RAPIDS-GN: Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
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):
-
Standard culture and antimicrobial susceptibility testing (AST); or
-
Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
Condition or Disease | Intervention/Treatment | Phase |
---|---|---|
|
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):
-
Standard culture and antimicrobial susceptibility testing (AST); or
-
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
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
- 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
- Subjects Who Experienced Mortality Within 30 Days of Randomization [Within 30 days of randomization]
Subjects who experienced mortality within 30 days of randomization
- 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.
- ICU Status Through 72 Hours Post-randomization [Within 72 hours of randomization]
ICU status through 72 hours post-randomization
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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
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.- Pro00075768
- 5UM1AI104681
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
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) |
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 |
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. |
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 |
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) |
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) |
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) |
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) |
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) |
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) |
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
|
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
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 |
vance.fowler@duke.edu |
- Pro00075768
- 5UM1AI104681