Clinical trial NCT04651491: Treatment of Influenza and ARVI in Children by Kagocel ®
Official title: Study of Antiviral Therapy of Influenza and ARVI With Kagocel ® in Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Acute Upper Respiratory Infection
Keywords: influenza
flu
acute respiratory viral infection
ARVI
acute upper respiratory infection
AURI
Lead sponsor: Nearmedic Plus LLC
Sponsor class: INDUSTRY
First posted: 2020-12-03
Enrollment: 80
Sex: ALL
Minimum age (years): 3
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Detailed 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

Eligibility criteria: 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

Primary outcomes:
measure: Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR
timeFrame: 2 points: day of hospitalization and 5-6 day of treatment
measure: Duration and severity of fever in patients with influenza and in patients with ARVI
timeFrame: up to 7 days (at least)
measure: The dynamics and the severity of intoxication and catarrhal syndromes in patients with influenza and in patients with ARVI
timeFrame: up to 7 days (at least)
measure: Number of participants with symptoms of ARVI or influenza
timeFrame: up to 7 days (at least)
measure: Number of participants who required antibiotic therapy
timeFrame: up to 7 days (at least)
measure: Number of participants with ARVI and influenza complications
timeFrame: up to 7 days (at least)
Secondary outcomes:
measure: 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)
timeFrame: up to 7 days (at least)
Other outcomes:
Locations:
city: Saint-Petersburg
country: Russian Federation
facility: Research Institute of Children's Infections of the Federal Medical and Biological Agency,
Study officials:
affiliation: Research Institute of Children's Infections of the Federal Medical and Biological Agency,
name: Irina Babachenko, Professor, Dr. habilitated
role: PRINCIPAL_INVESTIGATOR
References: