Treatment of Influenza in Routine Clinical Practice

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT02983019
• Date of registration: 24/11/2016
• Prospective Registration: No
• Primary sponsor: Nearmedic Plus LLC
• Public title: Treatment of Influenza in Routine Clinical Practice FLU-EE
• Scientific title: Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)
• Date of first enrolment: December 2013
• Target sample size: 18946
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02983019
• Study type: Observational
• Phase: N/A

Countries of recruitment

Armenia, Georgia, Moldova, Republic of, Russian Federation

Contacts

• Name: Ivan Sitnikov, Professor
• Affiliation: Yaroslavl State Medical University

Key inclusion & exclusion criteria

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



Age minimum: 18 Years
Age maximum: 100 Years
Gender: All

Health Condition(s) or Problem(s) studied

Influenza

Acute Upper Respiratory Infection

Intervention(s)

Drug: Kagocel

Primary Outcome(s)

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]

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]

Secondary Outcome(s)

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) [Time Frame: up to 14 days]

Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient) [Time Frame: up to 14 days]

Secondary ID(s)

ISIM-LCR

Source(s) of Monetary Support

Please refer to primary and secondary sponsors