Acute FeverNCT02477683
Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel
An observational study of Acute Fever, run by BioFire Diagnostics, LLC at 6 sites in United States.
Trial summary
The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray FI reagent pouch. Read more about this study
- Who is it for?
- Ages Up to 3 years
- Conditions the study is for
- Acute Fever
- How many people
- 1,514 participants
- Where
- 6 sitesUnited States
- Study dates
- Oct 2015to Oct 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 Up to 3 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients under the age of 3 with acute fever.
Who may be able to join
- under age of 3
- has fever with no obvious focal infection
- written informed parental permission
Who cannot join
- parent/legal guardian unable to provide permission
- participation determined by a physician to be detrimental to patient health
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Emory University
Atlanta, Georgia, 30329
Nationwide Children's Hospital
Columbus, Ohio, 43205
Indiana University School of Medecine
Indianapolis, Indiana, 46202
Children's Mercy Hospitals & Clinics
Kansas City, Missouri, 64108
Primary Children's Hospital
Salt Lake City, Utah, 84108
Washington University in St. Louis
St Louis, Missouri, 63110
About this study
The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.
- Conditions
- Acute Fever
What is being measured
The primary outcome is the main question the study is designed to answer.
Utility of multiplexed testing for pathogens in pediatric patients with acute fever
Measured: 15 months
Secondary outcomes (1)
Epidemiology of pathogens in pediatric patients with acute fever
Measured: 15 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2015 (estimated)
- Study startOct 2015
- Primary completionOct 2016
- Study completionOct 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute FeverStudies 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
- 1,514 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioFire Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02477683
- Sponsor's protocol ID
- BFDxFIPilot
- Status last verified
- Dec 2016
- First submitted
- 18 Jun 2015
- Last updated
- 21 Dec 2016
- Results posted
- 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
- Pilot Evaluation of the FilmArray® Febrile Infant (FI) Panel
- ClinicalTrials.gov ID
- NCT02477683
- Acronym / sponsor ID
- BFDxFIPilot
- Conditions
- Acute Fever
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,514 participants (actual)
- Lead sponsor
- BioFire Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2015
- Primary completion
- Oct 2016 (actual)
- Study completion
- Oct 2016 (actual)
- First posted
- 23 Jun 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.
The purpose of this study is to collect data to support decisions made by BioFire regarding assay development, panel composition, and intended use for the final FilmArray FI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 3 years of age that present with acute fever.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- Up to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients under the age of 3 with acute fever.
Key inclusion criteria (3 listed)
- under age of 3
- has fever with no obvious focal infection
- written informed parental permission
Key exclusion criteria (2 listed)
- parent/legal guardian unable to provide permission
- participation determined by a physician to be detrimental to patient health
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
Utility of multiplexed testing for pathogens in pediatric patients with acute fever
Time frame: 15 months
1 secondary outcome
Epidemiology of pathogens in pediatric patients with acute fever
Time frame: 15 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 Acute Fever, 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 3 inclusion and 2 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?
Utility of multiplexed testing for pathogens in pediatric patients with acute fever (time frame: 15 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.