Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| 5UM1AI104681 | U.S. NIH Grant/Contract | View source |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
| Vanderbilt University | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard blood culture and AST | Active Comparator | Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. |
|
| Rapid organism identification and AST | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerate PhenoTest™ BC Kit | Device | Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hours to First Antibiotic Modification | Mean hours until first modification of antibiotic therapy within 72 hours post randomization | 72 hours after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| Subjects Who Experienced Mortality Within 30 Days of Randomization | Subjects who experienced mortality within 30 days of randomization | Within 30 days of randomization |
| Length of Stay in the Hospital |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Ritu Banerjee, MD, PhD | Vanderbilt University Medical Center | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Los Angeles | Los Angeles | California | 90049 | United States | ||
| Mayo Clinic |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32374822 | Derived | Banerjee R, Komarow L, Virk A, Rajapakse N, Schuetz AN, Dylla B, Earley M, Lok J, Kohner P, Ihde S, Cole N, Hines L, Reed K, Garner OB, Chandrasekaran S, de St Maurice A, Kanatani M, Curello J, Arias R, Swearingen W, Doernberg SB, Patel R. Randomized Trial Evaluating Clinical Impact of RAPid IDentification and Susceptibility Testing for Gram-negative Bacteremia: RAPIDS-GN. Clin Infect Dis. 2021 Jul 1;73(1):e39-e46. doi: 10.1093/cid/ciaa528. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Standard Blood Culture and AST | Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Subjects who completed the study.
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Standard Blood Culture and AST | Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. |
| BG001 | Rapid Organism Identification and AST |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Hours to First Antibiotic Modification | Mean hours until first modification of antibiotic therapy within 72 hours post randomization | Subjects who completed the study. | Posted | Mean | Standard Deviation | hours | 72 hours after randomization |
|
30 days from randomization
With the exception of mortality, adverse events were not collected.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Standard Blood Culture and AST | Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Vance Fowler, MD, MHS | Duke University | 919-613-5678 | vance.fowler@duke.edu |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 30, 2018 | Oct 9, 2019 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D016638 | Critical Illness |
| ID | Term |
|---|---|
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
Not provided
Not provided
Not provided
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.
| Standard Culture and AST | Device | Standard culture and antimicrobial susceptibility testing (AST) |
|
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.
| Within 30 days of randomization |
| ICU Status Through 72 Hours Post-randomization | ICU status through 72 hours post-randomization | 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. | 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. | 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. | 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. | 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. | 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. | 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. | 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:
| Within 30 days of randomization |
| Rochester |
| Minnesota |
| 55905 |
| United States |
| Comfort care and positive blood culture |
|
| Comfort care and mixed culture |
|
| Mixed culture |
|
| Inaccessible hospital records |
|
| No gram-negative bacilli (GNB) |
|
| Randomized during laboratory off hours |
|
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.
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex/Gender, Customized | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Subjects Who Experienced Mortality Within 30 Days of Randomization | Subjects who experienced mortality within 30 days of randomization | Subjects who completed the study. | Posted | Count of Participants | Participants | Within 30 days of randomization |
|
|
|
|
| Secondary | 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. | Subjects who were alive at 30 days. | Posted | Mean | Standard Deviation | days | Within 30 days of randomization |
|
|
|
|
| Secondary | ICU Status Through 72 Hours Post-randomization | ICU status through 72 hours post-randomization | Subjects who completed the study. | Posted | Count of Participants | Participants | Within 72 hours of randomization |
|
|
|
|
| Secondary | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | hours | Within 72 hours of randomization |
|
|
|
|
| Secondary | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | hours | Within 72 hours of randomization |
|
|
|
|
| Secondary | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | hours | Within 72 hours of randomization |
|
|
|
|
| Secondary | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | hours | Within 72 hours of randomization |
|
|
|
|
| Secondary | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | hours | Within 72 hours of randomization |
|
|
|
|
| Secondary | 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. | Subjects who completed the study. | Posted | Mean | Standard Deviation | hours | Within 72 hours of randomization |
|
|
|
|
| Secondary | 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. | Subjects who completed the study. | Posted | Number | 95% Confidence Interval | Infections per 10,000 patient-days | Within 30 days of randomization |
|
|
|
| Secondary | 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:
| Subjects who completed the study. | Posted | Number | 95% Confidence Interval | Infections per 10,000 patient-days | Within 30 days of randomization |
|
|
|
| 18 |
| 226 |
| 0 |
| 0 |
| 0 |
| 0 |
| EG001 | 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. | 25 | 222 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
| Unknown |
|
| Not in ICU |
|