MedTrace Logo

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

NCT03809117 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 74

Last updated 2022-12-20

Study results available
· View outcomes & findings →

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

Interventions

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.

Sponsors & Collaborators

  • BioFire Diagnostics, LLC

    collaborator INDUSTRY

  • Andrew Meltzer

    lead OTHER

Principal Investigators

  • Andrew Meltzer, MD, MS · The George Washington University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-19
Primary Completion
2020-03-15
Completion
2020-09-07
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03809117 on ClinicalTrials.gov