Study on Safety and Effectiveness of Ergoferon in the Treatment of Flu / ARVI in Outpatients.
Condition: Viral Respiratory Infection
MeSH terms: Infections; Respiratory Tract Infections
Study type: Observational

Summary: 
      The observational study to get the additional data of the safety and effectiveness of
      Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients.
    

Detailed description: 
      This observational study is aimed to provide additional safety and effectiveness data for
      Ergoferon in the treatment of influenza/ARVI in adult and pediatric outpatients, including
      cases with delayed treatment initiation of illness, and in allergy patients. Routine clinical
      practice in the management of outpatients with ARVI is to be studied in Azerbaijan, Armenia,
      Georgia, Kazakhstan, Kyrgyzstan, Mongolia, Tajikistan and Uzbekistan: the demographic
      characteristics of patients, duration and time points of treatment with the use of Ergoferon,
      its safety, and the frequency of additional medication.

      Scope of the study: 519 general practitioners; 8411 patients. Physical examinations and tests
      are performed according to local outpatient clinical practice, and to local and international
      medical care standards.

      Data to be collected and analyzed after the completion of treatment:

        -  demographics (age, gender, and city/town of residence)

        -  severity of illness (mild, moderate, or severe)

        -  comorbidities (chronic ENT conditions, chronic obstructive pulmonary disease (COPD),
           chronic cardiovascular disease, allergic rhinitis/sinusitis, atopic dermatitis/eczema,
           asthma, or other)

        -  the time of resolution of infection symptoms (absence of fever - a body temperature
           below 37.0°С), systemic symptoms (chills, headaches, myalgias, weakness, and loss of
           appetite), nasal symptoms (nasal congestion/ discharge), laryngeal symptoms (a sore
           throat, or other), and other symptoms

        -  illness time points: onset of illness, first visit to the doctor's office, and start of
           treatment.

        -  symptomatic therapy (drug name, date prescribed, and date discontinued)

        -  therapy for bacterial complications (date the antimicrobial drug is prescribed, drug
           name, diagnosis, hospitalization or no hospitalization required, date of
           hospitalization)

        -  serious adverse events (description of the event, causality (related/ not related to
           Ergoferon), severity, date of the onset, and actions taken)

        -  efficacy assessment of the Ergoferon treatment (high efficacy: recovery / satisfactory:
           improvement/ insufficient: no effect) - observational study model: cohort Cohort study
           is an observation of outcomes in a group of individuals linked by shared characteristics
           (an acute respiratory viral infections and use of Ergoferon).
    

Intervention name(s): Ergoferon
Intervention type(s): Drug
Intervention description(s): Oral administration
Observational model: Cohort
Time perspective: Retrospective
Sampling method: Non-Probability Sample
Study population: 
        Children from 6 months to 18 years of age and adults over 18 years of age in any gender and
        demographic proportion.