.008
Comments alpha = 0.05
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Difference in means
Estimated Value 6.5
Confidence Interval (2-Sided) 95%
1.7 to 11.2
Parameter Dispersion Type:
Value:
Estimation Comments Difference in mean hours to first gram-negative antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)
10. Secondary Outcome
Title Time to First Gram-positive Antibiotic De-escalation
Description Mean hours to first gram-positive antibiotic de-escalation within 72 hours from randomization, where de-escalation is defined as changing to a narrower spectrum antibiotic, cessation of one or more antibiotics, or changing from an intravenous to oral route of appropriate drug.
Time Frame Within 72 hours of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Mean (Standard Deviation) [hours]
60.4
(22.6)
62.2
(21.3)
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Standard Blood Culture and AST, Rapid Organism Identification and AST
Comments
Type of Statistical Test Superiority
Comments
Statistical Test of Hypothesis p-Value 0.37
Comments alpha = 0.05
Method t-test, 2 sided
Comments
Method of Estimation Estimation Parameter Difference in means
Estimated Value -1.9
Confidence Interval (2-Sided) 95%
-5.9 to 2.2
Parameter Dispersion Type:
Value:
Estimation Comments Difference in mean hours to first gram-positive antibiotic de-escalation (Standard Blood Culture and AST minus Rapid Organism Identification and AST)
11. Secondary Outcome
Title Number of Hospital-onset Clostridium Difficile Infections
Description Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.
Time Frame Within 30 days of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Number (95% Confidence Interval) [Infections per 10,000 patient-days]
26.8
27.5
12. Secondary Outcome
Title Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.
Description Acquisition of new hospital-acquired infections (HAIs) and/or multidrug resistant organisms (MDROs) within 30 days during index hospitalization identified on routine clinical or surveillance samples. Cultures that will be tracked include the following, from any specimen source, unless otherwise indicated: Methicillin-resistant Staphylococcus aureus Vancomycin-resistant Enterococcus 3rd generation cephalosporin non-susceptible Enterobacteriaceae Carbapenem-resistant Enterobacteriaceae, as defined by the Centers for Disease Control and Prevention (CDC): resistant to imipenem, meropenem, doripenem, or ertapenem OR documentation that the isolate possesses a carbapenemase Multidrug-resistant Pseudomonas aeruginosa (resistant to aminoglycosides, cephalosporins, fluoroquinolones, and carbapenems) Carbapenem-resistant Acinetobacter Candida species (isolated from blood cultures only)
Time Frame Within 30 days of randomization

Outcome Measure Data

Analysis Population Description
Subjects who completed the study.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
Measure Participants 226 222
Number (95% Confidence Interval) [Infections per 10,000 patient-days]
123.3
105.5

Adverse Events

Time Frame 30 days from randomization
Adverse Event Reporting Description With the exception of mortality, adverse events were not collected.
Arm/Group Title Standard Blood Culture and AST Rapid Organism Identification and AST
Arm/Group Description Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Rapid organism identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX), and antimicrobial stewardship. The blood sample will also undergo standard culture and AST in addition to the rapid testing.
All Cause Mortality
Standard Blood Culture and AST Rapid Organism Identification and AST
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 18/226 (8%) 25/222 (11.3%)
Serious Adverse Events
Standard Blood Culture and AST Rapid Organism Identification and AST
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)
Other (Not Including Serious) Adverse Events
Standard Blood Culture and AST Rapid Organism Identification and AST
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/0 (NaN) 0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Vance Fowler, MD, MHS
Organization Duke University
Phone 919-613-5678
Email vance.fowler@duke.edu
Responsible Party:
Duke University
ClinicalTrials.gov Identifier:
NCT03218397
Other Study ID Numbers:
  • Pro00075768
  • 5UM1AI104681
First Posted:
Jul 14, 2017
Last Update Posted:
Nov 26, 2019
Last Verified:
Nov 1, 2019