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

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

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.

Study Overview

• Status: Terminated
• Conditions: Infectious Diarrhea
• Intervention / Treatment: Diagnostic test: Biofire Film Array Gastrointestinal Panel

• Study Type: Interventional
• Enrollment (Actual): 74
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Andrew C Meltzer, MD, MS; Phone Number: 202-741-2952; Email: ameltzer@mfa.gwu.edu
• Study Contact Backup: Name: Maxine LeSaux; Phone Number: 202-741-2917; Email: mlesaux@mfa.gwu.edu

Study Locations

• United States
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The George Washington University, Department of Emergency Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

  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:

• 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

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental; 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; 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.
Active Comparator: 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.	Diagnostic test: 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Andrew Meltzer
• Collaborators: BioFire Diagnostics, LLC
• Investigators: Principal Investigator: Andrew Meltzer, MD, MS, The George Washington University

Study record dates

Study Major Dates

• Study Start (Actual): November 19, 2018
• Primary Completion (Actual): March 15, 2020
• Study Completion (Actual): September 7, 2020

Study Registration Dates

• First Submitted: November 13, 2018
• First Submitted That Met QC Criteria: January 15, 2019
• First Posted (Actual): January 18, 2019

Study Record Updates

• Last Update Posted (Actual): December 20, 2022
• Last Update Submitted That Met QC Criteria: November 28, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Gastroenteritis; Intestinal Diseases; Infections; Communicable Diseases; Diarrhea; Dysentery
• Other Study ID Numbers: IRB #051839

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No