NCT02983019

Treatment of Influenza in Routine Clinical Practice

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 18,946 (actual)
• Sponsor: Nearmedic Plus LLC · Industry
• Sex: All
• Age: 18 Years – 100 Years
• Healthy volunteers: Not accepted

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.

Detailed 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

Conditions

• Influenza
• Acute Upper Respiratory Infection

Interventions

Type	Name	Description
DRUG	Kagocel	Investigators could prescribe other drugs in frame of routine clinical practice

Timeline

• Start date: 2013-12-01
• Primary completion: 2015-12-01
• Completion: 2016-09-01
• First posted: 2016-12-06
• Last updated: 2017-02-17

Locations

4 sites across 4 countries: Armenia, Georgia, Moldova, Russia