INFECTIONSNCT02796716
Study of Accuracy of New Diagnostic Technology to Guide Rapid Antibiotic Treatment for Serious Infections
An observational study of INFECTIONS and Skin and Subcutaneous Tissue Bacterial Infections, run by Denver Health and Hospital Authority at 1 site in United States.
Trial summary
This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- INFECTIONS, Skin and Subcutaneous Tissue Bacterial Infections, Healthcare-associated Infection
- What is being tested?
- Testing on new technology called Accelerate ID/AST system
- Type of treatment
- Medical device
- How many people
- 2,102 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Dec 2016
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inpatient or outpatient with a sample being sent for microbiology culture (respiratory, blood or tissue/skin).
Who may be able to join
- Age ≥ 18 years old
- Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care.
Who cannot join
- Insufficient sample volume available after sufficient aliquot removed for usual care.
Trial locations and contacts
1 site in 1 country.
United States1 site
Denver Health Medical Center
Denver, Colorado, 80204
About this study
Official title: Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans - Task 3
This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.
To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.
- Conditions
- INFECTIONS, Skin and Subcutaneous Tissue Bacterial Infections, Healthcare-associated Infection, Infection Due to Resistant Bacteria
- Being tested
- Testing on new technology called Accelerate ID/AST system
- Keywords
- Wounded warriors, Battlefield infection, ESBL, MRSA, KPC
- Medical subject headings
- Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Testing on new technology called Accelerate ID/AST systemDevice
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in empiric antimicrobial use
Antibiotic use from the time of specimen collection until antibiotic susceptibility testing results are available to treating clinicians. Antibiotic use will be measured in days of therapy (DOT). DOT in usual care and simulated ID/AST Accelerate system will be compared
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jun 2016 (estimated)
- Study startJul 2015
- Primary completionDec 2016
- Study completionDec 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for INFECTIONSStudies 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
- 2,102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Denver Health and Hospital Authority
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Defense, Accelerate Diagnostics, Inc.
- Responsible party
- Sponsor
- Investigators
- Connie S Price, MD, Principal investigator, Denver HealthIvor S Douglas, MD, Principal investigator, Denver Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02796716
- Sponsor's protocol ID
- 14-1193
- Status last verified
- Feb 2017
- First submitted
- 11 May 2016
- Last updated
- 2 Feb 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 2 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rapid Microbiological Diagnostics for MDRO Quantitative Identification and Resistance Phenotyping to Guide Antibiotic Selection in Wounded Warriors and Veterans - Task 3
- ClinicalTrials.gov ID
- NCT02796716
- Acronym / sponsor ID
- 14-1193
- Conditions
- INFECTIONS, Skin and Subcutaneous Tissue Bacterial Infections, Healthcare-associated Infection, Infection Due to Resistant Bacteria
- Keywords
- Wounded warriors, Battlefield infection, ESBL, MRSA, KPC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 2,102 participants (actual)
- Lead sponsor
- Denver Health and Hospital AuthorityUniversity, hospital or other
- Collaborators
- United States Department of Defense, Accelerate Diagnostics, Inc.
- Study start
- Jul 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 13 Jun 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.
This research will test a new ultra-rapid technology (called ID/AST Accelerate system) that uses a digital microscope to identify bacteria based on their growth patterns. This method does not have to wait for bacteria to grow in a lab. The new method can identify the type of bacteria within 2 hours of receiving a specimen. The new method also shows the effect of selected antibiotics on the bacteria including multidrug resistant bacteria so that doctors know within 6 hours from specimen collection which antibiotic kills the bacteria.
To check the accuracy, speed and impact of the new method on antibiotic prescribing, investigators are proposing a study with two parts; The first part will test the accuracy and speed of the results obtained by the new method. The second part will test if having the results from the new method early would change the antibiotics prescribed to a patient in a simulation experiment. An independent infectious disease physician will be shown the results from the new method and asked if the results were accurate, would it change the antibiotic treatment for the patient.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inpatient or outpatient with a sample being sent for microbiology culture (respiratory, blood or tissue/skin).
Key inclusion criteria (2 listed)
- Age ≥ 18 years old
- Remnant sample from available from microbiology culture (respiratory, blood or tissue/skin) ordered as part of usual clinical care.
Key exclusion criteria (1 listed)
- Insufficient sample volume available after sufficient aliquot removed for usual care.
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 |
|---|---|---|
| Testing on new technology called Accelerate ID/AST system | Device | – |
Primary outcome
Difference in empiric antimicrobial use
Time frame: 1.5 years
Antibiotic use from the time of specimen collection until antibiotic susceptibility testing results are available to treating clinicians. Antibiotic use will be measured in days of therapy (DOT). DOT in usual care and simulated ID/AST Accelerate system will be compared
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 2 Feb 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.
Connie S Price, MD principal investigator
Denver Health
Ivor S Douglas, MD principal investigator
Denver Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of INFECTIONS and Skin and Subcutaneous Tissue Bacterial Infections, run by Denver Health and Hospital Authority 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 1 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 2 Feb 2017. 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?
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?
Difference in empiric antimicrobial use (time frame: 1.5 years). 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 2 Feb 2017.