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Clinical Trial Summary

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.


Clinical Trial Description

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 ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02983019
Study type Observational
Source Nearmedic Plus LLC
Contact
Status Completed
Phase N/A
Start date December 2013
Completion date September 2016

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