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

NCT03809117 — Not applicable, Terminated, 74 participants, Andrew Meltzer

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A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department

Registry	NCT03809117
Status	Terminated - Study was halted due to obstacles faced in executing clinical procedures as a result of the COVID-19 pandemic.
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: none, treatment
Enrollment	74 (Actual)
Sponsor	Andrew Meltzer (Other); collaborators: BioFire Diagnostics, LLC
Conditions	Infectious Diarrhea
Interventions	Biofire Film Array Gastrointestinal Panel (Diagnostic test)
Dates	start 2018-11-19, primary completion 2020-03-15, completion 2020-09-07, first posted 2019-01-18, last updated 2022-12-20
Locations	1 site in United States

-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.

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+Arms and interventions

Arm	Type	Interventions	Description
Experimental	Experimental	Diagnostic Test: Biofire Film Array Gastrointestinal Panel	Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Control	Active comparator	Diagnostic Test: Biofire Film Array Gastrointestinal Panel	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.

Biofire Film Array Gastrointestinal Panel (Diagnostic test): 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.

+Outcome measures

Primary outcomes

Number of Participants With Optimal Antibiotic Chosen [30 Days post ED Discharge]: 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.

Secondary outcomes

ED Length of Stay [30 Days post ED Discharge]: Time from patient arrival to time when patient is officially discharged or admitted
Hospital Admission Rate [30 Days post ED Discharge]
Rate of Abdominal/Pelvic CT Scans [30 Days post ED Discharge]

+Eligibility

Sex: All, ages: 18 Years to any

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

+Posted results

Participant flow

Milestone	Experimental	Control
Started	38	36
Completed	38	36
Not completed	0	0

Outcome results

Number of Participants With Optimal Antibiotic Chosen (Primary), Count of participants, Participants: Experimental 13; Control 8
ED Length of Stay (Secondary), Median, hours: Experimental 7.68 (6.43 to 10.67); Control 8.15 (5.90 to 11.23)
Hospital Admission Rate (Secondary), Count of participants, Participants: Experimental 7; Control 3
Rate of Abdominal/Pelvic CT Scans (Secondary), Count of participants, Participants: Experimental 8; Control 8

Adverse events

Time frame: Day 7 and Day 30

Arm	Deaths	Serious adverse events	Other adverse events
Experimental	0/38 (0.0%)	0/38 (0.0%)	0/38 (0.0%)
Control	0/36 (0.0%)	0/36 (0.0%)	0/36 (0.0%)

Limitations and caveats: Early termination leading to small numbers of subjects analyzed

+Locations (1)

Facility	City	Country	Status
The George Washington University, Department of Emergency Medicine	Washington D.C., District of Columbia	United States

+Study documents

Study Protocol and Statistical Analysis Plan (PDF, 2020-09-09)
Informed Consent Form (PDF, 2020-03-09)

+Investigators

Andrew Meltzer, MD, MS, Principal investigator, The George Washington University

My Notes

Public

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