Clinical trial NCT02983019: Treatment of Influenza in Routine Clinical Practice
Official title: Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Acute Upper Respiratory Infection
Keywords: influenza
flu
acute respiratory viral infection
ARVI
acute upper respiratory infection
AURI
Lead sponsor: Nearmedic Plus LLC
Sponsor class: INDUSTRY
First posted: 2016-12-06
Enrollment: 18946
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

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

Eligibility 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

Primary outcomes:
measure: 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
timeFrame: up to 14 days
measure: 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)
timeFrame: up to 14 days
measure: The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)
timeFrame: up to 14 days
measure: Frequency of influenza complications with antibacterial drugs administration requirement
timeFrame: up to 14 days
Secondary outcomes:
measure: 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)
timeFrame: up to 14 days
measure: Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient)
timeFrame: up to 14 days
Other outcomes:
Locations:
city: Yerevan
country: Armenia
facility: Yerevan State Medical University after M. Heratsi
city: T'bilisi
country: Georgia
facility: Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University
city: Kishinev
country: Moldova, Republic of
facility: State University of Medicine and Pharmacy Nicolae Testemitanu
city: Kazan'
country: Russian Federation
facility: Kazan State Medical University
Study officials:
affiliation: Yaroslavl State Medical University
name: Ivan Sitnikov, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.