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Completed

NCT Number: NCT04651491

Treatment of Influenza and ARVI in Children by Kagocel ®

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.

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Key information

Conditions

Influenza Acute Upper Respiratory Infection Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

3 year–11 year

Sex eligibility

All sexes

Study type

Observational

Primary location

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

Saint Petersburg, 197022, Russia

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

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

Treatment and study plan

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:

  • 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.
  • 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.

Primary outcomes

  1. Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR

    Time frame: 2 points: day of hospitalization and 5-6 day of treatment

    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. Duration and severity of fever in patients with influenza and in patients with ARVI

    Time frame: up to 7 days (at least)

  3. The dynamics and the severity of intoxication and catarrhal syndromes in patients with influenza and in patients with ARVI

    Time frame: up to 7 days (at least)

    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

  4. Number of participants with symptoms of ARVI or influenza

    Time frame: up to 7 days (at least)

    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

  5. Number of participants who required antibiotic therapy

    Time frame: up to 7 days (at least)

  6. Number of participants with ARVI and influenza complications

    Time frame: 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)

    Time frame: up to 7 days (at least)

Sponsors and collaborators

Lead sponsor

Nearmedic Plus LLC

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 3, 2020
Registry last updated
Dec 3, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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