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

Not Applicable
Terminated
Conditions
Infectious Diarrhea
Interventions
Diagnostic Test: Biofire Film Array Gastrointestinal Panel
Registration Number
NCT03809117
Lead Sponsor
Andrew Meltzer
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 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.

Detailed Description

Not available

Recruitment & Eligibility

Status
TERMINATED
Sex
All
Target Recruitment
74
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

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
ControlBiofire Film Array Gastrointestinal PanelGastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician.
ExperimentalBiofire Film Array Gastrointestinal PanelGastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
Primary Outcome Measures
NameTimeMethod
Number of Participants With Optimal Antibiotic Chosen30 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 Outcome Measures
NameTimeMethod
Hospital Admission Rate30 Days post ED Discharge
ED Length of Stay30 Days post ED Discharge

Time from patient arrival to time when patient is officially discharged or admitted

Rate of Abdominal/Pelvic CT Scans30 Days post ED Discharge

Trial Locations

Locations (1)

The George Washington University, Department of Emergency Medicine

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Washington, District of Columbia, United States

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