An interventional study of FilmArray™ Gastrointestinal (GI) Panel in Infectious Gastroenteritis, sponsored by BioFire Diagnostics, LLC. Completed at 5 sites in United States. Open to participants aged Up to 18 Years. Per ClinicalTrials.gov, last updated 2017-12-26.
Sponsored by BioFire Diagnostics, LLC · Not applicable, Interventional, and Diagnostic
BioFire Diagnostics, LLC (BioFire) has developed the FilmArray Gastrointestinal (GI) Panel, a rapid, easy to use PCR-based in vitro diagnostic test for the identification of 22 common microorganisms responsible for infectious gastroenteritis (http://filmarray.com/the-panels/) from a stool specimen collected in Cary Blair enteric transport media. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014.
The FilmArray GI Panel offers improvements over conventional laboratory testing which include: reduced turnaround time from specimen to result, reduced laboratory labor costs, increased sensitivity and specificity relative to current clinical reference methods, and larger breadth of organism identification than is available using standard methods. Because of these attributes, the results from this test have the potential to enable clinicians to more accurately diagnose and treat GI illness in a reduced time frame.
Collaborators at the University of Utah, Brown University/Lifespan, and BioFire Diagnostics have designed a study to evaluate health outcomes of pediatric subjects presenting to emergency departments with GI illness before and after establishing the FilmArray GI Panel as the standard of care method for stool pathogen analysis. It is hypothesized that the rapid (\~ 1 hour turnaround time), sensitive, specific, and comprehensive results provided by the FilmArray GI Panel will allow clinicians to more rapidly diagnose GI illness, initiate appropriate therapy and provide guidance when compared to the pre-implementation period.
BioFire Diagnostics, LLC is the lead sponsor of 10 studies on the registry; 1 is open to participants now.
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Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
FilmArray™ GI Panel testing will be standard of care and provided at no cost. Additional testing may be ordered at the discretion of the clinician.
Device: FilmArray™ Gastrointestinal (GI) Panel
Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
BioFire Diagnostics, LLC (BioFire) has developed a polymerase chain reaction (PCR), high-resolution melting analysis instrument called the FilmArray™ and an associated reagent pouch that together are capable of simultaneously detecting multiple microorganisms in a single sample. The FilmArray™ Gastrointestinal (GI) Panel pouch contains freeze-dried reagents to perform nucleic acid purification and nested, multiplex PCR for the identification of common bacterial, viral, and parasite microorganisms responsible for infectious gastroenteritis. The test was made available for sale in the US and EU following FDA clearance and CE marking in May, 2014
Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel
Describing of etiology of diarrheal illness in the study as identified by each method
Time frame: Seven to ten days after enrollment
| Milestone | Intervention | Pre-intervention |
|---|---|---|
| Started | 687 | 858 |
| Completed | 586 | 571 |
| Not completed | 101 | 287 |
Describing of etiology of diarrheal illness in the study as identified by each method
| Participants | Intervention | Pre-intervention |
|---|---|---|
| Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel | 434 | 19 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Intervention | 0/586 (0%) | 0/586 (0%) | 0/586 (0%) |
| Pre-intervention | 0/571 (0%) | 0/571 (0%) | 0/571 (0%) |
| Age, Categorical(Participants) | Intervention | Pre-intervention | Total |
|---|---|---|---|
| <=18 years | 586 | 571 | 1157 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 0 | 0 |
| Age, Continuous(years) | Intervention | Pre-intervention | Total |
|---|---|---|---|
| Median | 2.7 (1.2 to 7.8) | 3 (1.2 to 7.0) | 2.8 (1.2 to 7.8) |
| Sex: Female, Male(Participants) | Intervention | Pre-intervention | Total |
|---|---|---|---|
| Female | 272 | 300 | 572 |
| Male | 314 | 271 | 585 |
| Race and Ethnicity Not Collected(Participants) | Intervention | Pre-intervention | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(participants) | Intervention | Pre-intervention | Total |
|---|---|---|---|
| United States | 586 | 571 | 1157 |
This study is completed, as verified in Nov 2017. You cannot join it, but the record below documents what was studied.
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