this study evaluates the use of Kagocel for the prevention of acute respiratory viral infections (ARVI) and influenza during the epidemic rise in morbidity in Russia in the 2017-2018 season (epidemiology: number of cases during the period of taking Kagocel and follow-up, severity of the disease, bacterial exacerbations, number of repeated episodes (reinfection); patients demography; safety) in health care workers who are at risk.
This non-interventional prospective study included 204 health care workers over the age of 18 who had no symptoms of acute respiratory viral infections (ARVI) and influenza at the time of inclusion and had not taken any antiviral medications to prevent ARVI and influenza for 30 days before. The total duration of the study was 2 months: the first month participants took either Kagocel (the main group), or did not take anything at all (the control group), during the next 1 month all participants were monitored. The diagnosis of influenza and ARVI has been confirmed in accordance with the world health organization (WHO) guidelines for the pharmacological treatment of pandemic influenza A (H1N1) 2009 and other influenza viruses. All patient examinations are conducted in accordance with local routine clinical practice and local and international standards of care. By the study were analysed and compared those data between groups: * demography * anamnesis data (the incidence of ARVI and flu, the date of the lastest episode of the disease, the presence of concomitant diseases, including ENT-organs, the date of the lastest influenza vaccination). * timelines: start of Kagocel's prevention - only for the group receiving Kagocel's prevention, start of the disease, duration of ARVI and influenza symptoms (fever, headache, runny nose, sore throat, cough), start of treatment * need for antiviral therapy (Yes/no) * antiviral therapy (Yes/no, drug name) * bacterial exacerbations (Yes/no) * treatment of bacterial exacerbations (Yes/no) * adverse events
Study Type
OBSERVATIONAL
Enrollment
204
Obninsk institute for nuclear power engineering (OINPE)
Obninsk, Kaluga Oblast, Russia
Total number of participants with ARVI or influenza
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Index of preventive efficacy
Index of preventive efficacy or I I= P2/P1; P1 - patients (who get disease; %) in the experimental (main) group; P2 - patients (who get disease; %) in the control group.
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Total number of participants who required antiviral therapy
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Total number of participants who required antibiotic therapy
Time frame: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)
Number of participants with ARVI or influenza
Time frame: for the 1st month of taking Kagocel
Number of participants with ARVI or influenza
Time frame: for 1 month of follow-up after the end of the course of prevention (2-nd month of study)
Index of preventive efficacy (1)
Index of preventive efficacy (1) or I(1) I(1)= P2(1)/P1(1); P1(1) - patients (who get disease; %) in the experimental (main) group during the certain study period; P2(1) - patients (who get disease; %) in the control group during the certain study period.
Time frame: for the 1st month of taking Kagocel
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Index of preventive efficacy (2)
Index of preventive efficacy (2) or I(2) I(2)= P2(2)/P1(2); P1(2) - patients (who get disease; %) in the experimental (main) group during the certain study period; P2(2) - patients (who get disease; %) in the control group during the certain study period.
Time frame: 1 month after the end of the course of prevention
Number of participants who have been ill repeatedly (twice or more) ARVI or influenza (reinfection)
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
Number of vaccinated participants who have ARVI or influenza
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
Number of vaccinated participants who required antiviral therapy
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
Number of vaccinated participants who required antibiotic therapy
Time frame: 3 points: 1. for the 1st month of taking Kagocel 2. for 1 month of follow-up after the end taking Kagocel (2-nd month of study) 3. full period of study (1 point+2 point)
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: for the entire study period (for 2 months: for the 1st month of taking Kagocel+ for 1 month of follow-up after the end of the course of prevention)