Infectious Gastroenteritis
Conditions
Keywords
multiplex, polymerase chain reaction, PCR, BioFire Diagnostics, Infectious gastroenteritis, Diarrheal disease, Emergency department, rapid diagnostics, FilmArray, FilmArray GI Panel
Brief summary
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.
Interventions
DEVICEFilmArray™ Gastrointestinal (GI) Panel
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
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
BioFire Diagnostics, LLC
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
No minimum to 18 Years
Healthy volunteers
No
Inclusion criteria
* Children (\<18 years) presenting to the ED or onsite urgent care center with symptoms of gastroenteritis (e.g. diarrhea, vomiting, nausea, etc.) * Duration of symptoms at least 24 hours but \< 14 days * Able to provide stool specimen at time of enrollment or within the next two calendar days * Parent or guardian able to provide permission and subject able to provide assent, if appropriate
Exclusion criteria
* Undefined onset of illness or symptoms for ≥14 days * Unable to complete questionnaire or give informed consent because of language barrier * Those unable to provide stool specimen at time of enrollment or within two calendar days * Previous enrollment in this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel | Seven to ten days after enrollment | Describing of etiology of diarrheal illness in the study as identified by each method |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Intervention 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.
FilmArray™ Gastrointestinal (GI) Panel: 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 | 586 |
| Pre-intervention Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods. | 571 |
| Total | 1,157 |
Baseline characteristics
| Characteristic | Pre-intervention | Total | Intervention |
|---|---|---|---|
| Age, Categorical <=18 years | 571 Participants | 1157 Participants | 586 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Continuous | 3 years | 2.8 years | 2.7 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 571 participants | 1157 participants | 586 participants |
| Sex: Female, Male Female | 300 Participants | 572 Participants | 272 Participants |
| Sex: Female, Male Male | 271 Participants | 585 Participants | 314 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 586 | 0 / 571 |
| other Total, other adverse events | 0 / 586 | 0 / 571 |
| serious Total, serious adverse events | 0 / 586 | 0 / 571 |
Outcome results
Primary
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
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Intervention | Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel | 434 Participants |
| Pre-intervention | Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel | 19 Participants |