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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.
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy with interferons' inducers | Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis |
| |
| Therapy without interferons' inducers | Therapy according to routine practice Groups will be splitted during the final data analysis |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kagocel | Drug | Investigators could prescribe other drugs in frame of routine clinical practice |
|
| 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 |
| Measure | Description | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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patients with confirmed diagnosis of influenza or influenza-like illness caused by a different type of virus which are on anti-flu therapy
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| Name | Affiliation | Role |
|---|---|---|
| Ivan Sitnikov, Professor | Yaroslavl State Medical University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yerevan State Medical University after M. Heratsi | Yerevan | 0025 | Armenia | |||
| Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28005034 | Result | 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. |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| up to 14 days |
| Tbilisi |
| 01059 |
| Georgia |
| State University of Medicine and Pharmacy Nicolae Testemitanu | Chisinau | Moldova |
| Kazan State Medical University | Kazan' | 420012 | Russia |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |