Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
NCT ID: NCT03809117
Last Updated: 2022-12-20
Study Results
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View full resultsBasic Information
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TERMINATED
NA
74 participants
INTERVENTIONAL
2018-11-19
2020-09-07
Brief Summary
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The primary objective of this study is to determine if testing ED patients who complain of diarrhea will lead to more optimal use of antibiotics. Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Experimental
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Biofire Film Array Gastrointestinal Panel
The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
Control
Gastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
Biofire Film Array Gastrointestinal Panel
The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
Interventions
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Biofire Film Array Gastrointestinal Panel
The 22-target FilmArray® GI Panel allows a syndromic approach to the diagnosis of infectious diarrhea as it includes bacteria, viruses and parasites in one test. Results are typically available within two hours of collection.
Eligibility Criteria
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Inclusion Criteria
* Must have one of the 3 following features or symptoms lasting more than 7 days.
1. Symptoms greater than 24 hours;
2. Dehydration (defined as the need for intravenous fluid or per clinician's judgement ((based on the general appearance and alertness of the patient, the pulse, the blood pressure, the presence or absence of postural hypotension, the mucous membranes and tears, sunken eyes, skin turgor, capillary refill, and jugular venous pressure.))
3. Inflammation (defined as fever (greater than 100.1), blood in stool per patient, DRE, or tenesmus.)
Exclusion Criteria
* Inability to Follow- Up (i.e. no telephone)
* Prisoner
* Likely non-infectious cause of diarrhea (Crohn's disease, radiation colitis, irritable bowel syndrome, or celiac disease)
* Confirmed C. Diff Diarrhea
* Unable to provide written consent
* Non- English speaker
18 Years
ALL
No
Sponsors
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BioFire Diagnostics, LLC
INDUSTRY
Andrew Meltzer
OTHER
Responsible Party
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Andrew Meltzer
Associate Professor of Emergency Medicine
Principal Investigators
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Andrew Meltzer, MD, MS
Role: PRINCIPAL_INVESTIGATOR
The George Washington University
Locations
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The George Washington University, Department of Emergency Medicine
Washington D.C., District of Columbia, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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IRB #051839
Identifier Type: -
Identifier Source: org_study_id