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Status unknownNCT03064100Updated Jul 21, 2017

Pilot Evaluation of the FilmArray® Childhood Systemic Infection (CSI) Panel

An observational study in Systemic Infection, sponsored by BioFire Diagnostics, LLC. Status unknown at 3 sites in United States. Open to participants aged Up to 17 Years. Per ClinicalTrials.gov, last updated 2017-07-21.

Sponsored by BioFire Diagnostics, LLC · Observational

The sponsor has not verified this record recently (last verified Feb 2017), so the status shown — last known as Enrolling by invitation — may be out of date.
Study type
Observational
Model
Case-only
Time perspective
Prospective
Enrollment
1,500
Ages
Up to 17 Years
Sex
All
01

Study 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. The study will utilize whole blood and/or plasma obtained from pediatric patients under 18 years of age that present with acute fever.

02

Conditions studied

  • Systemic Infection
03

In context

Lead sponsor

BioFire Diagnostics, LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Up to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Probability sample

Study population

Pediatric patients under the age of 18 suspected of systemic infection

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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)

Exclusion criteria

Exclusion Criteria:

  • 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
05

Study design

Observational model
Case-only
Time perspective
Prospective
Enrollment
1,500 participants (estimated)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Specimens that meet inclusion criteria

    Other: Observational Study

Interventions

  • OtherObservational Study

    Exclusion from the study

06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

3 sites
  • Children's Hospital of Los Angeles
    Los Angeles, California 90027, United States
  • Emory University
    Atlanta, Georgia 30329, United States
  • Children's Mercy Hospital
    Kansas City, Missouri 64108, United States
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Started Mar 2017 (actual). Primary completion is estimated for Feb 2018, 11 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 14, 2017
First posted
Feb 24, 2017
StartActual
Mar 21, 2017
Primary completionEst.
Feb 2018
CompletionEst.
Feb 2018
Last update
Jul 21, 2017
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 21, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03064100
Lead sponsor
BioFire Diagnostics, LLC
Responsible party
Sponsor
First posted
Feb 24, 2017
Start date
Mar 21, 2017
Primary completion
Feb 2018 (estimated)
Completion
Feb 2018 (estimated)
Last update
Jul 21, 2017

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Feb 2017. You cannot join it, but the record below documents what was studied.

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Discussion

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