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

Infectious Diarrhea Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03809117
• Other study ID #: IRB #051839
• Status: Terminated
• Phase: N/A
• Start date: November 19, 2018
• Est. completion date: September 7, 2020

Study information

• Verified date: November 2022
• Source: George Washington University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 74
• Est. completion date: September 7, 2020
• Est. primary completion date: March 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Diarrhea
• Dysentery
• Infections
• Infectious Diarrhea

Intervention

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.

Locations

Country	Name	City	State
United States	The George Washington University, Department of Emergency Medicine	Washington	District of Columbia

Sponsors (2)

Lead Sponsor	Collaborator
Andrew Meltzer	BioFire Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	ED Length of Stay	Time from patient arrival to time when patient is officially discharged or admitted	30 Days post ED Discharge
Secondary	Hospital Admission Rate		30 Days post ED Discharge
Secondary	Rate of Abdominal/Pelvic CT Scans		30 Days post ED Discharge