Evaluation of the Roche Cobas Liat Flu/Respiratory Syncytial Virus (RSV) Assay for Management of Influenza in the Emergency Department

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.

Inclusion Criteria:

- Patients <21 years of age who are evaluated in the emergency department for:

- suspected influenza, including symptoms of influenza-like illness (ILI - including
fever and cough or sore throat), or

- non-specific upper respiratory infection (URI) with suspicion for presence of RSV or
influenza.

- Patients whose treating provider has ordered a Roche Cobas Liat Flu/RSV test

Exclusion Criteria:

- Patients who are pregnant

- Prisoners

- Patients who are unable to give informed consent in English or Spanish.