Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
Influenza
Evaluation of the Roche Cobas Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
1 other identifier
interventional
200
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Mar 2018
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
August 2, 2016
CompletedFirst Posted
Study publicly available on registry
September 14, 2016
CompletedStudy Start
First participant enrolled
March 6, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 15, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
May 20, 2022
CompletedResults Posted
Study results publicly available
October 17, 2023
CompletedOctober 17, 2023
September 1, 2023
4.1 years
August 2, 2016
June 20, 2023
September 28, 2023
Conditions
Outcome Measures
Primary Outcomes (2)
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.
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.
During ED stay, up to 48 hours
Secondary Outcomes (3)
Emergency Department Recidivism
30 days
Symptom Resolution
7 days and again at week 4
Lost Days of School/Work
7 days and again at week 4
Study Arms (2)
Intervention
EXPERIMENTALThe 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 INTERVENTIONThe second arm will be usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results will be delivered via standard of care.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of California, Davislead
- Roche Pharma AGcollaborator
Study Sites (1)
University of California, Davis Medical Center
Sacramento, California, 95817, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Larissa May, MD, MSHS, MSPH, Director of Emergency Medicine Innovation and External Partnerships
- Organization
- UC Davis Medical Center
Study Officials
- PRINCIPAL INVESTIGATOR
Larissa S May, MD
University of California, Davis
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- HEALTH SERVICES RESEARCH
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
August 2, 2016
First Posted
September 14, 2016
Study Start
March 6, 2018
Primary Completion
April 15, 2022
Study Completion
May 20, 2022
Last Updated
October 17, 2023
Results First Posted
October 17, 2023
Record last verified: 2023-09
Data Sharing
- IPD Sharing
- Will not share