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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03809117
Recruitment Status : Recruiting
First Posted : January 18, 2019
Last Update Posted : January 18, 2019
Sponsor:
Collaborator:
BioFire Diagnostics, LLC
Information provided by (Responsible Party):
Andrew Meltzer, George Washington University

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.


Condition or disease Intervention/treatment Phase
Infectious Diarrhea Diagnostic Test: Biofire Film Array Gastrointestinal Panel Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 176 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 19, 2018
Estimated Primary Completion Date : August 19, 2019
Estimated Study Completion Date : November 19, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Diarrhea

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

Active Comparator: Control
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.
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.




Primary Outcome Measures :
  1. Rate of Optimal Use of Antibiotics [ Time Frame: 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 Outcome Measures :
  1. Time to Resolution of Symptoms/Clinical Improvement [ Time Frame: 30 Days post ED Discharge ]
  2. Rate of appropriate use of anti-motility medications [ Time Frame: 30 Days post ED Discharge ]
    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.

  3. Rate of stool sample collection in triage and emergency department visit [ Time Frame: 30 Days post ED Discharge ]
  4. Diagnostic Yield at time of ED discharge [ Time Frame: 30 Days post ED Discharge ]
    Defined as positive identification of a pathogen as a result of stool testing

  5. Diagnostic Yield at 72 hours post ED Discharge [ Time Frame: 30 Days post ED Discharge ]
    Defined as positive identification of a pathogen as a result of stool testing

  6. ED Length of Stay [ Time Frame: 30 Days post ED Discharge ]
    Time from patient arrival to time when patient is officially discharged or admitted

  7. Hospital Admission Rate [ Time Frame: 30 Days post ED Discharge ]
  8. Patient Satisfaction [ Time Frame: 30 Days post ED Discharge ]
    To be assessed from relevant HCAHPS Survey Questions

  9. Rate of abdominal/pelvic CT scans [ Time Frame: 30 Days post ED Discharge ]
  10. Rates of Emergency Department return visits or readmission [ Time Frame: 30 Days post ED Discharge ]
  11. Turnaround time [ Time Frame: 30 Days post ED Discharge ]
    Defined as time from sample collection to when test results are available to the clinician



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03809117


Contacts
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Contact: Andrew C Meltzer, MD, MS 202-741-2952 ameltzer@mfa.gwu.edu
Contact: Maxine LeSaux 202-741-2917 mlesaux@mfa.gwu.edu

Locations
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United States, District of Columbia
The George Washington University, Department of Emergency Medicine Recruiting
Washington, District of Columbia, United States, 20037
Contact: Andrew C Meltzer, MD, MS    202-741-2952    ameltzer@mfa.gwu.edu   
Contact: Maxine LeSaux    202-741-2917    mlesaux@mfa.gwu.edu   
Principal Investigator: Andrew C Meltzer, MD, MS         
Sponsors and Collaborators
Andrew Meltzer
BioFire Diagnostics, LLC
Investigators
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Principal Investigator: Andrew Meltzer, MD, MS The George Washington University
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Responsible Party: Andrew Meltzer, Associate Professor of Emergency Medicine, George Washington University
ClinicalTrials.gov Identifier: NCT03809117    
Other Study ID Numbers: IRB #051839
First Posted: January 18, 2019    Key Record Dates
Last Update Posted: January 18, 2019
Last Verified: January 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Communicable Diseases
Infection
Dysentery
Diarrhea
Signs and Symptoms, Digestive
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases
Intestinal Diseases