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NCT Number: NCT02983019

Treatment of Influenza in Routine Clinical Practice

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.

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Key information

Conditions

Influenza Acute Upper Respiratory Infection Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Yerevan State Medical University after M. Heratsi, Yerevan, Armenia

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About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Kagocel

Drug

Investigators could prescribe other drugs in frame of routine clinical practice

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Nearmedic Plus LLC

Industry

Registry information

Official study title

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

Acronym: FLU-EE

Important dates

Study start
2013
Primary completion
2015
Study completion
2016
First posted
Dec 6, 2016
Registry last updated
Feb 17, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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