Treatment of Influenza in Routine Clinical Practice
- Registration Number
- NCT02983019
- Lead Sponsor
- Nearmedic Plus LLC
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 18946
- 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.
- no exclusion criteria except participating in a current clinical trial because of non-interventional sudy design
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Therapy with interferons' inducers Kagocel Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (4)
Yerevan State Medical University after M. Heratsi
🇦🇲Yerevan, Armenia
State University of Medicine and Pharmacy Nicolae Testemitanu
🇲🇩Kishinev, Moldova, Republic of
Kazan State Medical University
🇷🇺Kazan', Russian Federation
Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University
🇬🇪T'bilisi, Georgia