BacteremiaNCT02719769
Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture
An observational study of Bacteremia and Fungemia, run by Accelerate Diagnostics, Inc. at 14 sites in United States.
Trial summary
The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacteremia, Fungemia
- How many people
- 4,009 participants
- Where
- 14 sitesUnited States
- Study dates
- Jan 2016to 12 Jan 2017
- 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
- No healthy volunteers
- Child, Adult, Older adult
Study population: Clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.
Who may be able to join
- De-identified positive blood culture specimens (6 mL aliquot)
- Seeded blood culture specimens (stock) from archived bacterial and yeast isolates
Who cannot join
- Sample volume available < 6 mL
- Positive Blood Culture sample > 8 hours post-positivity
- Sample from patient previously enrolled
- Sample from blood culture media that contain charcoal e.g., BACTAlert FA, FN bottles
- Samples from Mycobacterial-type blood culture media e.g., BACTEC Myco/F Lytic, BacT/ALERT MP Bottle, VersaTREK Myco
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Johns Hopkins University School of Medicine
Baltimore, Maryland, 21287
The Ohio State University
Columbus, Ohio, 43205
Geisinger Clinic
Danville, Pennsylvania, 17822
Banner Health- Laboratory Sciences of Arizona
Gilbert, Arizona, 85234
University of Iowa Hospitals and Clinics
Iowa City, Iowa, 52242-1396
med fusion LLC
Lewisville, Texas, 75067
Lab Alliance of Central New York LLC
Liverpool, New York, 13088
UCLA Medical Center
Los Angeles, California, 90046
Cedars Sinai Medical Center
Los Angeles, California, 90048
Loyola University Medical Center
Maywood, Illinois, 60153
Medical College of Wisconsin
Milwaukee, Wisconsin, 53276
MRI Global
Palm Bay, Florida, 32909-2211
Mayo Clinic
Rochester, Minnesota, 55905
Accelerate Diagnostics Inc.
Tucson, Arizona, 85714
About this study
Official title: Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing
The "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical setting. The data from this study will be used to support the 510(k) submission for FDA clearance and global registrations of the device intended for in vitro diagnostic use.
Read the detailed description
The clinical study entitled "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to demonstrate the clinical performance of the Accelerate ID/AST System for positive blood culture identification (ID) and antimicrobial susceptibility testing (AST) in a clinical setting compared to reference results. Approximately 3,000 positive blood culture samples (across all Clinical Sites) will be tested on the investigational device and reference methods. Up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. Quality Control testing will be performed each day of testing. The study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. Positive blood culture samples must be tested on the Accelerate ID/AST System within 8 hours of positivity by the blood culture monitoring system. Testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.
- Conditions
- Bacteremia, Fungemia
- Keywords
- Positive Blood Culture
- Medical subject headings
- Bacteremia, Fungemia
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison Study - ID Performance
Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target
Measured: Approximately 9 months (including pre-clinical phase)
Secondary outcomes (1)
Comparison Study - AST Performance
Essential and Categorical Agreement with CLSI Frozen Reference Method (BMD) by Antimicrobial
Measured: Approximately 9 months (including pre-clinical phase)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2016 (estimated)
- Study startJan 2016
- Primary completionMay 2016
- Study completion12 Jan 2017
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
- 4,009 participants (actual)
Sponsor and investigators
- Lead sponsor
- Accelerate Diagnostics, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Constance Bridges, B.S., MBA, Principal investigator, Accelerate Diagnostics, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02719769
- Sponsor's protocol ID
- CP000004
- Other IDs
- CP00002
- Status last verified
- Sep 2017
- First submitted
- 11 Jan 2016
- Last updated
- 27 Sep 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification & Antimicrobial Susceptibility Testing
- ClinicalTrials.gov ID
- NCT02719769
- Acronym / sponsor ID
- CP000004
- Conditions
- Bacteremia, Fungemia
- Keywords
- Positive Blood Culture
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,009 participants (actual)
- Lead sponsor
- Accelerate Diagnostics, Inc.Industry (pharma, biotech, devices)
- Study start
- Jan 2016 (actual)
- Primary completion
- May 2016 (actual)
- Study completion
- 12 Jan 2017 (actual)
- First posted
- 25 Mar 2016 (estimated)
- 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 "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to validate the clinical performance of the Accelerate ID/AST System for positive blood culture identification and susceptibility testing in a clinical setting. The data from this study will be used to support the 510(k) submission for FDA clearance and global registrations of the device intended for in vitro diagnostic use.
Detailed description
The clinical study entitled "Evaluation of Clinical Performance of the Accelerate ID/AST System for Positive Blood Culture Identification \& Antimicrobial Susceptibility Testing" is designed to demonstrate the clinical performance of the Accelerate ID/AST System for positive blood culture identification (ID) and antimicrobial susceptibility testing (AST) in a clinical setting compared to reference results. Approximately 3,000 positive blood culture samples (across all Clinical Sites) will be tested on the investigational device and reference methods. Up to 50% of samples enrolled will be comprised of seeded blood cultures prepared from clinical stock isolates. Quality Control testing will be performed each day of testing. The study population is comprised of left-over clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories. Positive blood culture samples must be tested on the Accelerate ID/AST System within 8 hours of positivity by the blood culture monitoring system. Testing of clinical samples will continue until the required sample size for each target organism and antimicrobial agent, including sufficient on-scale and resistant strains, are tested across all the sites.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Clinical specimens that are indicated as positive by blood culture monitoring systems utilized by clinical microbiology laboratories.
Key inclusion criteria (2 listed)
- De-identified positive blood culture specimens (6 mL aliquot)
- Seeded blood culture specimens (stock) from archived bacterial and yeast isolates
Key exclusion criteria (5 listed)
- Sample volume available < 6 mL
- Positive Blood Culture sample > 8 hours post-positivity
- Sample from patient previously enrolled
- Sample from blood culture media that contain charcoal e.g., BACTAlert FA, FN bottles
- Samples from Mycobacterial-type blood culture media e.g., BACTEC Myco/F Lytic, BacT/ALERT MP Bottle, VersaTREK Myco
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Comparison Study - ID Performance
Time frame: Approximately 9 months (including pre-clinical phase)
Positive and Negative Percent Agreement with Comparator Method (Vitek2) by Bacterial/Fungal Target
1 secondary outcome
Comparison Study - AST Performance
Time frame: Approximately 9 months (including pre-clinical phase)
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 27 Sep 2017.
- 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.
Constance Bridges, B.S., MBA principal investigator
Accelerate Diagnostics, Inc.
14 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 and Fungemia, run by Accelerate Diagnostics, Inc. at 14 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 2 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 27 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 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?
Comparison Study - ID Performance (time frame: Approximately 9 months (including pre-clinical phase)). 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 27 Sep 2017.