Treatment of Influenza and ARVI in Children by Kagocel ®

NCT04651491 | Completed

• 1 other identifier: version 2.0 from 10.02.2015
• Study Type: observational
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Influenza; Acute Upper Respiratory Infection

Keywords

influenza; flu; acute respiratory viral infection; ARVI; acute upper respiratory infection; AURI

Outcome Measures

Primary Outcomes (6)

• 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)

Secondary Outcomes (1)

• 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)

Study Arms (1)

Therapy with interferons' inducers

Therapy according to routine practice (including Kagocel)

Drug: Kagocel

Interventions

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: 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.

Therapy with interferons' inducers

Eligibility Criteria

• Age: 3 Years - 11 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• 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

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Nearmedic Plus LLC: lead

Study Sites (1)

Research Institute of Children's Infections of the Federal Medical and Biological Agency,

Saint Petersburg, 197022, Russia

Location

Related Links

• 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
• 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

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Study Officials

• Irina Babachenko, Professor, Dr. habilitated

  Research Institute of Children's Infections of the Federal Medical and Biological Agency,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 3, 2020
• Study Start: September 11, 2015
• Primary Completion: May 5, 2016
• Study Completion: September 28, 2016
• Last Updated: December 3, 2020

Record last verified: 2016-09

Data Sharing

• IPD Sharing: Will not share

Locations

RU (1)