Influenza, HumanInfluenzaNCT02899065
Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
A study testing Procalcitonin and Pharmacist-Led Education in people with Influenza, Human, run by University of California, Davis at 1 site in United States.
Trial summary
This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate (in aggregate) both the use of the Roche Cobas Liat Flu/RSV Assay and the use of pharmacist-led education for providers in the interpretation of these test results. Read more about this study
- Who is it for?
- Ages Up to 49 years
- Conditions the study is for
- Influenza, Human
- What is being tested?
- Procalcitonin and Pharmacist-Led Education
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Mar 2018to 20 May 2022
- 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 Up to 49 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Patients <50 years of age who are evaluated in the emergency department for:
- suspected influenza, including symptoms of influenza-like illness (ILI - including fever > 38 degrees Celsius and cough or sore throat), or
- non-specific upper respiratory infection (URI) for whom the clinician suspects the presence of RSV, or influenza, or lower respiratory infection LRI).
- Patients whose treating provider has ordered a Roche Cobas Liat Flu/RSV test.
Who cannot join
- Patients who are pregnant
- Prisoners
- Patients who are unable to give informed consent in English or Spanish.
- Provider is unwilling to wait for procalcitonin results.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of California, Davis Medical Center
Sacramento, California, 95817
About this study
Official title: Evaluation of the Roche Cobas Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate (in aggregate) both the use of the Roche Cobas Liat Flu/RSV Assay and the use of pharmacist-led education for providers in the interpretation of these test results.
Read the detailed description
To determine if pharmacist-led education and procalcitonin testing as part of a stewardship intervention optimizes antiviral treatment and reduces antibiotic treatment for pediatric Emergency Department (ED) patients with suspected influenza v. standard care (i.e. rapid molecular influenza test without patient specific treatment recommendations) using a prospective, patient-randomized design.
Consented patients in the pediatric ED will be randomized into two arms: The intervention arm will receive a patient specific stewardship intervention and procalcitonin testing during the ED visit. The intervention will be pharmacist-led and include direct delivery to clinicians of information about interpreting test results and recommendations for antiviral-treatment for high-risk patients, and infection control precautions for patients being hospitalized with a positive RSV or influenza test. Clinician adherence to treatment guidelines with and without the educational intervention will be compared.
The second arm will be usual care (i.e. no procalcitonin test or pharmacist-led education). Results will be delivered via standard of care through the electronic medical record (EMR).
Physicians and patients will not be blinded to arm assignments. Tests will be performed on a real-time basis in the ED. For each of these groups, data of the frequency and duration of antibiotic administration, antiviral use, adherence to evidence based guidelines for treatment of influenza, isolation, hospitalizations, and unscheduled return visits or readmissions within a 30 day period will be collected and compared.
Research coordinators will contact patients and/or parents at 1 and 4 weeks after enrollment for self-reported secondary outcomes including symptom resolution, return to school/work, and follow up healthcare visits, medication adherence (to antibiotics and/or antivirals), and adverse events.
- Conditions
- Influenza, Human
- Being tested
- Procalcitonin, Pharmacist-Led Education
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ProcalcitoninDiagnostic test
Procalcitonin is a blood test used to differentiate between viral and bacterial infections. This test is expected to aid in determining the best course of treatment for patients enrolled into this arm.
Pharmacist-Led EducationOther
Pharmacists will interpret the results of the Roche Cobas Liat Flu/RSV assay and procalcitonin test (if available) and provide the treating physician with recommendations for antibiotic therapy based on these results.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | The intervention arm will receive pharmacist-led education and stewardship intervention and a procalcitonin test to aid in the decision of how to treat the patient. This intervention will include direct delivery of education from the pharmacist to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test. Receives: Diagnostic Test: Procalcitonin; Other: Pharmacist-Led Education |
| Standard of care | No intervention | The second arm will be usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results will be delivered via standard of care. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Participants Prescribed Antibiotics
The determination of whether use of the Roche Cobas/Liat Flu/RSV Assay as part of a stewardship intervention reduces antibiotic treatment for pediatric ED patients with suspected influenza. Proper adherence to treatment guidelines after results should reduce physician prescription of antibiotic for non-responsive conditions.
Measured: During ED stay, up to 48 hours
Number of Participants Prescribed Antiviral Therapy
The determination of whether use of the Roche Cobas Liat Flu/RSV Assay as part of a formal stewardship intervention optimizes antiviral treatment of pediatric ED patients with influenza at risk of complications.
Measured: During ED stay, up to 48 hours
Secondary outcomes (3)
Emergency Department Recidivism
Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV
Measured: 30 days
Symptom Resolution
Time to resolution of symptoms such as fever, cough or sore throat
Measured: 7 days and again at week 4
Lost Days of School/Work
Number of days of school and/or work missed due to illness
Measured: 7 days and again at week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2016 (estimated)
- Study start6 Mar 2018
- Primary completion15 Apr 2022
- Study completion20 May 2022
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 Influenza, HumanStudies of the same condition, open and under way.
