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

NCT03809117 | Terminated Results FDA Device

• 1 other identifier: IRB #051839
• Study Type: interventional
• Target: 74
• Locations: 1 country
• Sites: 1

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.

Conditions

Infectious Diarrhea

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• ED Length of Stay

  30 Days post ED Discharge

• Hospital Admission Rate

  30 Days post ED Discharge

• Rate of Abdominal/Pelvic CT Scans

  30 Days post ED Discharge

Study Arms (2)

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

Control

ACTIVE COMPARATOR

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

Interventions

Biofire Film Array Gastrointestinal Panel DIAGNOSTIC_TEST

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; Experimental

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.)

You may not qualify if:

• 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

Sponsors & Collaborators

• Andrew Meltzer: lead
• BioFire Diagnostics, LLC: collaborator

Study Sites (1)

The George Washington University, Department of Emergency Medicine

Washington D.C., District of Columbia, 20037, United States

Location

MeSH Terms

Conditions

Dysentery

Condition Hierarchy (Ancestors)

Gastroenteritis; Gastrointestinal Diseases; Digestive System Diseases; Intestinal Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed

Results Point of Contact

• Title: Dr. Andrew Meltzer
• Organization: George Washington University

ameltzer@mfa.gwu.edu

202-741-2952

Study Officials

• Andrew Meltzer, MD, MS

  The George Washington University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor of Emergency Medicine

Study Record Dates

• First Submitted: November 13, 2018
• First Posted: January 18, 2019
• Study Start: November 19, 2018
• Primary Completion: March 15, 2020
• Study Completion: September 7, 2020
• Last Updated: December 20, 2022
• Results First Posted: December 20, 2022

Record last verified: 2022-11

Locations

US (1)