InfluenzaFLU-EENCT02983019
Treatment of Influenza in Routine Clinical Practice
An observational study of Influenza and Acute Upper Respiratory Infection, run by Nearmedic Plus LLC at 4 sites in 4 countries.
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… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Influenza, Acute Upper Respiratory Infection
- What is being tested?
- Kagocel
- How many people
- 18,946 participants
- Where
- 4 sitesin 4 countries
- Study dates
- Dec 2013to Sep 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients with confirmed diagnosis of influenza or influenza-like illness caused by a different type of virus which are on anti-flu therapy
Who may be able to join
- 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.
Who cannot join
- no exclusion criteria except participating in a current clinical trial because of non-interventional sudy design
Trial locations and contacts
4 sites in 4 countries.
4 sites in 4 countries
Georgia1 site
Vl.Bakhutashvili Institute of Medical Biotechnology of Tbilisi State Medical University
Tbilisi, 01059
Moldova1 site
State University of Medicine and Pharmacy Nicolae Testemitanu
Chisinau
About this study
Official title: Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)
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.
Read the 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
- Conditions
- Influenza, Acute Upper Respiratory Infection
- Being tested
- Kagocel
- Keywords
- influenza, flu, acute respiratory viral infection, ARVI, acute upper respiratory infection, AURI
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
KagocelDrug
Investigators could prescribe other drugs in frame of routine clinical practice
| Study group | Role | What they receive |
|---|---|---|
| Therapy with interferons' inducers | Therapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis Receives: Drug: Kagocel | |
| Therapy without interferons' inducers | Therapy according to routine practice Groups will be splitted during the final data analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: up to 14 days
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)
Measured: up to 14 days
The efficacy (yes or no) of the treatment schemas with regards to severity of disease (mild, moderate, severe)
Measured: up to 14 days
Frequency of influenza complications with antibacterial drugs administration requirement
Measured: up to 14 days
Secondary outcomes (2)
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)
Measured: up to 14 days
Anti-influenza treatment schemas satisfaction rate according to TSQM-9 questionnaire (if completed by patient)
Measured: up to 14 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2016 (estimated)
- Study startDec 2013
- Primary completionDec 2015
- Study completionSep 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 18,946 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nearmedic Plus LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ivan Sitnikov, Professor, Principal investigator, Yaroslavl State Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02983019
- Sponsor's protocol ID
- ISIM-LCR
- Acronym
- FLU-EE
- Status last verified
- Feb 2017
- First submitted
- 24 Nov 2016
- Last updated
- 17 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Fazylov VK, Sitnikov IG, Silina EV, Shevchenko SB, Mozhina LN, Zamyatina LL, Yeganyan GA, Groppa LG, Korsantia BM. [Treatment for acute respiratory viral infection and influenza in daily clinical practice: Results of the multicenter international observational FLU-EE study]. Ter Arkh. 2016;88(11):68-75. doi: 10.17116/terarkh2016881168-75. Russian.
PubMed 28005034
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-interventional Study: Treatment of Influenza in Routine Clinical Practice (FLU-EE)
- ClinicalTrials.gov ID
- NCT02983019
- Acronym / sponsor ID
- FLU-EE / ISIM-LCR
- Conditions
- Influenza, Acute Upper Respiratory Infection
- Keywords
- influenza, flu, acute respiratory viral infection, ARVI, acute upper respiratory infection, AURI
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18,946 participants (actual)
- Lead sponsor
- Nearmedic Plus LLCIndustry (pharma, biotech, devices)
- Study start
- Dec 2013
- Primary completion
- Dec 2015 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 6 Dec 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Therapy with interferons' inducers | – | Drug: KagocelTherapy according to routine practice (including Kagocel) Groups will be splitted during the final data analysis |
| Therapy without interferons' inducers | – | –Therapy according to routine practice Groups will be splitted during the final data analysis |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients with confirmed diagnosis of influenza or influenza-like illness caused by a different type of virus which are on anti-flu therapy
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (1 listed)
- no exclusion criteria except participating in a current clinical trial because of non-interventional sudy design
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| KagocelInvestigators could prescribe other drugs in frame of routine clinical practice | Drug | Therapy with interferons' inducers |
Primary outcome
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
2 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)
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2017.
- Results publication: PubMed 28005034Fazylov VK, Sitnikov IG, Silina EV, Shevchenko SB, Mozhina LN, Zamyatina LL, Yeganyan GA, Groppa LG, Korsantia BM. [Treatment for acute respiratory viral infection and influenza in daily clinical practice: Results of the multicenter international observational FLU-EE study]. Ter Arkh. 2016;88(11):68-75. doi: 10.17116/terarkh2016881168-75. Russian.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ivan Sitnikov, Professor principal investigator
Yaroslavl State Medical University
4 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Influenza and Acute Upper Respiratory Infection, run by Nearmedic Plus LLC at 4 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Armenia, Georgia, Moldova, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02983019, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2017.