Treatment of Influenza in Routine Clinical Practice (FLU-EE)

Nearmedic

Status: Completed

Conditions: Influenza; Acute Upper Respiratory Infection

Treatments: Drug: Kagocel

Study type: Observational

Funder types: Industry

Identifiers

NCT02983019

ISIM-LCR

Details and patient eligibility

About

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.

Full 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

Enrollment: 18,946 patients

Sex: All

Ages: 18 to 100 years old

Volunteers: No Healthy Volunteers

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

Trial design

18,946 participants in 2 patient groups

Therapy with interferons' inducers

Description:

Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis

Treatment:

Drug: Kagocel

Therapy without interferons' inducers

Description:

Therapy according to routine practice Groups will be splitted during the final data analysis