BacteremiaNCT04295915
Clinical Performance and Reproducibility of the Accelerate PhenoTest™ Blood Culture (BC) Kit With New Antibiotic Wave I Updates
An observational study of Bacteremia, run by Accelerate Diagnostics, Inc. at 3 sites in United States.
Trial summary
This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Bacteremia
- What is being tested?
- Specimens that meet inclusion criteria
- Type of treatment
- Medical device
- How many people
- 731 participants
- Where
- 3 sitesUnited States
- Study dates
- 11 Mar 2020to 19 Apr 2022
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Clinical or contrived (seeded bacterial isolate) specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.
Who may be able to join
- Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system
- Positive blood culture sample containing gram-negative rods according to Gram stain results
- For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded
- A minimum sample volume of 2.0 mL
- Seeded blood culture specimens derived from archived bacterial
Who cannot join
- Blood culture positivity is > 8 hours prior to initiation of testing with the Accelerate Pheno™ system
- Insufficient (less than 2.0 mL) remnant sample volume
- From a patient that has already been enrolled in the study
- Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media
- Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Penn State-Hershey Medical Center
Hershey, Pennsylvania, 17033
Quest/med fusion
Lewisville, Texas, 75067
Accelerate Diagnostics
Tucson, Arizona, 85714
About this study
Official title: Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System With New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens
This is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.
Read the detailed description
This clinical study entitled "Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens" is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017.
Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens.
The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB).
It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.
- Conditions
- Bacteremia
- Being tested
- Specimens that meet inclusion criteria
- Keywords
- Positive blood culture
- Medical subject headings
- Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Specimens that meet inclusion criteriaDevice
Specimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study.
| Study group | Role | What they receive |
|---|---|---|
| Specimens that meet inclusion criteria | Not described Receives: Device: Specimens that meet inclusion criteria |
What is being measured
The primary outcome is the main question the study is designed to answer.
Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method
Measured: Approximately 4 months
Secondary outcomes (1)
Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results
Measured: Approximately 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start11 Mar 2020
- Primary completion2 Dec 2021
- Study completion19 Apr 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 731 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accelerate Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Shelley Campeau, Study director, Accelerate Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04295915
- Sponsor's protocol ID
- CP000026
- Status last verified
- Apr 2022
- First submitted
- 3 Mar 2020
- Last updated
- 22 Apr 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
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
- Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System With New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens
- ClinicalTrials.gov ID
- NCT04295915
- Acronym / sponsor ID
- CP000026
- Conditions
- Bacteremia
- Keywords
- Positive blood culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 731 participants (actual)
- Lead sponsor
- Accelerate Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- 11 Mar 2020 (actual)
- Primary completion
- 2 Dec 2021 (actual)
- Study completion
- 19 Apr 2022 (actual)
- First posted
- 5 Mar 2020 (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 is a performance and reproducibility study to validate new or updated antimicrobials on the Accelerate PhenoTest™ BC kit. The data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.
Detailed description
This clinical study entitled "Clinical Performance and Reproducibility of the Accelerate PhenoTest™ BC Kit Using the Accelerate Pheno™ System with New Antibiotic Wave I Updates for Antimicrobial Susceptibility Testing of Positive Blood Culture Specimens" is designed to demonstrate the clinical performance and reproducibility of the new or updated antimicrobials on the Accelerate PhenoTest™ BC kit, which was previously FDA-cleared in February 2017.
Clinical performance and reproducibility evaluations will be conducted at a minimum of three sites to determine the clinical performance of the new or updated antimicrobials from a combination of fresh (de-identified, remnant specimens) and contrived positive blood culture samples, to include at least 375 total specimens.
The study sites selected will have expertise in blood culture diagnostics and will be able to conduct the study in accordance with this protocol and Good Clinical Practices (GCP). Additionally, prior to study initiation, each site will have approval from the local Institutional Review Board (IRB).
It is anticipated that the data from this study will be used to support the submission to the FDA for clearance in the US and for global registrations of the device intended for in vitro diagnostic use.
Study design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimens that meet inclusion criteria | – | Device: Specimens that meet inclusion criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical or contrived (seeded bacterial isolate) specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.
Key inclusion criteria (5 listed)
- Blood culture positivity is ≤ 8 hours prior to initiation of testing with the Accelerate Pheno™ system
- Positive blood culture sample containing gram-negative rods according to Gram stain results
- For fresh specimens, de-identified, remnant positive blood culture specimens from patients for which Standard of Care (SOC) testing has been initiated and the remaining samples would otherwise be discarded
- A minimum sample volume of 2.0 mL
- Seeded blood culture specimens derived from archived bacterial
Key exclusion criteria (5 listed)
- Blood culture positivity is > 8 hours prior to initiation of testing with the Accelerate Pheno™ system
- Insufficient (less than 2.0 mL) remnant sample volume
- From a patient that has already been enrolled in the study
- Fresh samples from Mycobacterial-type blood culture media (BACTEC™ Myco/F Lytic, BacT/ALERT® MP Bottle, VersaTREK® Myco) or charcoal-containing media
- Seeded specimens that appear mixed (by Gram stain or purity plating) after bottle culture positivity
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 |
|---|---|---|
| Specimens that meet inclusion criteriaSpecimens that have been de-identified and considered remnant by the laboratory (fresh specimens) or were contrived by the laboratory (using bacterial isolates with no identifying information) can be enrolled into the study. | Device | Specimens that meet inclusion criteria |
Primary outcome
Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method
Time frame: Approximately 4 months
1 secondary outcome
Essential agreement of MICs compared to the modal MIC values obtained for intra- and inter-laboratory results
Time frame: Approximately 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2022.
- 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.
Shelley Campeau study director
Accelerate Diagnostics, Inc.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bacteremia, run by Accelerate Diagnostics, Inc. at 3 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 5 inclusion and 5 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 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 3 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Essential and categorical agreement with Clinical and Laboratory Standards Institute (CLSI) broth microdilution reference method (time frame: Approximately 4 months). 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.