NCT01683630

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,849

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2012

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2012

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 31, 2012

Completed
1 day until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2012

Completed
11 days until next milestone

First Posted

Study publicly available on registry

September 12, 2012

Completed
3.1 years until next milestone

Results Posted

Study results publicly available

October 19, 2015

Completed
Last Updated

October 10, 2016

Status Verified

August 1, 2016

Enrollment Period

5 months

First QC Date

August 31, 2012

Results QC Date

June 30, 2015

Last Update Submit

August 29, 2016

Conditions

Keywords

InfluenzaInfluenza type AInfluenza type BhospitalizationManitobaCanada

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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

Study Arms (1)

Confirmed influenza A and B cases

Cases of influenza A and B as diagnosed by PCR, viral culture or florescence microscopy

Eligibility Criteria

Age6 Months+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Infectious Diseases

Winnipeg, Manitoba, R3B 3P5, Canada

Location

Related 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.

MeSH Terms

Conditions

Influenza, Human

Condition Hierarchy (Ancestors)

Respiratory Tract InfectionsInfectionsOrthomyxoviridae InfectionsRNA Virus InfectionsVirus DiseasesRespiratory Tract Diseases

Results Point of Contact

Title
Salah Mahmud
Organization
Unversity of Manotiba

Study Officials

  • Salah Mahmud, MD, PhD

    Associate Professor, University of Manitoba

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 31, 2012

First Posted

September 12, 2012

Study Start

April 1, 2012

Primary Completion

September 1, 2012

Study Completion

September 1, 2012

Last Updated

October 10, 2016

Results First Posted

October 19, 2015

Record last verified: 2016-08

Data Sharing

IPD Sharing
Will not share

Locations