Gram-negative BacteremiaNCT03745014
Clinical Impact of Fast Phenotypic Antimicrobial Susceptibility Testing on Patients With Gram-Negative Rod Bacteremia
A study testing Accelerate Pheno in people with Gram-negative Bacteremia, run by Accelerate Diagnostics, Inc..
Trial summary
The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Gram-negative Bacteremia
- What is being tested?
- Accelerate Pheno
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- 30 Sep 2019to 31 Aug 2020
- 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
- Adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on Gram stain)
- Blood culture drawn in the Emergency Department (ED)
Who cannot join
- Patients not admitted to hospital
- Patients discharged from hospital prior to blood culture positivity
- Only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
- Positive blood culture with GNR in the prior 7 days (if known at the time of randomization)
- Transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization)
- GNR plus gram-positive organism, gram-negative cocci, and/or yeast detected on blood culture Gram stain
- Deceased or palliative care at the time of randomization
- Patient who is moribund (does not survive the initial 72 hours after enrollment)
About this study
Official title: Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Due to Gram-Negative Rods
The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.
- Conditions
- Gram-negative Bacteremia
- Being tested
- Accelerate Pheno, Standard of Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Accelerate PhenoDiagnostic test
The Accelerate Pheno™ system and PhenoTest™ BC Kit 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
Standard blood culture work up as determined by the site's microbiology lab.
| Study group | Role | What they receive |
|---|---|---|
| Pheno | Active comparator | Not described Receives: Diagnostic Test: Accelerate Pheno |
| Standard of Care | Active comparator | Not described Receives: Diagnostic Test: Standard of Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Desirability of Outcome Ranking (DOOR) - composite outcome
The primary endpoint is the probability that a patient will have a better DOOR when the Accelerate PhenoTest™ BC kit is used on positive blood cultures due to gram-negative rods compared to the standard of care
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2018
- Study start30 Sep 2019 (estimated)
- Primary completion30 Jun 2020 (estimated)
- Study completion31 Aug 2020 (estimated)
Why it stopped: No sites identified with IRB approval
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gram-negative BacteremiaStudies 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
- 0 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
- NCT03745014
- Sponsor's protocol ID
- ECP000002
- Status last verified
- Apr 2020
- First submitted
- 15 Nov 2018
- Last updated
- 14 Apr 2020
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Assessing the Clinical Impact of Fast Bacteria Identification and Phenotypic Antimicrobial Susceptibility Testing on Patients With Bacteremic Due to Gram-Negative Rods
- ClinicalTrials.gov ID
- NCT03745014
- Acronym / sponsor ID
- ECP000002
- Conditions
- Gram-negative Bacteremia
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: No sites identified with IRB approval
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Accelerate Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Sep 2019 (estimated)
- Primary completion
- 30 Jun 2020 (estimated)
- Study completion
- 31 Aug 2020 (estimated)
- First posted
- 19 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.
The FDA-cleared Accelerate Pheno™ System and PhenoTest™ Blood Culture (BC) Kit will be used to assess the workflow impact of fast identification (ID)/ antimicrobial susceptibility testing (AST) in the microbiology lab and in the quality of care in patients with Gram-negative rod (GNR) bacteremia. Blood culture work up will be randomized to one of two arms: the positive blood culture will either undergo fast ID and AST using the Accelerate Pheno™ System and PhenoTest™ BC Kit or processing per the site's standard of care (SOC) procedures.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pheno | Active comparator | Diagnostic Test: Accelerate Pheno |
| Standard of Care | Active comparator | Diagnostic Test: Standard of Care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Adult (≥18 years of age) hospitalized patients with positive blood culture due to gram-negative rod (on Gram stain)
- Blood culture drawn in the Emergency Department (ED)
Key exclusion criteria (8 listed)
- Patients not admitted to hospital
- Patients discharged from hospital prior to blood culture positivity
- Only the first positive blood culture for each patient of each hospitalization will be included during the study period; any subsequent episode of bloodstream infection (BSI) will be excluded
- Positive blood culture with GNR in the prior 7 days (if known at the time of randomization)
- Transferred from an outside hospital and had a history of a previously positive blood culture of the same organism in the prior 7 days (if known at the time of randomization)
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 PhenoThe Accelerate Pheno™ system and PhenoTest™ BC Kit 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 | Pheno |
| Standard of CareStandard blood culture work up as determined by the site's microbiology lab. | Diagnostic test | Standard of Care |
Primary outcome
Desirability of Outcome Ranking (DOOR) - composite outcome
Time frame: 30 days
The primary endpoint is the probability that a patient will have a better DOOR when the Accelerate PhenoTest™ BC kit is used on positive blood cultures due to gram-negative rods compared to the standard of care
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Apr 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Accelerate Pheno in people with Gram-negative Bacteremia, run by Accelerate Diagnostics, Inc..
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: withdrawn, as of the sponsor's last update on 14 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Desirability of Outcome Ranking (DOOR) - composite outcome (time frame: 30 days). 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 14 Apr 2020.