Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
- Conditions
- Infectious Diarrhea
- 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
-
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.
- Symptoms greater than 24 hours;
- 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.))
- Inflammation (defined as fever (greater than 100.1), blood in stool per patient, DRE, or tenesmus.)
- 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
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
The George Washington University, Department of Emergency Medicine
🇺🇸Washington, District of Columbia, United States
The George Washington University, Department of Emergency Medicine🇺🇸Washington, District of Columbia, United States