Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 18,946
- 试验地点
- 4
- 主要终点
- The socio-demographic data and symptoms of disease in the joint population of patients with influenza and influenza-like illness caused by different types of viruses
研究概览
简要总结
This study evaluates the statistics of influenza and acute respiratory viral infections (ARVI) management in outpatient sites in Russia, Armenia, Moldova and Georgia (epidemiology: disease severity and bacterial exacerbations; patients demography; treatment duration and timelines; safety; quality of treatment) in routine clinical practice with focus on drug therapy and usage of interferons' inducers.
详细描述
This non-interventional study covers more than 15000 patients from outpatient sites in Russia, Armenia, Moldova and Georgia.
Influenza and acute respiratory viral infections (ARVI) diagnosis validate according to "World Health Organization (WHO) Guidelines for Pharmacological Management of Pandemic Influenza A (H1N1) 2009 and other Influenza Viruses". All patients' examinations are carried out according to the local routine clinical practice and local and international standards of care.
The following data will be collected and analyzed after the end of treatment:
- demography
- disease severity
- body temperature
- chills and fever (no/mild/severe)
- weakness (no/mild/severe)
- muscle or joint pain (no/mild/severe)
- rhinitis (yes/no)
- throat irritation (no/mild/severe)
- headache (no/mild/severe)
- cough (no/mild/severe)
- conjunctivitis (no/mild/severe)
- timelines: disease onset, first visit to physician, start of treatment
- therapy (drug name, dose, with focus on interferons' inducers)
- bacterial exacerbations (yes/no)
- therapy of bacterial exacerbations (drug name)
- adverse events
- results of treatment satisfaction questionnaire for medication (TSQM-9), if completed by patient
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
- 18 Years 至 100 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients ≥ 18 years old,
- •patients diagnosed with influenza or influenza-like illness caused by a different type of virus,
- •patients to whom anti-flu treatment administered,
- •patients who have signed informed consent for management of their personal data.
排除标准
- •no exclusion criteria except participating in a current clinical trial because of non-interventional sudy design
研究组 & 干预措施
Therapy with interferons' inducers
Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis
干预措施: Kagocel (Drug)
结局指标
主要结局
The socio-demographic data and symptoms of disease in the joint population of patients with influenza and influenza-like illness caused by different types of viruses
时间窗: up to 14 days
socio-demographic data, symptoms of disease
The treatment description: names of drugs, dose, time of administration with regards to disease onset ("early" - from 1 to 3 days of symptoms; "late" - 4 or more days of symptoms)
时间窗: up to 14 days
The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)
时间窗: up to 14 days
Frequency of influenza complications with antibacterial drugs administration requirement
时间窗: up to 14 days
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 14 days)
- Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient)(up to 14 days)