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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02983019
Recruitment Status : Completed
First Posted : December 6, 2016
Last Update Posted : February 17, 2017
Sponsor:
Information provided by (Responsible Party):
Nearmedic Plus LLC

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.

Condition or disease Intervention/treatment
Influenza Acute Upper Respiratory Infection 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

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Study Type : Observational
Actual Enrollment : 18946 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)
Study Start Date : December 2013
Actual Primary Completion Date : December 2015
Actual Study Completion Date : September 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot

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



Primary Outcome Measures :
  1. 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 [ Time Frame: up to 14 days ]
    socio-demographic data, symptoms of disease

  2. 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 ]
  3. The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe) [ Time Frame: up to 14 days ]
  4. Frequency of influenza complications with antibacterial drugs administration requirement [ Time Frame: up to 14 days ]

Secondary Outcome Measures :
  1. 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 ]
  2. Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient) [ Time Frame: up to 14 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02983019


Locations
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Armenia
Yerevan State Medical University after M. Heratsi
Yerevan, Armenia, 0025
Georgia
Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University
T'bilisi, Georgia, 01059
Moldova, Republic of
State University of Medicine and Pharmacy Nicolae Testemitanu
Kishinev, Moldova, Republic of
Russian Federation
Kazan State Medical University
Kazan', Russian Federation, 420012
Sponsors and Collaborators
Nearmedic Plus LLC
Investigators
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Principal Investigator: Ivan Sitnikov, Professor Yaroslavl State Medical University

Publications of Results:
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Responsible Party: Nearmedic Plus LLC
ClinicalTrials.gov Identifier: NCT02983019     History of Changes
Other Study ID Numbers: ISIM-LCR
First Posted: December 6, 2016    Key Record Dates
Last Update Posted: February 17, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Nearmedic Plus LLC:
influenza
flu
acute respiratory viral infection
ARVI
acute upper respiratory infection
AURI

Additional relevant MeSH terms:
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Infection
Influenza, Human
Respiratory Tract Infections
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Diseases
Interferons
Interferon Inducers
Antineoplastic Agents
Antiviral Agents
Anti-Infective Agents
Immunologic Factors
Physiological Effects of Drugs