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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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01683630
Enrollment
1849
Registered
2012-09-12
Start date
2012-04-30
Completion date
2012-09-30
Last updated
2016-10-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza

Keywords

Influenza, Influenza type A, Influenza type B, hospitalization, Manitoba, Canada

Brief 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.

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.

Interventions

None listed

Sponsors

International Centre for Infectious Diseases, Canada
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
6 Months to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frame
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 ManitobaUpto 15 years
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 Manitobaup 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 Manitobaupto 15 years

Countries

Canada

Participant flow

Participants by arm

ArmCount
Confirmed Cases of Influenza A
Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy
1,404
Confirmed Cases of Influenza B
Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
445
Total1,849

Baseline characteristics

CharacteristicConfirmed Cases of Influenza AConfirmed Cases of Influenza BTotal
Age, Categorical
<=18 years
511 Participants236 Participants747 Participants
Age, Categorical
>=65 years
568 Participants80 Participants648 Participants
Age, Categorical
Between 18 and 65 years
325 Participants129 Participants454 Participants
Region of Enrollment
Canada
1404 participants445 participants1849 participants
Sex: Female, Male
Female
758 Participants245 Participants1003 Participants
Sex: Female, Male
Male
646 Participants200 Participants846 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 0

Outcome results

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

Time frame: up to 15 years

ArmMeasureValue (NUMBER)
Confirmed Cases of Influenza AAge 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 Manitoba23.5 Percentage of participants
Confirmed Cases of Influenza BAge 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 Manitoba22.1 Percentage of participants
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

Time frame: upto 15 years

ArmMeasureValue (NUMBER)
Confirmed Cases of Influenza APercentage 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 Manitoba9.0 Percentage of participants
Confirmed Cases of Influenza BPercentage 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 Manitoba7.0 Percentage of participants
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

Time frame: Upto 15 years

ArmMeasureValue (NUMBER)
Confirmed Cases of Influenza ARisk 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 Manitoba4.5 percentage of participants
Confirmed Cases of Influenza BRisk 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 Manitoba2.0 percentage of participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026