Systemic InfectionNCT03064100
Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
An observational study of Systemic Infection, run by BioFire Diagnostics, LLC at 3 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 CSI reagent pouch. Read more about this study
- Who is it for?
- Ages Up to 17 years
- Conditions the study is for
- Systemic Infection
- What is being tested?
- Observational Study
- How many people
- 1,500 participants
- Where
- 3 sitesUnited States
- Study dates
- 21 Mar 2017to Feb 2018
- 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 17 years
- All sexes
- No healthy volunteers
- Child
Study population: Pediatric patients under the age of 18 suspected of systemic infection
Who may be able to join
- Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture
- Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity)
- Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED)
- Specimen is at least 500 µL (1.5 mL collection desired)
Who cannot join
- Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity)
- Physician determines that participation in the study is an unacceptable health risk
- Minimum volume requirement is not met
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Emory University
Atlanta, Georgia, 30329
Children's Mercy Hospital
Kansas City, Missouri, 64108
Children's Hospital of Los Angeles
Los Angeles, California, 90027
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 CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.
- Conditions
- Systemic Infection
- Being tested
- Observational Study
- Medical subject headings
- Toxemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Observational StudyOther
Exclusion from the study
| Study group | Role | What they receive |
|---|---|---|
| Specimens that meet inclusion criteria | Not described Receives: Other: Observational Study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays)
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2017
- Study start21 Mar 2017
- Primary completionFeb 2018 (estimated)
- Study completionFeb 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic InfectionStudies 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
- 1,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- BioFire Diagnostics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03064100
- Sponsor's protocol ID
- BFDxCSIPilot
- Status last verified
- Feb 2017
- First submitted
- 14 Feb 2017
- Last updated
- 21 Jul 2017
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jul 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel
- ClinicalTrials.gov ID
- NCT03064100
- Acronym / sponsor ID
- BFDxCSIPilot
- Conditions
- Systemic Infection
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,500 participants (estimated)
- Lead sponsor
- BioFire Diagnostics, LLCIndustry (pharma, biotech, devices)
- Study start
- 21 Mar 2017 (actual)
- Primary completion
- Feb 2018 (estimated)
- Study completion
- Feb 2018 (estimated)
- First posted
- 24 Feb 2017 (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.
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 CSI reagent pouch. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Specimens that meet inclusion criteria | – | Other: Observational Study |
Who may qualify
- Ages
- Up to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Pediatric patients under the age of 18 suspected of systemic infection
Key inclusion criteria (4 listed)
- Subject has presented to the ED and is suspected of a systemic infection as indicated by a clinician order for blood culture
- Parent/guardian gives written permission (and assent is obtained from children of sufficient maturity)
- Blood specimen can be collected at the same time as the blood culture during the ED visit (or within 12 hours of being admitted from the ED)
- Specimen is at least 500 µL (1.5 mL collection desired)
Key exclusion criteria (3 listed)
- Parent/guardian is unavailable or unable to give permission, or assent is not obtained (from children of sufficient maturity)
- Physician determines that participation in the study is an unacceptable health risk
- Minimum volume requirement is not met
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 StudyExclusion from the study | Other | Specimens that meet inclusion criteria |
Primary outcome
Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays)
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jul 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.
The record lists no contact. Use the official record to reach the sponsor.
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 Systemic Infection, run by BioFire Diagnostics, LLC 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 4 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 21 Jul 2017. 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?
Results are not available in the source record.
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?
Sensitivity (or positive percent agreement) and specificity (or negative percent agreement) of the assays comprising FilmArray CSI Panel with respect to reference methods (bacterial culture and independent molecular assays) (time frame: 12 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 Jul 2017.