Treatment of Influenza in Routine Clinical Practice

Nearmedic Plus LLC18,946 enrolled

Overview

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.

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 Type

OBSERVATIONAL

Enrollment

18,946

Conditions

Influenza Acute Upper Respiratory Infection

Interventions

KagocelDRUG

Investigators could prescribe other drugs in frame of routine clinical practice

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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

Locations (4)

Yerevan State Medical University after M. Heratsi

Yerevan, Armenia

Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University

Tbilisi, Georgia

State University of Medicine and Pharmacy Nicolae Testemitanu

Chisinau, Moldova

Kazan State Medical University

Kazan', Russia

Outcomes

Primary Outcomes

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

Time frame: 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)

Time frame: up to 14 days

The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)

Time frame: up to 14 days

Frequency of influenza complications with antibacterial drugs administration requirement

Time frame: up to 14 days

Secondary Outcomes

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)

Time frame: up to 14 days

Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient)

Time frame: up to 14 days

Data from ClinicalTrials.gov

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