An interventional study of Biofire Film Array Gastrointestinal Panel in Infectious Diarrhea, sponsored by Andrew Meltzer. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-12-20.
Sponsored by Andrew Meltzer · Not applicable, Interventional, and Treatment
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.
Must have one of the 3 following features or symptoms lasting more than 7 days.
Exclusion Criteria:
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
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.
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
ED Length of Stay
Time from patient arrival to time when patient is officially discharged or admitted
Time frame: 30 Days post ED Discharge
Hospital Admission Rate
Time frame: 30 Days post ED Discharge
Rate of Abdominal/Pelvic CT Scans
Time frame: 30 Days post ED Discharge
| Milestone | Experimental | Control |
|---|---|---|
| Started | 38 | 36 |
| Completed | 38 | 36 |
| Not completed | 0 | 0 |
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.
| Participants | Experimental | Control |
|---|---|---|
| Number of Participants With Optimal Antibiotic Chosen | 13 | 8 |
Time from patient arrival to time when patient is officially discharged or admitted
| hours | Experimental | Control |
|---|---|---|
| ED Length of Stay | 7.68 (6.43 to 10.67) | 8.15 (5.90 to 11.23) |
| Participants | Experimental | Control |
|---|---|---|
| Hospital Admission Rate | 7 | 3 |
| Participants | Experimental | Control |
|---|---|---|
| Rate of Abdominal/Pelvic CT Scans | 8 | 8 |
Collected over Day 7 and Day 30. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Experimental | 0/38 (0%) | 0/38 (0%) | 0/38 (0%) |
| Control | 0/36 (0%) | 0/36 (0%) | 0/36 (0%) |
| Age, Continuous(years) | Experimental | Control | Total |
|---|---|---|---|
| Median | 34 (26 to 51.25) | 33 (25.75 to 52.25) | 34 (26 to 52.75) |
| Sex: Female, Male(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Female | 23 | 19 | 42 |
| Male | 15 | 17 | 32 |
| Race/Ethnicity, Customized(Participants) | Experimental | Control | Total |
|---|---|---|---|
| Race — Black | 21 | 21 | 42 |
| Race — White | 10 | 9 | 19 |
| Race — Asian, Native American, Other, Unknown | 7 | 6 | 13 |
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This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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