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Completed

NCT Number: NCT02899065

Evaluation of the Roche 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.

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Key information

Age range

Up to 49 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of California, Davis Medical Center

Sacramento, California, 95817, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

procalcitonin

Diagnostic 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 Education

Other

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.

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Emergency Department Recidivism

    Time frame: 30 days

    Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV

  2. Symptom Resolution

    Time frame: 7 days and again at week 4

    Time to resolution of symptoms such as fever, cough or sore throat

  3. Lost Days of School/Work

    Time frame: 7 days and again at week 4

    Number of days of school and/or work missed due to illness

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Collaborators

  • Roche Pharma AG

Registry information

Official study title

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

Acronym: Influenza

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Sep 14, 2016
Registry last updated
Oct 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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