NCT04651491

Treatment of Influenza and ARVI in Children by Kagocel ®

Study of Antiviral Therapy of Influenza and ARVI With Kagocel ® in Children

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 80 (actual)
• Sponsor: Nearmedic Plus LLC · Industry
• Sex: All
• Age: 3 Years – 11 Years
• Healthy volunteers: Not accepted

Summary

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.

Detailed description

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: * demography * disease severity * anamnesis data (data of influenza vaccination in the current season; pre-school facilities visits; previous contacts with a patient with influenza / ARVI; previous antiviral therapy for the current episode of the disease; concomitant diseases) * body temperature (morning/evening) * chills and fever (cumulative score based on all symptoms: 0-no symptoms, 1-mild, 2-moderate, 3-severe) * intoxication symptom (cumulative score based on all symptoms: 0-no symptoms, 1-mild, 2-moderate, 3-severe) * catarrhal symptoms (cumulative score based on all symptoms: 0 - no symptoms, 1-mild, 2-moderate, 3-severe) * timelines: the beginning of the disease, the first visit to the doctor, the beginning of treatment, the duration of the disease * determination the causative agent by PCR (on presentation of patients and their discharge on 5-6 days from start of therapy) * antiviral therapy (Kagocel dose depending on age) * symptomatic treatment of the current episode of influenza or ARVI before and during the patient's hospitalization * bacterial exacerbations (Yes/no) * treatment of bacterial exacerbations (drug name) * adverse events

Conditions

• Influenza
• Acute Upper Respiratory Infection

Interventions

Type	Name	Description
DRUG	Kagocel	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: 1. for children from 3 to 6 years old (n=41): In the first 2 days - 1 tablet 2 times a day, in the next 2 days - 1 tablet once a day. Total for the course of administration 6 tablets within the period of 4 days. 2. for children from 6 years old (n=39) - administered in the first 2 days - 1 tablet 3 times a day, in the next 2 days - 1 tablet 2 times a day. Total for the course of administration 10 tablets within the period of 4 days.

Timeline

• Start date: 2015-09-11
• Primary completion: 2016-05-05
• Completion: 2016-09-28
• First posted: 2020-12-03
• Last updated: 2020-12-03

Locations

1 site across 1 country: Russia