Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
Study Details
Study Description
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 |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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.
|
Outcome Measures
Primary Outcome Measures
- Rate of Optimal Use of Antibiotics [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
- Time to Resolution of Symptoms/Clinical Improvement [30 Days post ED Discharge]
- Rate of appropriate use of anti-motility medications [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.
- Rate of stool sample collection in triage and emergency department visit [30 Days post ED Discharge]
- Diagnostic Yield at time of ED discharge [30 Days post ED Discharge]
Defined as positive identification of a pathogen as a result of stool testing
- Diagnostic Yield at 72 hours post ED Discharge [30 Days post ED Discharge]
Defined as positive identification of a pathogen as a result of stool testing
- 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]
- Patient Satisfaction [30 Days post ED Discharge]
To be assessed from relevant HCAHPS Survey Questions
- Rate of abdominal/pelvic CT scans [30 Days post ED Discharge]
- Rates of Emergency Department return visits or readmission [30 Days post ED Discharge]
- Turnaround time [30 Days post ED Discharge]
Defined as time from sample collection to when test results are available to the clinician
Eligibility Criteria
Criteria
Inclusion Criteria:
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Presumed infectious diarrhea (3 or more loose stools in past 24 hours)
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Must have one of the 3 following features or symptoms lasting more than 7 days.
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Symptoms greater than 24 hours;
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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.))
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Inflammation (defined as fever (greater than 100.1), blood in stool per patient, DRE, or tenesmus.)
Exclusion Criteria:
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Chronic Symptoms (>14 days)
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Inability to Follow- Up (i.e. no telephone)
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Prisoner
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Likely non-infectious cause of diarrhea (Crohn's disease, radiation colitis, irritable bowel syndrome, or celiac disease)
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Confirmed C. Diff Diarrhea
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Unable to provide written consent
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Non- English speaker
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The George Washington University, Department of Emergency Medicine | Washington | District of Columbia | United States | 20037 |
Sponsors and Collaborators
- Andrew Meltzer
- BioFire Diagnostics, LLC
Investigators
- Principal Investigator: Andrew Meltzer, MD, MS, The George Washington University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- IRB #051839