NCT02983019

Brief 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.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18,946

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2013

Typical duration for all trials

Geographic Reach
4 countries

4 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2015

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 24, 2016

Completed
12 days until next milestone

First Posted

Study publicly available on registry

December 6, 2016

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

2 years

First QC Date

November 24, 2016

Last Update Submit

February 16, 2017

Conditions

InfluenzaAcute Upper Respiratory Infection

Keywords

influenzafluacute respiratory viral infectionARVIacute upper respiratory infectionAURI

Outcome Measures

Primary Outcomes (4)

  • 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 Outcomes (2)

  • 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

Study Arms (2)

Therapy with interferons' inducers

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

Drug: Kagocel

Therapy without interferons' inducers

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

Interventions

KagocelDRUG

Investigators could prescribe other drugs in frame of routine clinical practice

Therapy with interferons' inducers

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Yerevan State Medical University after M. Heratsi

Yerevan, 0025, Armenia

Location

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

Tbilisi, 01059, Georgia

Location

State University of Medicine and Pharmacy Nicolae Testemitanu

Chisinau, Moldova

Location

Kazan State Medical University

Kazan', 420012, Russia

Location

Related Publications (1)

  • 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.

    PMID: 28005034RESULT

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Study Officials

  • Ivan Sitnikov, Professor

    Yaroslavl State Medical University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 24, 2016

First Posted

December 6, 2016

Study Start

December 1, 2013

Primary Completion

December 1, 2015

Study Completion

September 1, 2016

Last Updated

February 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

RU(1)MO(1)GE(1)AR(1)