Status:
TERMINATED
Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
Lead Sponsor:
Andrew Meltzer
Collaborating Sponsors:
BioFire Diagnostics, LLC
Conditions:
Infectious Diarrhea
Eligibility:
All Genders
18+ years
Phase:
NA
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...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 19 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 7 2020
Estimated Enrollment :
74 Patients enrolled
Trial Details
Trial ID
NCT03809117
Start Date
November 19 2018
End Date
September 7 2020
Last Update
December 20 2022
Active Locations (1)
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1
The George Washington University, Department of Emergency Medicine
Washington D.C., District of Columbia, United States, 20037