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

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ClinicalTrials.gov Identifier: NCT02899065
Recruitment Status : Recruiting
First Posted : September 14, 2016
Last Update Posted : April 29, 2021
Sponsor:
Collaborator:
Roche Pharma AG
Information provided by (Responsible Party):
University of California, Davis

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.

Condition or disease Intervention/treatment Phase
Influenza, Human Diagnostic Test: Procalcitonin Other: Pharmacist-Led Education Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Health Services Research
Official Title: Evaluation of the Roche Cobas Liat Flu/RSV Assay for Management of Influenza in the Emergency Department
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

Arm Intervention/treatment
Experimental: Intervention
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.
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.

No Intervention: Standard of care
The second arm will be usual care (i.e. Roche Cobas Liat Flu/RSV test only). Results will be delivered via standard of care.



Primary Outcome Measures :
  1. Treatment guideline adherence as measured by physician prescription of antibiotic non-responsive conditions [ Time Frame: Immediate ]
    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.

  2. Antiviral treatment for patients with influenza like illness at risk of complications [ Time Frame: immediate ]
    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 Outcome Measures :
  1. Physician adherence to Centers for Disease Control and Prevention (CDC) guidelines for treatment of influenza as measured by prescription of anti-viral treatment for patients in whom it is indicated. [ Time Frame: 2 years ]
    The investigators will monitor physician prescription of anti-viral therapy according to CDC guidelines, which would recommend anti-viral treatment of patients who will be hospitalized with complicated illness, patients who will be discharged home from the Emergency Department but are at increased risk for complications, and patients in whom test results would indicate appropriateness of anti-viral therapy.

  2. Emergency Department recidivism [ Time Frame: 30 days ]
    Emergency Department return visits within 30 days for patients diagnosed with influenza and RSV

  3. Symptom resolution [ Time Frame: 30 days ]
    Time to resolution of symptoms such as fever, cough or sore throat

  4. Lost days of school/work [ Time Frame: 30 days ]
    Number of days of school and/or work missed due to illness

  5. Healthcare burden as measured by the number of healthcare visits after discharge from the Emergency Department [ Time Frame: 30 days ]
    Subsequent healthcare utilization



Information from the National Library of Medicine

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Ages Eligible for Study:   up to 20 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02899065


Contacts
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Contact: Larissa S. May, MD 916-734-1593 lsmay@ucdavis.edu
Contact: Cindy V. Valencia, MPH 916-734-0373 cvvalencia@ucdavis.edu

Locations
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United States, California
University of California, Davis Medical Center Recruiting
Sacramento, California, United States, 95817
Contact: Larissa S. May, MD    916-734-1593    lsmay@ucdavis.edu   
Contact: Cindy V. Valencia, MPH    916-734-0373    cvvalencia@ucdavis.edu   
Sponsors and Collaborators
University of California, Davis
Roche Pharma AG
Investigators
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Principal Investigator: Larissa S May, MD University of California, Davis
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Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT02899065    
Other Study ID Numbers: 906232
First Posted: September 14, 2016    Key Record Dates
Last Update Posted: April 29, 2021
Last Verified: April 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Additional relevant MeSH terms:
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Influenza, Human
Emergencies
Respiratory Tract Infections
Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes