Trial Outcomes & Findings for Implementation of a Molecular Diagnostic for Pediatric Acute Gastroenteritis: The FilmArray GI Panel IMPACT Study (NCT NCT02248285)

NCT ID: NCT02248285

Last Updated: 2017-12-26

Results Overview

Describing of etiology of diarrheal illness in the study as identified by each method

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 1545 participants
• Primary outcome timeframe: Seven to ten days after enrollment
• Results posted on: 2017-12-26

Participant Flow

Participant milestones

Measure	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	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.
Overall Study STARTED	687	858
Overall Study COMPLETED	586	571
Overall Study NOT COMPLETED	101	287

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	Intervention n=586 Participants 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	Pre-intervention n=571 Participants Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.	Total n=1157 Participants Total of all reporting groups
Age, Categorical <=18 years	586 Participants n=586 Participants	571 Participants n=571 Participants	1157 Participants n=1157 Participants
Age, Categorical Between 18 and 65 years	0 Participants n=586 Participants	0 Participants n=571 Participants	0 Participants n=1157 Participants
Age, Categorical >=65 years	0 Participants n=586 Participants	0 Participants n=571 Participants	0 Participants n=1157 Participants
Age, Continuous	2.7 years n=586 Participants	3 years n=571 Participants	2.8 years n=1157 Participants
Sex: Female, Male Female	272 Participants n=586 Participants	300 Participants n=571 Participants	572 Participants n=1157 Participants
Sex: Female, Male Male	314 Participants n=586 Participants	271 Participants n=571 Participants	585 Participants n=1157 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	586 participants n=586 Participants	571 participants n=571 Participants	1157 participants n=1157 Participants

PRIMARY outcome

Timeframe: Seven to ten days after enrollment

Describing of etiology of diarrheal illness in the study as identified by each method

Outcome measures

Measure	Intervention n=586 Participants 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	Pre-intervention n=64 Participants Testing will be at the discretion of the clinician using standard laboratory tests, and specimens will be collected as appropriate for these methods.
Analysis of Diarrheal Illness Etiologies Identified in Stool Culture Compared to the FilmArray™ Gastrointestinal (GI) Panel	434 Participants	19 Participants

Adverse Events

Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Pre-intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Director of Clinical Affairs

BioFire Diagnostics

Phone: 8017366354

Email: kevin.bourzac@biofiredx.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place