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Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea | Clinical Trials | Clareo Health

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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

NCT03809117•Andrew Meltzer

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

The George Washington University, Department of Emergency Medicine

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

Key Dates

Start Date

November 19, 2018

Primary Completion Date

March 15, 2020

Completion Date

September 7, 2020

Last Updated

December 20, 2022

Enrollment

ACTUAL participants

Conditions

Infectious Diarrhea

Interventions

Biofire Film Array Gastrointestinal Panel

DIAGNOSTIC_TEST

Lactobacillus Acidophilus and Limosilactobacillus Reuteri for Acute Diarrhea in Children

NCT07342088

Infectious DiarrheaAcute Gastroenteritis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: December 20, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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