Influenza-Like IllnessFluProcessNCT02979730
Impact of Rapid Flu Testing in BMC ED
A study testing Core Lab Test and ED Point of Care Test in people with Influenza-Like Illness and Influenza, run by Boston Medical Center at 1 site in United States.
Trial summary
The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Influenza-Like Illness, Influenza
- What is being tested?
- Core Lab Test and ED Point of Care Test
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 233 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2017to 1 Dec 2017
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients 21 years of age or older
- Presenting to the BMC main ED or Urgent Care area with influenza-like illness
- Physician ordered an influenza A/B diagnostic test
Who cannot join
- Previously enrolled in the study
- Any Influenza test result already available at the time approached by the ED RA
- Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
- Unable to give informed consent
Trial locations and contacts
1 site in 1 country.
United States1 site
Boston University Medical Center
Boston, Massachusetts, 02118
About this study
Official title: Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center
The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing
- Conditions
- Influenza-Like Illness, Influenza
- Being tested
- Core Lab Test, ED Point of Care Test
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Core Lab TestOther
For patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab.
ED Point of Care TestOther
For patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay
| Study group | Role | What they receive |
|---|---|---|
| Core Lab Testing Arm | Active comparator | For patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays. The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.). Which test is ordered is at the discretion of the physician. Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B. Receives: Other: Core Lab Test |
| ED Point of Care Testing Arm | Experimental | Prior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC. The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm. The Cobas Liat assay provides a result callout to distinguish influenza type A from type B. Receives: Other: ED Point of Care Test |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to Disposition
The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record
Measured: By the End of the ED visit (an average time of 4 hours)
Secondary outcomes (1)
Delivery of prescription or administration of antibiotics
Whether patients either received a dose of antibiotics in the ED or received a prescription for antibiotics on discharge from the eD
Measured: by the end of ED visit (an average time of 4 hours)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2016 (estimated)
- Study start7 Feb 2017
- Primary completion1 Dec 2017
- Study completion1 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Influenza-Like IllnessStudies of the same condition, open and under way.
- More trials run by Boston Medical CenterThe sponsor's other registered studies.
- 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 233 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elissa Schechter-Perkins, Boston Medical Center
- Investigators
- Elissa Perkins, MD, MPH, Principal investigator, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02979730
- Sponsor's protocol ID
- H-35841
- Acronym
- FluProcess
- Status last verified
- Jul 2018
- First submitted
- 22 Nov 2016
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Proposal to Evaluate the Impact of Point of Care Liat Influenza A/B Testing in the Emergency Department at Boston Medical Center
- ClinicalTrials.gov ID
- NCT02979730
- Acronym / sponsor ID
- FluProcess / H-35841
- Conditions
- Influenza-Like Illness, Influenza
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 233 participants (actual)
- Lead sponsor
- Boston Medical CenterUniversity, hospital or other
- Study start
- 7 Feb 2017 (actual)
- Primary completion
- 1 Dec 2017 (actual)
- Study completion
- 1 Dec 2017 (actual)
- First posted
- 2 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the study is to compare Emergency Department patients who undergo influenza testing using an FDA-approved point-of-care device (Cobas Liat Influenza A/B assay) located in the ED, to patients whose samples are sent to the BMC central laboratory. Patients who agree to participate will have their samples randomly assigned to be tested on either at the core lab, or on the POC device. The current turnaround time for samples sent to the laboratory is approximately two hours; investigators expect that the point of care device can reduce this time. Investigators will determine if the time to disposition and the administration of antibiotics is different in the group undergoing POC influenza testing compared to those undergoing laboratory-based influenza testing
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Core Lab Testing Arm | Active comparator | Other: Core Lab TestFor patients with clinical concern for influenza, the usual workflow in the BMC ED is that physicians order the collection of a nasopharyngeal swab (NPS) for influenza A/B testing to be performed in the core microbiology laboratory using one of two assays. The two influenza A/B-only assays available in the core lab are a) an instrumented fluorescent immunoassay rapid antigen test, the Sofia influenza A+B FIA (Quidel Corporation) and b) an automated real-time PCR test, the Xpert Flu (Cepheid, Inc.). Which test is ordered is at the discretion of the physician. Both the Sofia and Xpert assays provide a result callout to distinguish influenza type A from type B. |
| ED Point of Care Testing Arm | Experimental | Other: ED Point of Care TestPrior to the study the Cobas Liat Influenza A/B assay will be verified for patient care at BMC. The instrument and test kits will be available in the ED for use with study subjects randomized to this study arm. The Cobas Liat assay provides a result callout to distinguish influenza type A from type B. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult patients 21 years of age or older
- Presenting to the BMC main ED or Urgent Care area with influenza-like illness
- Physician ordered an influenza A/B diagnostic test
Key exclusion criteria (4 listed)
- Previously enrolled in the study
- Any Influenza test result already available at the time approached by the ED RA
- Physician ordered comprehensive multiplex PCR respiratory pathogen assay instead of an initial influenza A/B-only test.
- Unable to give informed consent
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 |
|---|---|---|
| Core Lab TestFor patients randomized to the Core Lab Testing Arm, ED physicians will order an influenza test to be performed in the core lab. | Other | Core Lab Testing Arm |
| ED Point of Care TestFor patients randomized to the ED Point of Care Testing Arm, the Research Assistant will perform influenza testing in the Emergency Department, using the Cobas Liat Influenza A/B assay | Other | ED Point of Care Testing Arm |
Primary outcome
Time to Disposition
Time frame: By the End of the ED visit (an average time of 4 hours)
The time elapsed from when a patient was placed in the ED treatment room until the disposition (either admit, observe, or discharge) was ordered in the medical record
1 secondary outcome
Delivery of prescription or administration of antibiotics
Time frame: by the end of ED visit (an average time of 4 hours)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Individual participant dataSharing planned: No
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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.
Elissa Perkins, MD, MPH principal investigator
Boston 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 Core Lab Test and ED Point of Care Test in people with Influenza-Like Illness and Influenza, run by Boston Medical Center 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 3 inclusion and 4 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: finished, as of the sponsor's last update on 24 Jul 2018. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Time to Disposition (time frame: By the End of the ED visit (an average time of 4 hours)). 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 24 Jul 2018.