Comparison of Epidemiology and Clinical Outcomes of Influenza A & B Cases in Manitoba, Canada

Influenza Clinical Trial

Official title:

Comparison of the Epidemiology and Clinical Outcomes of Laboratory-Confirmed Influenza A and Influenza B Cases in Manitoba, Canada

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01683630
• Other study ID #: ICID-2012-FLU-A,B-02
• Status: Completed
• Phase: N/A
• First received: August 31, 2012
• Last updated: September 25, 2015
• Start date: April 2012
• Est. completion date: September 2012

Study information

• Verified date: September 2015
• Source: International Centre for Infectious Diseases, Canada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Observational

Clinical Trial Summary

This study compares the epidemiology and clinical outcomes of laboratory confirmed influenza type A to type B following clinical diagnosis of influenza. Multivariate models are used to assess the effects of influenza type on clinical outcomes while accounting for potential confounders.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1849
• Est. completion date: September 2012
• Est. primary completion date: September 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
Canada	International Centre for Infectious Diseases	Winnipeg	Manitoba

Sponsors (1)

Lead Sponsor	Collaborator
International Centre for Infectious Diseases, Canada

Country where clinical trial is conducted

Canada, 

References & Publications (1)

Hinds AM, Bozat-Emre S, Van Caeseele P, Mahmud SM. Comparison of the epidemiology of laboratory-confirmed influenza A and influenza B cases in Manitoba, Canada. BMC Public Health. 2015 Jan 30;15:35. doi: 10.1186/s12889-015-1351-z. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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		up to 15 years	No
Primary	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		upto 15 years	No
Primary	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		Upto 15 years	No