Treatment of Influenza and ARVI in Children by Kagocel ®

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04651491
• Other study ID #: version 2.0 from 10.02.2015
• Status: Completed
• Start date: September 11, 2015
• Est. completion date: September 28, 2016

Study information

• Verified date: September 2016
• Source: Nearmedic Plus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: September 28, 2016
• Est. primary completion date: May 5, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 11 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Upper Respiratory Infection
• Infection
• Influenza
• Influenza, Human
• Respiratory Tract Infections

Intervention

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: 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.

Locations

Country	Name	City	State
Russian Federation	Research Institute of Children's Infections of the Federal Medical and Biological Agency,	Saint-Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
Nearmedic Plus LLC

Country where clinical trial is conducted

Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Duration and severity of fever in patients with influenza and in patients with ARVI		up to 7 days (at least)
Primary	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)
Primary	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)
Primary	Number of participants who required antibiotic therapy		up to 7 days (at least)
Primary	Number of participants with ARVI and influenza complications		up to 7 days (at least)
Secondary	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)

External Links

•   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
•   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