Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)
Overview
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Nearmedic Plus LLC
- Enrollment
- 18,946
- Locations
- 4
- Primary Endpoint
- 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
Overview
Brief Summary
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.
Detailed Description
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
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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.
Exclusion Criteria
- •no exclusion criteria except participating in a current clinical trial because of non-interventional sudy design
Arms & Interventions
Therapy with interferons' inducers
Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis
Intervention: Kagocel (Drug)
Outcomes
Primary Outcomes
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
Time Frame: 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)
Time Frame: up to 14 days
The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)
Time Frame: up to 14 days
Frequency of influenza complications with antibacterial drugs administration requirement
Time Frame: up to 14 days
Secondary Outcomes
- 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)