Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting

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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
International Centre for Infectious Diseases, Canada
ClinicalTrials.gov Identifier:
NCT01683630
First received: August 31, 2012
Last updated: September 25, 2015
Last verified: September 2015
  Purpose
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.

Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of the Epidemiology and Clinical Outcomes of Laboratory-Confirmed Influenza A and Influenza B Cases in Manitoba, Canada

Resource links provided by NLM:


Further study details as provided by International Centre for Infectious Diseases, Canada:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 1849
Study Start Date: April 2012
Study Completion Date: September 2012
Primary Completion Date: September 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts
Confirmed influenza A and B cases
Cases of influenza A and B as diagnosed by PCR, viral culture or florescence microscopy

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.

  Eligibility

Ages Eligible for Study:   6 Months and older   (Child, Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Any person who normally resides in Manitoba and who has been continuously covered during the study period will be eligible for inclusion in the study.
Criteria

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:

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01683630

Locations
Canada, Manitoba
International Centre for Infectious Diseases
Winnipeg, Manitoba, Canada, R3B 3P5
Sponsors and Collaborators
International Centre for Infectious Diseases, Canada
Investigators
Principal Investigator: Salah Mahmud, MD, PhD Associate Professor, University of Manitoba
  More Information

Publications:
Responsible Party: International Centre for Infectious Diseases, Canada
ClinicalTrials.gov Identifier: NCT01683630     History of Changes
Other Study ID Numbers: ICID-2012-FLU-A,B-02 
Study First Received: August 31, 2012
Results First Received: June 30, 2015
Last Updated: September 25, 2015
Health Authority: Canada: Ethics Review Committee

Keywords provided by International Centre for Infectious Diseases, Canada:
Influenza
Influenza type A
Influenza type B
hospitalization
Manitoba
Canada

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 27, 2016