NCT02899065

Evaluation of the Roche Liat Flu/RSV Assay for Management of Influenza in the Emergency Department

Evaluation of the Roche Cobas Liat Flu/RSV Assay for Management of Influenza in the Emergency Department

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: University of California, Davis · Academic / Other
• Sex: All
• Age: 49 Years
• Healthy volunteers: Not accepted

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.

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

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Procalcitonin	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.
OTHER	Pharmacist-Led Education	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.

Timeline

• Start date: 2018-03-06
• Primary completion: 2022-04-15
• Completion: 2022-05-20
• First posted: 2016-09-14
• Last updated: 2023-10-17
• Results posted: 2023-10-17

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study