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

Andrew Meltzer

Status: Terminated

Conditions: Infectious Diarrhea

Treatments: Diagnostic Test: Biofire Film Array Gastrointestinal Panel

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03809117

IRB #051839

Details and patient eligibility

About

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.

Enrollment: 74 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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74 participants in 2 patient groups

Experimental

Experimental group

Description:

Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.

Treatment:

Diagnostic Test: Biofire Film Array Gastrointestinal Panel

Control

Active Comparator group

Description:

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.

Treatment:

Diagnostic Test: Biofire Film Array Gastrointestinal Panel