- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01683630
Comparison of Epidemiology and Clinical Outcomes of Influenza A & B Cases in Manitoba, Canada
Comparison of the Epidemiology and Clinical Outcomes of Laboratory-Confirmed Influenza A and Influenza B Cases in Manitoba, Canada
Study Overview
Status
Conditions
Detailed Description
Annual epidemics of influenza are an important public health problem globally and in Canada. Each year, 10-25% of the Canadian population become infected with influenza. Most of these infections are typically asymptomatic or associated with a mild self-limiting illness. However, influenza can cause severe illness leading to hospitalization and death, especially among the very young, the elderly and among those with underlying chronic conditions. It has been estimated that on average about 4,000 influenza-related deaths occur in Canada each year. In addition, the economic burden of influenza is significant because of the high direct costs associated with increased utilization of services and the indirect costs caused by school and work absenteeism.
This project compares laboratory-confirmed cases of influenza A and B in terms of their epidemiology, and the overall and cause-specific incidence rates of important clinical outcomes including physician visits, hospitalization and death following clinical diagnosis of influenza cases in Manitoba over the period from 1993 to 2008.
The study assesses secular and seasonal trends in the incidence rates of influenza A and B cases in Manitoba during the period of 1993-2008, to determine whether these rates vary for different subsets of the population defined by demographic (e.g., age group, gender), socioeconomic, geographic (neighborhood of residence) and clinical (e.g., vaccination, presence of chronic conditions, immune status) characteristics.
The analysis by influenza type then compares the overall and cause-specific incidence rates of physician visits, hospitalization and death following the diagnosis of a laboratory-confirmed influenza. The effects of influenza type on clinical outcomes (e.g., hospitalization) are assessed with multivariate models while accounting for potential confounding by demographic, socioeconomic, geographic and clinical (e.g., co-morbidity, immune status) characteristics.
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Manitoba
-
Winnipeg, Manitoba, Canada, R3B 3P5
- International Centre for Infectious Diseases
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Any person who normally resides in Manitoba and who has been continuously covered by Manitoba Health during the study period will be eligible for inclusion in the study.
Exclusion Criteria:
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Confirmed influenza A and B cases
Cases of influenza A and B as diagnosed by PCR, viral culture or florescence microscopy
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Age Adjusted Percentage of Participants With a Physician Visit Due to Any Diagnosis Within 30 Days of the Index Date of the Confirmed Influenza A and B Cases in the Province of Manitoba
Time Frame: up to 15 years
|
up to 15 years
|
Percentage of Participants With a Risk of Hospitalization Due to Any Diagnosis Within 30 Days Following the Index Date of Confirmed Cases of Influenza A and B in the Province of Manitoba
Time Frame: upto 15 years
|
upto 15 years
|
Risk of Death Due to Any Cause During 30 Days Following the Index Date of Laboratory Confirmed Cases of Influenza A and B in the Province of Manitoba
Time Frame: Upto 15 years
|
Upto 15 years
|
Collaborators and Investigators
Investigators
- Principal Investigator: Salah Mahmud, MD, PhD, Associate Professor, University of Manitoba
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ICID-2012-FLU-A,B-02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Influenza
-
Novartis VaccinesCompletedInfluenza | Seasonal Influenza | Human Influenza | Influenza Due to Unspecified Influenza VirusBelgium
-
Gamaleya Research Institute of Epidemiology and...CompletedInfluenza A | Influenza A Virus Infection | Influenza Epidemic | Influenza H5N1Russian Federation
-
Vanderbilt University Medical CenterHuman Vaccines ProjectCompletedVaccine Reaction | Influenza | Influenza, Human | Influenza A | Influenza Type B | Influenza A H3N2 | Influenza A H1N1United States
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...Completed
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Influenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza Immunisation | Avian InfluenzaUnited States
-
National Institute of Allergy and Infectious Diseases...National Institutes of Health (NIH)CompletedInfluenza AUnited States
-
National Institute of Allergy and Infectious Diseases...CompletedInfluenza | Avian Influenza | H1N1 InfluenzaUnited States