Infectious DiarrheaNCT03809117
Film Array Gastrointestinal Panel Compared to Usual Care for ED Evaluation of Infectious Diarrhea
A study testing Biofire Film Array Gastrointestinal Panel in people with Infectious Diarrhea, run by Andrew Meltzer at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infectious Diarrhea
- What is being tested?
- Biofire Film Array Gastrointestinal Panel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Nov 2018to 7 Sep 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.)
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
The George Washington University, Department of Emergency Medicine
Washington D.C., District of Columbia, 20037
About this study
Official title: A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department
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.
- Conditions
- Infectious Diarrhea
- Being tested
- Biofire Film Array Gastrointestinal Panel
- Medical subject headings
- Dysentery
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Biofire Film Array Gastrointestinal PanelDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | Gastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician. Receives: Diagnostic Test: Biofire Film Array Gastrointestinal Panel |
| 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. Receives: Diagnostic Test: Biofire Film Array Gastrointestinal Panel |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 Days post ED Discharge
Secondary outcomes (3)
ED Length of Stay
Time from patient arrival to time when patient is officially discharged or admitted
Measured: 30 Days post ED Discharge
Hospital Admission Rate
Measured: 30 Days post ED Discharge
Rate of Abdominal/Pelvic CT Scans
Measured: 30 Days post ED Discharge
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jan 2019
- Study start19 Nov 2018
- Primary completion15 Mar 2020
- Study completion7 Sep 2020
Why it stopped: Study was halted due to obstacles faced in executing clinical procedures as a result of the COVID-19 pandemic.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Infectious DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Andrew Meltzer
- Sponsor type
- University, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Responsible party
- Sponsor-investigator, Andrew Meltzer, George Washington University
- Investigators
- Andrew Meltzer, MD, MS, Principal investigator, The George Washington University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03809117
- Sponsor's protocol ID
- IRB #051839
- Status last verified
- Nov 2022
- First submitted
- 13 Nov 2018
- Last updated
- 20 Dec 2022
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Controlled Trial of Biofire Film Array Gastrointestinal Panel Compared to Usual Care for Evaluation of Acute Infectious Diarrhea in the Emergency Department
- ClinicalTrials.gov ID
- NCT03809117
- Acronym / sponsor ID
- IRB #051839
- Conditions
- Infectious Diarrhea
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study was halted due to obstacles faced in executing clinical procedures as a result of the COVID-19 pandemic.
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Andrew MeltzerUniversity, hospital or other
- Collaborators
- BioFire Diagnostics, LLC
- Study start
- 19 Nov 2018 (actual)
- Primary completion
- 15 Mar 2020 (actual)
- Study completion
- 7 Sep 2020 (actual)
- First posted
- 18 Jan 2019 (actual)
- Results
- Posted 20 Dec 2022
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Diagnostic Test: Biofire Film Array Gastrointestinal PanelGastrointestinal Polymerase Chain Reaction test performed and results communicated to treatment provider. Followed by usual care per treating physician. |
| Control | Active comparator | Diagnostic Test: Biofire Film Array Gastrointestinal PanelGastrointestinal Polymerase Chain Reaction test performed at the conclusion of the study. Clinician will not be informed of results. Usual Care performed per treating physician. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Biofire Film Array Gastrointestinal PanelThe 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. | Diagnostic test | Control, Experimental |
Primary outcome
Number of Participants With Optimal Antibiotic Chosen
Time frame: 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.
3 secondary outcomes
ED Length of Stay
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
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2022.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Related trials for Infectious Diarrhea
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Natural History of Clostridioides Difficile Infection
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Evaluating the LGG of on Acute Infectious Diarrhea in Children
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Meltzer, MD, MS principal investigator
The George Washington University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Biofire Film Array Gastrointestinal Panel in people with Infectious Diarrhea, run by Andrew Meltzer at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 20 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Dec 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants With Optimal Antibiotic Chosen (time frame: 30 Days post ED Discharge). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Dec 2022.