Back to resultsFilm Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
Primary Purpose
Infectious Diarrhea
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Biofire Film Array Gastrointestinal Panel
Sponsored by
About this trial
This is an interventional treatment trial for Infectious Diarrhea
Eligibility Criteria
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
Sites / Locations
- The George Washington University, Department of Emergency Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental
Control
Arm Description
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
ED Length of Stay
Time from patient arrival to time when patient is officially discharged or admitted
Hospital Admission Rate
Rate of Abdominal/Pelvic CT Scans
Full Information
NCT ID
NCT03809117
First Posted
November 13, 2018
Last Updated
November 28, 2022
Sponsor
Andrew Meltzer
Collaborators
BioFire Diagnostics, LLC
1. Study Identification
Unique Protocol Identification Number
NCT03809117
Brief Title
Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
Official Title
A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Terminated
Why Stopped
Study was halted due to obstacles faced in executing clinical procedures as a result of the COVID-19 pandemic.
Study Start Date
November 19, 2018 (Actual)
Primary Completion Date
March 15, 2020 (Actual)
Study Completion Date
September 7, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Andrew Meltzer
Collaborators
BioFire Diagnostics, LLC
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infectious Diarrhea
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
74 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental
Arm Type
Experimental
Arm Description
Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Arm Title
Control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Biofire Film Array Gastrointestinal Panel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Participants With Optimal Antibiotic Chosen
Description
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.
Time Frame
30 Days post ED Discharge
Secondary Outcome Measure Information:
Title
ED Length of Stay
Description
Time from patient arrival to time when patient is officially discharged or admitted
Time Frame
30 Days post ED Discharge
Title
Hospital Admission Rate
Time Frame
30 Days post ED Discharge
Title
Rate of Abdominal/Pelvic CT Scans
Time Frame
30 Days post ED Discharge
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Andrew Meltzer, MD, MS
Organizational Affiliation
The George Washington University
Official's Role
Principal Investigator
Facility Information:
Facility Name
The George Washington University, Department of Emergency Medicine
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
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