An interventional study of Accelerate PhenoTest™ BC Kit and Standard Culture and AST in Gram-negative Bacteremia, sponsored by Duke University. Completed at 2 sites in United States. Per ClinicalTrials.gov, last updated 2019-11-26.
Sponsored by Duke University · Not applicable, Interventional, and Diagnostic
RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):
RAPIDS-GN is a multi-center, prospective, randomized, controlled trial to evaluate the following strategies for patients with confirmed gram-negative bacillus bacteremia (GNB):
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.
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Exclusion Criteria:
Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship.
Device: Standard Culture 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)
Standard culture and antimicrobial susceptibility testing (AST)
Hours to First Antibiotic Modification
Mean hours until first modification of antibiotic therapy within 72 hours post randomization
Time frame: 72 hours after randomization
Subjects Who Experienced Mortality Within 30 Days of Randomization
Subjects who experienced mortality within 30 days of randomization
Time frame: Within 30 days of randomization
Length of Stay in the Hospital
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
ICU Status Through 72 Hours Post-randomization
ICU status through 72 hours post-randomization
Time frame: Within 72 hours of randomization
Time to First Antibiotic Escalation
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
Time to First Gram-negative Antibiotic Escalation
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
Time to First Gram-positive Antibiotic Escalation
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
Time to First Antibiotic De-escalation
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
Time to First Gram-negative Antibiotic De-escalation
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
Time to First Gram-positive Antibiotic De-escalation
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
Number of Hospital-onset Clostridium Difficile Infections
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
Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days.
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
| Milestone | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Started | 249 | 251 |
| Completed | 226 | 222 |
| Not completed | 23 | 29 |
| Withdrew: Prior positive blood culture | 8 | 13 |
| Withdrew: Comfort care | 8 | 5 |
| Withdrew: Comfort care and positive blood culture | 1 | 0 |
| Withdrew: Comfort care and mixed culture | 0 | 1 |
| Withdrew: Mixed culture | 2 | 2 |
| Withdrew: Inaccessible hospital records | 2 | 5 |
| Withdrew: No gram-negative bacilli (gnb) | 0 | 2 |
| Withdrew: Randomized during laboratory off hours | 2 | 1 |
Mean hours until first modification of antibiotic therapy within 72 hours post randomization
| hours | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Hours to First Antibiotic Modification | 24.7 ± 24.6 | 19.0 ± 22.9 |
Subjects who experienced mortality within 30 days of randomization
| Participants | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Dead within 30 days | 18 | 25 |
| Not dead within 30 days | 206 | 197 |
| Unknown | 2 | 0 |
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.
| days | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Length of Stay in the Hospital | 8.2 ± 8.7 | 9.8 ± 9.8 |
ICU status through 72 hours post-randomization
| Participants | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| In ICU < 72 hours after randomization | 33 | 55 |
| In ICU for >= 72 hours after randomization | 34 | 37 |
| Not in ICU | 159 | 130 |
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.
| hours | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Time to First Antibiotic Escalation | 52.7 ± 28.8 | 45.2 ± 31.4 |
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.
| hours | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Time to First Gram-negative Antibiotic Escalation | 53.9 ± 28.4 | 47.5 ± 31.2 |
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.
| hours | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Time to First Gram-positive Antibiotic Escalation | 70.5 ± 9.5 | 69.7 ± 11.3 |
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.
| hours | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Time to First Antibiotic De-escalation | 44.2 ± 26.2 | 39.6 ± 28.0 |
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.
| hours | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Time to First Gram-negative Antibiotic De-escalation | 55.8 ± 23.5 | 49.3 ± 27.8 |
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.
| hours | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Time to First Gram-positive Antibiotic De-escalation | 60.4 ± 22.6 | 62.2 ± 21.3 |
Acquisition of hospital-onset Clostridium difficile within 30 days, as defined by the National Healthcare Safety Network (NHSN), normalized to 10,000 patient-days.
| Infections per 10,000 patient-days | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Number of Hospital-onset Clostridium Difficile Infections | 26.8 (11.2 to 64.4) | 27.5 (12.4 to 61.3) |
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)
| Infections per 10,000 patient-days | Standard Blood Culture and AST | Rapid Organism Identification and AST |
|---|---|---|
| Number of New Hospital-acquired Infections (HAIs) and/or Multidrug Resistant Organisms (MDROs), Normalized to 10,000 Patient-days. | 123.3 (82.0 to 185.6) | 105.5 (70.1 to 158.8) |
Collected over 30 days from randomization. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Standard Blood Culture and AST | 18/226 (8%) | — | — |
| Rapid Organism Identification and AST | 25/222 (11.3%) | — | — |
Subjects who completed the study.
| Age, Continuous(years) | Standard Blood Culture and AST | Rapid Organism Identification and AST | Total |
|---|---|---|---|
| Mean | 65.8 ± 18.3 | 62.2 ± 20.3 | 64.0 ± 19.4 |
| Sex/Gender, Customized(Participants) | Standard Blood Culture and AST | Rapid Organism Identification and AST | Total |
|---|---|---|---|
| Male | 130 | 122 | 252 |
| Female | 95 | 100 | 195 |
| Unknown | 1 | 0 | 1 |
| Ethnicity (NIH/OMB)(Participants) | Standard Blood Culture and AST | Rapid Organism Identification and AST | Total |
|---|---|---|---|
| Hispanic or Latino | 13 | 16 | 29 |
| Not Hispanic or Latino | 202 | 191 | 393 |
| Unknown or Not Reported | 11 | 15 | 26 |
| Race (NIH/OMB)(Participants) | Standard Blood Culture and AST | Rapid Organism Identification and AST | Total |
|---|---|---|---|
| American Indian or Alaska Native | 1 | 1 | 2 |
| Asian | 10 | 8 | 18 |
| Native Hawaiian or Other Pacific Islander | 0 | 2 | 2 |
| Black or African American | 9 | 8 | 17 |
| White | 183 | 176 | 359 |
| More than one race | 2 | 1 | 3 |
| Unknown or Not Reported | 21 | 26 | 47 |
| Region of Enrollment(Participants) | Standard Blood Culture and AST | Rapid Organism Identification and AST | Total |
|---|---|---|---|
| United States | 226 | 222 | 448 |
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