Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea

Study Overview
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Brief Summary
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This research study will test a laboratory test called Film-Array Gastrointestinal (GI) Panel. This GI Panel is a test that can identify the bacteria or viruses that may cause diarrhea. This test will enable the ED doctor to better understand the cause of diarrhea to try to determine the best treatment. 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.

Official Title
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A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department

Conditions
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Infectious Diarrhea

Intervention / Treatment
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* Diagnostic Test: Biofire Film Array Gastrointestinal Panel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presumed infectious diarrhea (3 or more loose stools in past 24 hours) Must have one of the 3 following features or symptoms lasting more than 7 days. Symptoms greater than 24 hours; 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.)) Inflammation (defined as fever (greater than 100.1), blood in stool per patient, DRE, or tenesmus.) Exclusion Criteria: Chronic Symptoms (>14 days) 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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician. | Diagnostic Test: Biofire Film Array Gastrointestinal Panel<br>* 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.<br>|
| Active Comparator: Control<br>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. | Diagnostic Test: Biofire Film Array Gastrointestinal Panel<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Optimal Antibiotic Chosen | Optimal use of antibiotics is defined as the most appropriate antibiotic to treat a specified pathogen. Designated physicians on study staff will retrospectively examine charts of enrolled subjects will evaluate whether the antibiotic chosen by treating clinician was appropriate given GI PCR results. | 30 Days post ED Discharge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ED Length of Stay | Time from patient arrival to time when patient is officially discharged or admitted | 30 Days post ED Discharge | 
| Hospital Admission Rate |  | 30 Days post ED Discharge | 
| Rate of Abdominal/Pelvic CT Scans |  | 30 Days post ED Discharge |