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Treatment of Influenza and ARVI in Children by Kagocel ®

NCT ID: NCT04651491

Last Updated: 2020-12-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

80 participants

Study Classification

OBSERVATIONAL

Study Start Date

2015-09-11

Study Completion Date

2016-09-28

Brief Summary

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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.

Detailed Description

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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

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Influenza Acute Upper Respiratory Infection

Keywords

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Therapy with interferons' inducers

Therapy according to routine practice (including Kagocel)

Kagocel

Intervention Type 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.

Interventions

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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.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

3 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Nearmedic Plus LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Irina Babachenko, Professor, Dr. habilitated

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Saint Petersburg, , Russia

Site Status

Countries

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Russia

Related Links

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http://journal.niidi.ru/jofin/article/view/808

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

https://med-sovet.pro/jour/article/view/1684

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

Other Identifiers

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version 2.0 from 10.02.2015

Identifier Type: -

Identifier Source: org_study_id