Treatment of Influenza in Routine Clinical Practice

Study Overview
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Brief Summary
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This study evaluates the statistics of influenza and acute respiratory viral infections (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology: disease severity and bacterial exacerbations; patients demography; treatment duration and timelines; safety; quality of treatment) in routine clinical practice with focus on drug therapy and usage of interferons' inducers.

Detailed Description
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This non-interventional study covers more than 15000 patients from outpatient sites in Russia, Armenia, Moldova and Georgia. Influenza and acute respiratory viral infections (ARVI) diagnosis validate according to World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) 2009 and other Influenza Viruses. All patients' examinations are carried out according to the local routine clinical practice and local and international standards of care. The following data will be collected and analyzed after the end of treatment: demography disease severity body temperature chills and fever (no/mild/severe) weakness (no/mild/severe) muscle or joint pain (no/mild/severe) rhinitis (yes/no) throat irritation (no/mild/severe) headache (no/mild/severe) cough (no/mild/severe) conjunctivitis (no/mild/severe) timelines: disease onset, first visit to physician, start of treatment therapy (drug name, dose, with focus on interferons' inducers) bacterial exacerbations (yes/no) therapy of bacterial exacerbations (drug name) adverse events results of treatment satisfaction questionnaire for medication (TSQM-9), if completed by patient

Official Title
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Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)

Conditions
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Influenza, Acute Upper Respiratory Infection

Intervention / Treatment
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* Drug: Kagocel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: patients ≥ 18 years old, patients diagnosed with influenza or influenza-like illness caused by a different type of virus, patients to whom anti-flu treatment administered, patients who have signed informed consent for management of their personal data. Exclusion Criteria: no exclusion criteria except participating in a current clinical trial because of non-interventional sudy design

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Therapy with interferons' inducers<br>Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis | Drug: Kagocel<br>* Investigators could prescribe other drugs in frame of routine clinical practice<br>|
| Therapy without interferons' inducers<br>Therapy according to routine practice Groups will be splitted during the final data analysis | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The socio-demographic data and symptoms of disease in the joint population of patients with influenza and influenza-like illness caused by different types of viruses | socio-demographic data, symptoms of disease | up to 14 days | 
| The treatment description: names of drugs, dose, time of administration with regards to disease onset (early - from 1 to 3 days of symptoms; late - 4 or more days of symptoms) |  | up to 14 days | 
| The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe) |  | up to 14 days | 
| Frequency of influenza complications with antibacterial drugs administration requirement |  | up to 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events (AE) with regards to type and severity of AE (mild, moderate, severe; according to physician's opinion) |  | up to 14 days | 
| Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient) |  | up to 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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influenza, flu, acute respiratory viral infection, ARVI, acute upper respiratory infection, AURI