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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ARVI and influenza prophylaxis with Kagocel | Prophylaxis according to routine practice and instructions for medical use of Kagocel. Group of patients receiving Kagocel for prevention of ARVI and influenza |
| |
| ARVI and influenza prophylaxis without any antiviral medicines | Group of patients receiving no any antiviral medicines for prevention of ARVI and influenza |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Kagocel | Drug | Investigators could prescribe other drugs in frame of routine clinical practice |
|
| Measure | Description | Time Frame |
|---|---|---|
| Total number of participants with ARVI or influenza | 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. | 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 | 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 | 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with ARVI or influenza | for the 1st month of taking Kagocel | |
| Number of participants with ARVI or influenza | for 1 month of follow-up after the end of the course of prevention (2-nd month of study) |
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Inclusion Criteria:
Exclusion Criteria:
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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 than 30 days prior to inclusion in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Vladimir Petrov, Dr. habilitated, Professor | Department of infectious diseases of Obninsk institute for nuclear power engineering (OINPE) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Obninsk institute for nuclear power engineering (OINPE) | Obninsk | Kaluga Oblast | 249040 | Russia |
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| Label | URL |
|---|---|
| Currently, great attention is paid to prevention of influenza and acute respiratory viral infections (ARVI). This article considers results of prospective observational study in prevention of influenza and ARVI among physicians \[Publication on russian\] | View source |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| D003139 | Common Cold |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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| No one | Drug | Investigators don't prescribe any antiviral drugs in frame of routine clinical practice |
|
| 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. | for the 1st month of taking Kagocel |
| 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. | 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) | 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 | 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 | 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 | 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) | 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) |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
| D010850 | Picornaviridae Infections |