Treatment of Influenza and ARVI in Children by Kagocel ®

Nearmedic

Status: Completed

Conditions: Influenza; Acute Upper Respiratory Infection

Treatments: Drug: Kagocel

Study type: Observational

Funder types: Industry

Identifiers

NCT04651491

version 2.0 from 10.02.2015

Details and patient eligibility

About

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.

Full 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

Enrollment: 80 patients

Sex: All

Ages: 3 to 11 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. The patient's age from 3 to 11 years inclusive.
2. The patient was hospitalized with symptoms of influenza and ARVI.
3. The appointment of drug Kagocel ® as an antiviral therapy of influenza or ARVI by the doctor during hospitalization
4. No history of allergy and / or hypersensitivity to the components of the drug Kagocel ® .
5. Signed informed consent to participate in the study.

Exclusion criteria

• patients who received antiviral and immunomodulatory medications within 15 days prior to hospitalization

Trial design

80 participants in 1 patient group

Therapy with interferons' inducers

Description:

Therapy according to routine practice (including Kagocel)

Treatment:

Drug: Kagocel