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Study was halted due to obstacles faced in executing clinical procedures as a result of the COVID-19 pandemic.
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| Name | Class |
|---|---|
| BioFire Diagnostics, LLC | INDUSTRY |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Experimental | Experimental | Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician. |
|
| Control | Active Comparator | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Biofire Film Array Gastrointestinal Panel | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 30 Days post ED Discharge |
| Measure | Description | Time Frame |
|---|---|---|
| ED Length of Stay | Time from patient arrival to time when patient is officially discharged or admitted | 30 Days post ED Discharge |
| Hospital Admission Rate | 30 Days post ED Discharge |
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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.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Andrew Meltzer, MD, MS | The George Washington University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The George Washington University, Department of Emergency Medicine | Washington D.C. | District of Columbia | 20037 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Count of Participants | Participants | 30 Days post ED Discharge |
|
Day 7 and Day 30
No adverse events were elicited at day 7 or day 30
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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Early termination leading to small numbers of subjects analyzed
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Meltzer | George Washington University | 202-741-2952 | ameltzer@mfa.gwu.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 9, 2020 | Sep 27, 2021 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Mar 9, 2020 | Aug 13, 2021 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D004403 | Dysentery |
| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |
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|
| Rate of Abdominal/Pelvic CT Scans | 30 Days post ED Discharge |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
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| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| OG001 |
| 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. |
|
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| Secondary | ED Length of Stay | Time from patient arrival to time when patient is officially discharged or admitted | Posted | Median | Inter-Quartile Range | hours | 30 Days post ED Discharge |
|
|
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| Secondary | Hospital Admission Rate | Posted | Count of Participants | Participants | 30 Days post ED Discharge |
|
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| Secondary | Rate of Abdominal/Pelvic CT Scans | Posted | Count of Participants | Participants | 30 Days post ED Discharge |
|
|
|
| 0 |
| 38 |
| 0 |
| 38 |
| 0 |
| 38 |
| EG001 | 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. | 0 | 36 | 0 | 36 | 0 | 36 |
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