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This study examined the etiology of acute respiratory viral infections (ARVI) during the 2015-2016 season, evaluated the statistics of the incidence of influenza and ARVI in this period (epidemiology: severity of the disease and bacterial exacerbations; demographics of patients; duration and timing of treatment; safety; quality of treatment), and evaluated the effectiveness of complex therapy with an emphasis on the using of interferon inducers in hospitalized children aged 3 to 11 years.
This non-interventional observational study included 80 patients aged 3 to 11 years who were hospitalized with influenza and acute respiratory viral infections (ARVI) symptoms at any time from the onset of the disease (up to 15 days) and who were prescribed the interferon inducer Kagocel as an antiviral medicine.
The diagnosis of influenza and ARVI was confirmed in accordance with the world health organization (who) guidelines for the pharmacological treatment of pandemic influenza A (H1N1) 2009 and other influenza viruses.
All patient examinations are conducted in accordance with local routine clinical practice and local and international standards of care.
After the end of treatment, the following data were collected and analyzed:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapy with interferons' inducers | Therapy according to routine practice (including Kagocel) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kagocel | Drug | The researchers prescribed antiviral medications, including Kagocel, according to routine clinical practice. Patients who were assigned Kagocel were invited to participate in the study. Kagocel administration:
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR | Identification of respiratory viruses such as influenza a and b, human respiratory syncytial virus, parainfluenza viruses of types 1-4, coronaviruses, metapneumoviruses, rhinoviruses, adenoviruses of groups B, C, E, and bokaviruses, and assessment of the duration of their isolation | 2 points: day of hospitalization and 5-6 day of treatment |
| Duration and severity of fever in patients with influenza and in patients with ARVI | up to 7 days (at least) | |
| The dynamics and the severity of intoxication and catarrhal syndromes in patients with influenza and in patients with ARVI | Intoxication syndrome: drowsiness, muscle pain, weakness, sweating, chills, eye pain, headache. Catarrhal syndromes: pharyngeal hyperemia, cough, rhinorrhea, nasal congestion, sore throa. Qualitative signs were evaluated in points-absence of a sign-0 points, weakly expressed sign - 1 point, medium (moderate) expressed-2 points, bright (strongly) expressed-3 points | up to 7 days (at least) |
| Number of participants with symptoms of ARVI or influenza | Number of patients with intoxication syndrome (drowsiness, muscle pain, weakness, sweating, chills, eye pain, headache), catarrhal syndromes (pharyngeal hyperemia, cough, rhinorrhea, nasal congestion, sore throa) and fever | up to 7 days (at least) |
| Number of participants who required antibiotic therapy | up to 7 days (at least) | |
| Number of participants with ARVI and influenza complications | up to 7 days (at least) |
| 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 7 days (at least) |
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Inclusion Criteria:
Exclusion Criteria:
- patients who received antiviral and immunomodulatory medications within 15 days prior to hospitalization
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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 |
|---|---|---|
| Irina Babachenko, Professor, Dr. habilitated | Research Institute of Children's Infections of the Federal Medical and Biological Agency, | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Institute of Children's Infections of the Federal Medical and Biological Agency, | Saint Petersburg | 197022 | Russia |
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| Label | URL |
|---|---|
| Sharipova E.V., Babachenko I.V., Levina A.S., Grigoriev S.G. Antiviral therapy of acute respiratory viral infection and influenza in children in a hospital. Journal Infectology. 2018;10(4):82-88. (In Russ.) doi.org/10.22625/2072-6732-2018-10-4-82-88 | View source |
| Babachenko I.V., Sharipova E.V., Belikova T.L. Hospital- and clinic-based approaches to the treatment of ARVI in children. Meditsinskiy sovet = Medical Council. 2017;(1):94-99. (In Russ.) https://doi.org/10.21518/2079-701X-2017-1-94-99 | View source |
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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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|
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |