Treatment of Influenza and ARVI in Children by Kagocel ®
Condition: Influenza; Acute Upper Respiratory Infection
MeSH terms: Infections; Influenza, Human; Respiratory Tract Infections
Study type: Observational

Summary: 
      This study examined the etiology of acute respiratory viral infections (ARVI) during the
      2015-2016 season, evaluated the statistics of the incidence of influenza and ARVI in this
      period (epidemiology: severity of the disease and bacterial exacerbations; demographics of
      patients; duration and timing of treatment; safety; quality of treatment), and evaluated the
      effectiveness of complex therapy with an emphasis on the using of interferon inducers in
      hospitalized children aged 3 to 11 years.
    

Detailed description: 
      This non-interventional observational study included 80 patients aged 3 to 11 years who were
      hospitalized with influenza and acute respiratory viral infections (ARVI) symptoms at any
      time from the onset of the disease (up to 15 days) and who were prescribed the interferon
      inducer Kagocel as an antiviral medicine.

      The diagnosis of influenza and ARVI was confirmed in accordance with the world health
      organization (who) guidelines for the pharmacological treatment of pandemic influenza A
      (H1N1) 2009 and other influenza viruses.

      All patient examinations are conducted in accordance with local routine clinical practice and
      local and international standards of care.

      After the end of treatment, the following data were collected and analyzed:

        -  demography

        -  disease severity

        -  anamnesis data (data of influenza vaccination in the current season; pre-school
           facilities visits; previous contacts with a patient with influenza / ARVI; previous
           antiviral therapy for the current episode of the disease; concomitant diseases)

        -  body temperature (morning/evening)

        -  chills and fever (cumulative score based on all symptoms: 0-no symptoms, 1-mild,
           2-moderate, 3-severe)

        -  intoxication symptom (cumulative score based on all symptoms: 0-no symptoms, 1-mild,
           2-moderate, 3-severe)

        -  catarrhal symptoms (cumulative score based on all symptoms: 0 - no symptoms, 1-mild,
           2-moderate, 3-severe)

        -  timelines: the beginning of the disease, the first visit to the doctor, the beginning of
           treatment, the duration of the disease

        -  determination the causative agent by PCR (on presentation of patients and their
           discharge on 5-6 days from start of therapy)

        -  antiviral therapy (Kagocel dose depending on age)

        -  symptomatic treatment of the current episode of influenza or ARVI before and during the
           patient's hospitalization

        -  bacterial exacerbations (Yes/no)

        -  treatment of bacterial exacerbations (drug name)

        -  adverse events
    

Intervention name(s): Kagocel
Intervention type(s): Drug
Intervention description(s): The researchers prescribed antiviral medications, including Kagocel, according to routine clinical practice. Patients who were assigned Kagocel were invited to participate in the study.
Kagocel administration:
for children from 3 to 6 years old (n=41): In the first 2 days - 1 tablet 2 times a day, in the next 2 days - 1 tablet once a day. Total for the course of administration 6 tablets within the period of 4 days.
for children from 6 years old (n=39) - administered in the first 2 days - 1 tablet 3 times a day, in the next 2 days - 1 tablet 2 times a day. Total for the course of administration 10 tablets within the period of 4 days.
Observational model: Cohort
Time perspective: Prospective
Sampling method: Non-Probability Sample
Study population: 
        patients with confirmed diagnosis of influenza or influenza-like illness caused by a
        different type of virus which are on anti-flu therapy
      
Keywords: influenza; flu; acute respiratory viral infection; ARVI; acute upper respiratory infection; AURI