Infectious Diarrhea
Conditions
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.
Interventions
DIAGNOSTIC_TESTBiofire 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.
Sponsors
BioFire Diagnostics, LLC
Andrew Meltzer
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Experimental Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician.
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. | 38 |
| 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.
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. | 36 |
| Total | 74 |
Baseline characteristics
| Characteristic | Experimental | Control | Total |
|---|---|---|---|
| Age, Continuous | 34 years | 33 years | 34 years |
| Race/Ethnicity, Customized Race Asian, Native American, Other, Unknown | 7 Participants | 6 Participants | 13 Participants |
| Race/Ethnicity, Customized Race Black | 21 Participants | 21 Participants | 42 Participants |
| Race/Ethnicity, Customized Race White | 10 Participants | 9 Participants | 19 Participants |
| Sex: Female, Male Female | 23 Participants | 19 Participants | 42 Participants |
| Sex: Female, Male Male | 15 Participants | 17 Participants | 32 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 38 | 0 / 36 |
| other Total, other adverse events | 0 / 38 | 0 / 36 |
| serious Total, serious adverse events | 0 / 38 | 0 / 36 |
Outcome results
Primary
Number of Participants With Optimal Antibiotic Chosen
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.
Time frame: 30 Days post ED Discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Number of Participants With Optimal Antibiotic Chosen | 13 Participants |
| Control | Number of Participants With Optimal Antibiotic Chosen | 8 Participants |
Secondary
ED Length of Stay
Time from patient arrival to time when patient is officially discharged or admitted
Time frame: 30 Days post ED Discharge
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Experimental | ED Length of Stay | 7.68 hours |
| Control | ED Length of Stay | 8.15 hours |
Secondary
Hospital Admission Rate
Time frame: 30 Days post ED Discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Hospital Admission Rate | 7 Participants |
| Control | Hospital Admission Rate | 3 Participants |
Secondary
Rate of Abdominal/Pelvic CT Scans
Time frame: 30 Days post ED Discharge
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Experimental | Rate of Abdominal/Pelvic CT Scans | 8 Participants |
| Control | Rate of Abdominal/Pelvic CT Scans | 8 Participants |