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

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

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.

Study Overview

• Status: Completed
• Conditions: Influenza; Acute Upper Respiratory Infection
• Intervention / Treatment: Drug: Kagocel

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

• Study Type: Observational
• Enrollment (Actual): 18946

Contacts and Locations

Study Locations

• Armenia
  • Yerevan, Armenia, 0025
    • Yerevan State Medical University after M. Heratsi
• Georgia
  • T'bilisi, Georgia, 01059
    • Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University
• Moldova, Republic of
  • Kishinev, Moldova, Republic of
    • State University of Medicine and Pharmacy Nicolae Testemitanu
• Russian Federation
  • Kazan', Russian Federation, 420012
    • Kazan State Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 100 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients with confirmed diagnosis of influenza or influenza-like illness caused by a different type of virus which are on anti-flu therapy

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Therapy with interferons' inducers; Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis	Drug: Kagocel; Investigators could prescribe other drugs in frame of routine clinical practice
Therapy without interferons' inducers; Therapy according to routine practice Groups will be splitted during the final data analysis

What is the study measuring?

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	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

Collaborators and Investigators

• Sponsor: Nearmedic Plus LLC
• Investigators: Principal Investigator: Ivan Sitnikov, Professor, Yaroslavl State Medical University

Publications and helpful links

General Publications

• Fazylov VK, Sitnikov IG, Silina EV, Shevchenko SB, Mozhina LN, Zamyatina LL, Yeganyan GA, Groppa LG, Korsantia BM. [Treatment for acute respiratory viral infection and influenza in daily clinical practice: Results of the multicenter international observational FLU-EE study]. Ter Arkh. 2016;88(11):68-75. doi: 10.17116/terarkh2016881168-75. Russian.

Study record dates

Study Major Dates

• Study Start: December 1, 2013
• Primary Completion (ACTUAL): December 1, 2015
• Study Completion (ACTUAL): September 1, 2016

Study Registration Dates

• First Submitted: November 24, 2016
• First Submitted That Met QC Criteria: December 1, 2016
• First Posted (ESTIMATE): December 6, 2016

Study Record Updates

• Last Update Posted (ACTUAL): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: influenza; flu; acute respiratory viral infection; ARVI; acute upper respiratory infection; AURI
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Infections; Influenza, Human; Respiratory Tract Infections
• Other Study ID Numbers: ISIM-LCR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO