Bloodstream InfectionNCT03744728
Genotypic Versus Phenotypic Susceptibility Testing of Positive Blood Cultures
A study testing Accelerate PhenoTest™ BC kit in people with Bloodstream Infection, run by Accelerate Diagnostics, Inc. at 1 site in United States.
Trial summary
This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bloodstream Infection
- What is being tested?
- Accelerate PhenoTest™ BC kit
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 774 participants
- Where
- 1 siteUnited States
- Study dates
- 23 May 2019to Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours
- All adult (≥18 years of age)
Who cannot join
- Identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
- Positive blood culture in the prior week with same Gram stain result
- Transferred from an outside hospital and had a history of a previously positive blood culture of the same Gram stain result
- Previously enrolled in the study
- Only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
- Died or were transitioned to comfort care within 24 hours of enrollment
- Negative Gram-stain
- Not admitted to hospital for ≥ 24 hours following blood culture positivity
Trial locations and contacts
1 site in 1 country.
United States1 site
Hennepin County Medical Center
Minneapolis, Minnesota, 55415
About this study
Official title: Randomized Trial of Fast Bacterial Identification and Phenotypic Antimicrobial Susceptibility Testing in Patients With Positive Blood Cultures Using the Accelerate PhenoTest™ BC Kit, Performed on the Accelerate Pheno™ System as Compared With the Verigene® BC-GP/GN
This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Patients will be randomized to one of the following FDA-cleared devices that will be used to assess the workflow impact of fast identification (ID) and antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients: 1) Standard culture and AST of positive blood culture bottles plus the Verigene® Blood Culture Gram-positive/Gram-negative kit (BC-GP/GN); or 2) Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System.
- Conditions
- Bloodstream Infection
- Being tested
- Accelerate PhenoTest™ BC kit, Standard of Care
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerate PhenoTest™ BC kitDiagnostic test
The Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System is a fully-integrated in vitro diagnostic system. It is FDA-cleared to perform ID of bacteria and yeast in less than 90 minutes and AST in less than 7 hours, on average, directly from positive blood culture
Standard of CareDiagnostic test
Also called Verigene® BC-GP/GN
Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN
| Study group | Role | What they receive |
|---|---|---|
| Accelerate Pheno | Active comparator | Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System Receives: Diagnostic Test: Accelerate PhenoTest™ BC kit |
| Standard of Care | Active comparator | Standard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN Receives: Diagnostic Test: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of anti-pseudomonal β-lactam therapy
Mean duration of anti-pseudomonal β-lactam therapy
Measured: 4 days after randomization
Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy
Mean duration of MRSA therapy
Measured: 4 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2018
- Study start23 May 2019
- Primary completionApr 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bloodstream InfectionStudies of the same condition, open and under way.
- 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
- None (open label)
- Enrolment
- 774 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accelerate Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03744728
- Sponsor's protocol ID
- ECP000001
- Status last verified
- Apr 2022
- First submitted
- 15 Nov 2018
- Last updated
- 22 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial of Fast Bacterial Identification and Phenotypic Antimicrobial Susceptibility Testing in Patients With Positive Blood Cultures Using the Accelerate PhenoTest™ BC Kit, Performed on the Accelerate Pheno™ System as Compared With the Verigene® BC-GP/GN
- ClinicalTrials.gov ID
- NCT03744728
- Acronym / sponsor ID
- ECP000001
- Conditions
- Bloodstream Infection
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 774 participants (actual)
- Lead sponsor
- Accelerate Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 23 May 2019 (actual)
- Primary completion
- Apr 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 16 Nov 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is designed as a prospective, randomized, open-label trial evaluating antimicrobial utilization, clinical outcomes, and healthcare costs among patients with positive blood cultures. Patients will be randomized to one of the following FDA-cleared devices that will be used to assess the workflow impact of fast identification (ID) and antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients: 1) Standard culture and AST of positive blood culture bottles plus the Verigene® Blood Culture Gram-positive/Gram-negative kit (BC-GP/GN); or 2) Fast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Accelerate Pheno | Active comparator | Diagnostic Test: Accelerate PhenoTest™ BC kitFast ID and AST of positive blood culture bottles using the Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System |
| Standard of Care | Active comparator | Diagnostic Test: Standard of CareStandard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- All positive blood cultures (including on-panel/off-panel/contaminants) identified during local laboratory business hours
- All adult (≥18 years of age)
Key exclusion criteria (8 listed)
- Identification of blood culture positivity outside of local laboratory business hours (e.g. whenever laboratories are staffed to perform both rapid testing and routine testing)
- Positive blood culture in the prior week with same Gram stain result
- Transferred from an outside hospital and had a history of a previously positive blood culture of the same Gram stain result
- Previously enrolled in the study
- Only the first positive culture for each patient will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
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 kitThe Accelerate PhenoTest™ BC kit with the Accelerate Pheno™ System is a fully-integrated in vitro diagnostic system. It is FDA-cleared to perform ID of bacteria and yeast in less than 90 minutes and AST in less than 7 hours, on average, directly from positive blood culture | Diagnostic test | Accelerate Pheno |
| Standard of CareAlso: Verigene® BC-GP/GNStandard culture and AST of positive blood culture bottles plus the Verigene® BC-GP/GN | Diagnostic test | Standard of Care |
Primary outcome
Duration of anti-pseudomonal β-lactam therapy
Time frame: 4 days after randomization
Mean duration of anti-pseudomonal β-lactam therapy
Duration of anti-methicillin-resistant Staphylococcus aureus (MRSA) therapy
Time frame: 4 days after randomization
Mean duration of MRSA therapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site 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 in people with Bloodstream Infection, run by Accelerate Diagnostics, Inc. at 1 site 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 2 inclusion and 8 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: status not confirmed, as of the sponsor's last update on 22 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Duration of anti-pseudomonal β-lactam therapy (time frame: 4 days after randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 22 Apr 2022.