- More trials run by University of California, DavisThe 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of California, Davis
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Pharma AG
- Responsible party
- Sponsor
- Investigators
- Larissa S May, MD, Principal investigator, University of California, Davis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02899065
- Sponsor's protocol ID
- 906232
- Acronym
- Influenza
- Status last verified
- Sep 2023
- First submitted
- 2 Aug 2016
- Last updated
- 17 Oct 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Roche Cobas Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
- ClinicalTrials.gov ID
- NCT02899065
- Acronym / sponsor ID
- Influenza / 906232
- Conditions
- Influenza, Human
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- University of California, DavisUniversity, hospital or other
- Collaborators
- Roche Pharma AG
- Study start
- 6 Mar 2018 (actual)
- Primary completion
- 15 Apr 2022 (actual)
- Study completion
- 20 May 2022 (actual)
- First posted
- 14 Sep 2016 (estimated)
- Results
- Posted 17 Oct 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This will be a prospective, patient-oriented, pilot randomized clinical trial to evaluate (in aggregate) both the use of the Roche Cobas Liat Flu/RSV Assay and the use of pharmacist-led education for providers in the interpretation of these test results.
Detailed description
To determine if pharmacist-led education and procalcitonin testing as part of a stewardship intervention optimizes antiviral treatment and reduces antibiotic treatment for pediatric Emergency Department (ED) patients with suspected influenza v. standard care (i.e. rapid molecular influenza test without patient specific treatment recommendations) using a prospective, patient-randomized design.
Consented patients in the pediatric ED will be randomized into two arms: The intervention arm will receive a patient specific stewardship intervention and procalcitonin testing during the ED visit. The intervention will be pharmacist-led and include direct delivery to clinicians of information about interpreting test results and recommendations for antiviral-treatment for high-risk patients, and infection control precautions for patients being hospitalized with a positive RSV or influenza test. Clinician adherence to treatment guidelines with and without the educational intervention will be compared.
The second arm will be usual care (i.e. no procalcitonin test or pharmacist-led education). Results will be delivered via standard of care through the electronic medical record (EMR).
Physicians and patients will not be blinded to arm assignments. Tests will be performed on a real-time basis in the ED. For each of these groups, data of the frequency and duration of antibiotic administration, antiviral use, adherence to evidence based guidelines for treatment of influenza, isolation, hospitalizations, and unscheduled return visits or readmissions within a 30 day period will be collected and compared.
Research coordinators will contact patients and/or parents at 1 and 4 weeks after enrollment for self-reported secondary outcomes including symptom resolution, return to school/work, and follow up healthcare visits, medication adherence (to antibiotics and/or antivirals), and adverse events.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Diagnostic Test: Procalcitonin, Other: Pharmacist-Led EducationThe intervention arm will receive pharmacist-led education and stewardship intervention and a procalcitonin test to aid in the decision of how to treat the patient. This intervention will include direct delivery of education from the pharmacist to the treating clinician about interpreting the Roche Cobas Liat Flu/RSV and procalcitonin test results, recommendations for antiviral-treatment for high-risk patients and information about infection control precautions for patients being hospitalized with a positive RSV or influenza test. |
| Standard of care | No intervention | –The second arm will be usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results will be delivered via standard of care. |
Who may qualify
- Ages
- Up to 49 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Patients <50 years of age who are evaluated in the emergency department for:
- suspected influenza, including symptoms of influenza-like illness (ILI - including fever > 38 degrees Celsius and cough or sore throat), or
- non-specific upper respiratory infection (URI) for whom the clinician suspects the presence of RSV, or influenza, or lower respiratory infection LRI).
- Patients whose treating provider has ordered a Roche Cobas Liat Flu/RSV test.
Key exclusion criteria (4 listed)
- Patients who are pregnant
- Prisoners
- Patients who are unable to give informed consent in English or Spanish.
- Provider is unwilling to wait for procalcitonin results.
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 |
|---|---|---|
| ProcalcitoninProcalcitonin is a blood test used to differentiate between viral and bacterial infections. This test is expected to aid in determining the best course of treatment for patients enrolled into this arm. | Diagnostic test | Intervention |
| Pharmacist-Led EducationPharmacists will interpret the results of the Roche Cobas Liat Flu/RSV assay and procalcitonin test (if available) and provide the treating physician with recommendations for antibiotic therapy based on these results. | Other | Intervention |
Primary outcome
Number of Participants Prescribed Antibiotics
Time frame: During ED stay, up to 48 hours
The determination of whether use of the Roche Cobas/Liat Flu/RSV Assay as part of a stewardship intervention reduces antibiotic treatment for pediatric ED patients with suspected influenza. Proper adherence to treatment guidelines after results should reduce physician prescription of antibiotic for non-responsive conditions.
Number of Participants Prescribed Antiviral Therapy
Time frame: During ED stay, up to 48 hours
The determination of whether use of the Roche Cobas Liat Flu/RSV Assay as part of a formal stewardship intervention optimizes antiviral treatment of pediatric ED patients with influenza at risk of complications.
3 secondary outcomes
Emergency Department Recidivism
Time frame: 30 days
Symptom Resolution
Time frame: 7 days and again at week 4
Lost Days of School/Work
Time frame: 7 days and again at week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Oct 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Learn more or sign up for the study here!Link provided by the sponsor.
- 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.
Larissa S May, MD principal investigator
University of California, Davis
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Procalcitonin and Pharmacist-Led Education in people with Influenza, Human, run by University of California, Davis 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 4 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 17 Oct 2023. 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 17 Oct 2023). 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 Prescribed Antibiotics (time frame: During ED stay, up to 48 hours). The study lists 2 primary outcomes in all. 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 17 Oct 2023.