Study of Antiviral Therapy of Influenza and ARVI With Kagocel ® in Children
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- Number of participants with symptoms of ARVI or influenza
研究概览
简要总结
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.
详细描述
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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •patients who received antiviral and immunomodulatory medications within 15 days prior to hospitalization
研究组 & 干预措施
Therapy with interferons' inducers
Therapy according to routine practice (including Kagocel)
干预措施: Kagocel (Drug)
结局指标
主要结局
Number of participants with symptoms of ARVI or influenza
时间窗: 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
Number of participants with ARVI and influenza complications
时间窗: up to 7 days (at least)
Changes in the number of respiratory viruses in nasopharyngeal smears by multiplex PCR
时间窗: 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
Duration and severity of fever in patients with influenza and in patients with ARVI
时间窗: up to 7 days (at least)
Number of participants who required antibiotic therapy
时间窗: 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
时间窗: 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
次要结局
- 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))