Evaluation of Test PanelNCT02547636
Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel
An observational study of Evaluation of Test Panel, run by BioFire Diagnostics, LLC at 6 sites in United States.
Trial summary
This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Evaluation of Test Panel
- What is being tested?
- Observational study
- How many people
- 1,822 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Subjects with fever will be prospectively enrolled, and whole blood will be collected. Additional residual specimens left-over from standard of care laboratory testing will also be enrolled.
Who may be able to join
- Whole blood (prospectively collected via informed consent):
- Adult subject has a recorded or self-reported fever within the previous 24 hours
- Subject provides informed consent prior to enrollment and specimen collection
- Subject has not previously provided a whole blood specimen for this study
- Whole blood (residual)
- Whole blood (in EDTA) submitted to laboratory for standard of care testing
Show all 16Show fewer
- Specimen is not from an individual with a specimen previously enrolled in the study
- Positive Blood Culture:
- Culture was detected as positive by an automated blood culture system
- Culture is not from a patient previously enrolled in the study
- Negative Blood Culture:
- Culture not detected as positive by an automated blood culture system
- Culture is not from a patient previously enrolled in the study
- Sputum:
- Specimen was accepted for testing by the respective site's microbiology laboratory
- Specimen is not from an individual that has a sputum already enrolled in the study
Who cannot join
None listed.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Ohio State University Medical Center
Columbus, Ohio
Tripler Army Medical Center
Honolulu, Hawaii
University of Nebraska Medical Center
Omaha, Nebraska
Navy Medical Center San Diego/Naval Health Research Center
San Diego, California
Washington University/Barnes Jewish Hospital
St Louis, Missouri
Madigan Army Medical Center
Tacoma, Washington
About this study
This study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.
- Conditions
- Evaluation of Test Panel
- Being tested
- Observational study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational studyOther
No intervention will be used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Subjects/specimens that meet the inclusion criteria | Subjects/specimens that meet the inclusion criteria Receives: Other: Observational study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical specificity of the FilmArray NGDS Warrior Panel
Measured: 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2015 (estimated)
- Study startDec 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 Evaluation of Test PanelStudies 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,822 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioFire Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- BioFire Defense LLC
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02547636
- Sponsor's protocol ID
- DX-SDY-020450
- Status last verified
- Dec 2016
- First submitted
- 10 Sep 2015
- Last updated
- 21 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Evaluation of the FilmArray® NGDS Warrior Panel
- ClinicalTrials.gov ID
- NCT02547636
- Acronym / sponsor ID
- DX-SDY-020450
- Conditions
- Evaluation of Test Panel
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,822 participants (actual)
- Lead sponsor
- BioFire Diagnostics, LLCIndustry (pharma, biotech, devices)
- Collaborators
- BioFire Defense LLC
- Study start
- Dec 2015
- Primary completion
- Dec 2016 (actual)
- Study completion
- Dec 2016 (actual)
- First posted
- 11 Sep 2015 (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 study will evaluate the clinical specificity of the FilmArray NGDS Warrior Panel.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects/specimens that meet the inclusion criteria | – | Other: Observational studySubjects/specimens that meet the inclusion criteria |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Subjects with fever will be prospectively enrolled, and whole blood will be collected. Additional residual specimens left-over from standard of care laboratory testing will also be enrolled.
Key inclusion criteria (16 listed)
- Whole blood (prospectively collected via informed consent):
- Adult subject has a recorded or self-reported fever within the previous 24 hours
- Subject provides informed consent prior to enrollment and specimen collection
- Subject has not previously provided a whole blood specimen for this study
- Whole blood (residual)
Key exclusion criteria (0 listed)
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 |
|---|---|---|
| Observational studyNo intervention will be used in this study. | Other | Subjects/specimens that meet the inclusion criteria |
Primary outcome
Clinical specificity of the FilmArray NGDS Warrior Panel
Time frame: 8 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 21 Dec 2016.
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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.
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Evaluation of Test Panel, run by BioFire Diagnostics, LLC at 6 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 16 inclusion and 0 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 21 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 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?
Clinical specificity of the FilmArray NGDS Warrior Panel (time frame: 8 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 21 Dec 2016.