Gram-negative BacteremiaRAPIDS-GNNCT03218397
Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia
A study testing Accelerate PhenoTest™ BC Kit and Standard Culture and AST in people with Gram-negative Bacteremia, run by Duke University at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Gram-negative Bacteremia
- What is being tested?
- Accelerate PhenoTest™ BC Kit and Standard Culture and AST
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 500 participants
- Where
- 2 sitesUnited States
- Study dates
- 9 Oct 2017to 30 Nov 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of California, Los Angeles
Los Angeles, California, 90049
Mayo Clinic
Rochester, Minnesota, 55905
About this study
Official title: Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
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)
Read the 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.
- Conditions
- Gram-negative Bacteremia
- Being tested
- Accelerate PhenoTest™ BC Kit, Standard Culture and AST
- Keywords
- Gram-negative Bacteremia, ICU, Critically ill, Intensive Care Unit, Rapid identification, Rapid susceptibility, Accelerate PhenoTest™ BC Kit, Accelerate Pheno™ System (AXDX), Antimicrobial stewardship, Antimicrobial use
- Medical subject headings
- Critical Illness
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerate PhenoTest™ BC KitDevice
Rapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX)
Standard Culture and ASTDevice
Standard culture and antimicrobial susceptibility testing (AST)
| Study group | Role | What they receive |
|---|---|---|
| Standard blood culture and AST | Active comparator | Standard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. Receives: Device: Standard Culture and AST |
| 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. Receives: Device: Accelerate PhenoTest™ BC Kit |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hours to First Antibiotic Modification
Mean hours until first modification of antibiotic therapy within 72 hours post randomization
Measured: 72 hours after randomization
Secondary outcomes (11)
Subjects Who Experienced Mortality Within 30 Days of Randomization
Subjects who experienced mortality within 30 days of randomization
Measured: 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.
Measured: Within 30 days of randomization
ICU Status Through 72 Hours Post-randomization
ICU status through 72 hours post-randomization
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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)
Measured: Within 30 days of randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jul 2017
- Study start9 Oct 2017
- Primary completion3 Nov 2018
- Study completion30 Nov 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gram-negative BacteremiaStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 500 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Vanderbilt University
- Responsible party
- Sponsor
- Investigators
- Ritu Banerjee, MD, PhD, Study chair, Vanderbilt University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03218397
- Sponsor's protocol ID
- Pro00075768
- Other IDs
- 5UM1AI104681
- Acronym
- RAPIDS-GN
- Status last verified
- Nov 2019
- First submitted
- 11 Jul 2017
- Last updated
- 26 Nov 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 32374822
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Identification and Phenotypic Susceptibility Testing for Gram-Negative Bacteremia (RAPIDS-GN)
- ClinicalTrials.gov ID
- NCT03218397
- Acronym / sponsor ID
- RAPIDS-GN / Pro00075768
- Conditions
- Gram-negative Bacteremia
- Keywords
- Gram-negative Bacteremia, ICU, Critically ill, Intensive Care Unit, Rapid identification, Rapid susceptibility, Accelerate PhenoTest™ BC Kit, Accelerate Pheno™ System (AXDX)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 500 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- National Institute of Allergy and Infectious Diseases (NIAID), Vanderbilt University
- Study start
- 9 Oct 2017 (actual)
- Primary completion
- 3 Nov 2018 (actual)
- Study completion
- 30 Nov 2018 (actual)
- First posted
- 14 Jul 2017 (actual)
- Results
- Posted 26 Nov 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard blood culture and AST | Active comparator | Device: Standard Culture and ASTStandard blood culture and antimicrobial susceptibility testing (AST), and antimicrobial stewardship. |
| Rapid organism identification and AST | Active comparator | Device: Accelerate PhenoTest™ BC KitRapid 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Positive blood culture with Gram stain showing GNB identified during local laboratory business hours.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Accelerate PhenoTest™ BC KitRapid identification and AST using the Accelerate PhenoTest™ BC Kit, performed on the Accelerate Pheno™ System (AXDX) | Device | Rapid organism identification and AST |
| Standard Culture and ASTStandard culture and antimicrobial susceptibility testing (AST) | Device | Standard blood culture and AST |
Primary outcome
Hours to First Antibiotic Modification
Time frame: 72 hours after randomization
Mean hours until first modification of antibiotic therapy within 72 hours post randomization
11 secondary outcomes
Subjects Who Experienced Mortality Within 30 Days of Randomization
Time frame: Within 30 days of randomization
Length of Stay in the Hospital
Time frame: Within 30 days of randomization
ICU Status Through 72 Hours Post-randomization
Time frame: Within 72 hours of randomization
Time to First Antibiotic Escalation
Time frame: Within 72 hours of randomization
Time to First Gram-negative Antibiotic Escalation
Time frame: Within 72 hours of randomization
Time to First Gram-positive Antibiotic Escalation
Time frame: Within 72 hours of randomization
Time to First Antibiotic De-escalation
Time frame: Within 72 hours of randomization
Time to First Gram-negative Antibiotic De-escalation
Time frame: Within 72 hours of randomization
Time to First Gram-positive Antibiotic De-escalation
Time frame: Within 72 hours of randomization
Number of Hospital-onset Clostridium Difficile Infections
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.
Time frame: Within 30 days of randomization
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 32374822Banerjee 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ritu Banerjee, MD, PhD study chair
Vanderbilt University Medical Center
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerate PhenoTest™ BC Kit and Standard Culture and AST in people with Gram-negative Bacteremia, run by Duke University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Nov 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hours to First Antibiotic Modification (time frame: 72 hours after randomization). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03218397, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.