Trial Outcomes & Findings for Comparison of Epidemiology and Clinical Outcomes of Influenza A & B Cases in Manitoba, Canada (NCT NCT01683630)

NCT ID: NCT01683630

Last Updated: 2016-10-10

Results Overview

• Recruitment status: COMPLETED
• Target enrollment: 1849 participants
• Primary outcome timeframe: up to 15 years
• Results posted on: 2016-10-10

Participant Flow

Participant milestones

Measure	Confirmed Cases of Influenza A Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy	Confirmed Cases of Influenza B Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
Overall Study STARTED	1404	445
Overall Study COMPLETED	1404	445
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Confirmed Cases of Influenza A n=1404 Participants Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy	Confirmed Cases of Influenza B n=445 Participants Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy	Total n=1849 Participants Total of all reporting groups
Age, Categorical <=18 years	511 Participants n=5 Participants	236 Participants n=7 Participants	747 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	325 Participants n=5 Participants	129 Participants n=7 Participants	454 Participants n=5 Participants
Age, Categorical >=65 years	568 Participants n=5 Participants	80 Participants n=7 Participants	648 Participants n=5 Participants
Sex: Female, Male Female	758 Participants n=5 Participants	245 Participants n=7 Participants	1003 Participants n=5 Participants
Sex: Female, Male Male	646 Participants n=5 Participants	200 Participants n=7 Participants	846 Participants n=5 Participants
Region of Enrollment Canada	1404 participants n=5 Participants	445 participants n=7 Participants	1849 participants n=5 Participants

PRIMARY outcome

Timeframe: up to 15 years

Outcome measures

Measure	Confirmed Cases of Influenza A n=1404 Participants Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy	Confirmed Cases of Influenza B n=445 Participants Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
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	23.5 Percentage of participants Interval 22.2 to 24.8	22.1 Percentage of participants Interval 20.1 to 24.1

PRIMARY outcome

Timeframe: upto 15 years

Outcome measures

Measure	Confirmed Cases of Influenza A n=1404 Participants Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy	Confirmed Cases of Influenza B n=445 Participants Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
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	9.0 Percentage of participants	7.0 Percentage of participants

PRIMARY outcome

Timeframe: Upto 15 years

Outcome measures

Measure	Confirmed Cases of Influenza A n=1404 Participants Laboratory confirmed cases of influenza A diagnosed by PCR, viral culture or florescence microscopy	Confirmed Cases of Influenza B n=445 Participants Laboratory confirmed cases of influenza B diagnosed by PCR, viral culture or florescence microscopy
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	4.5 percentage of participants	2.0 percentage of participants

Adverse Events

Confirmed Cases of Influenza A

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Confirmed Cases of Influenza B

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Salah Mahmud

Unversity of Manotiba

Phone: 204-272-3139

Email: salah.mahmud@umanitoba.ca

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place