Treatment of Influenza in Routine Clinical Practice

Influenza Clinical Trial

— FLU-EE  

Official title:

Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02983019
• Other study ID #: ISIM-LCR
• Status: Completed
• Phase: N/A
• First received: November 24, 2016
• Last updated: February 16, 2017
• Start date: December 2013
• Est. completion date: September 2016

Study information

• Verified date: February 2017
• Source: Nearmedic Plus LLC
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 18946
• Est. completion date: September 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Upper Respiratory Infection
• Infection
• Influenza
• Influenza, Human
• Respiratory Tract Infections

Intervention

Drug:
• Kagocel
Investigators could prescribe other drugs in frame of routine clinical practice

Locations

Country	Name	City	State
Armenia	Yerevan State Medical University after M. Heratsi	Yerevan
Georgia	Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University	T'bilisi
Moldova, Republic of	State University of Medicine and Pharmacy Nicolae Testemitanu	Kishinev
Russian Federation	Kazan State Medical University	Kazan'

Sponsors (1)

Lead Sponsor	Collaborator
Nearmedic Plus LLC

Countries where clinical trial is conducted

Armenia,  Georgia,  Moldova, Republic of,  Russian Federation, 

References & Publications (1)

Fazylov VK, Sitnikov IG, Silina EV, Shevchenko SB, Mozhina LN, Zamyatina LL, Eganyan GA, Groppa LG, Korsantiya BM. [Treatment for acute respiratory viral infection and influenza in daily clinical practice: Results of the multicenter international observat — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	socio-demographic data, symptoms of disease	up to 14 days
Primary	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
Primary	The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)		up to 14 days
Primary	Frequency of influenza complications with antibacterial drugs administration requirement		up to 14 days
Secondary	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
Secondary	Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient)		up to 14 days