Acute Upper Respiratory Infection, Influenza
Conditions
Keywords
influenza, flu, acute respiratory viral infection, ARVI, acute upper respiratory infection, AURI
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
Interventions
DRUGKagocel
Investigators could prescribe other drugs in frame of routine clinical practice
Sponsors
Nearmedic Plus LLC
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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) | up to 14 days | — |
| The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe) | up to 14 days | — |
| Frequency of influenza complications with antibacterial drugs administration requirement | up to 14 days | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Armenia, Georgia, Moldova, Russia
Outcome results
None listed