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Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults (SOS-VE01)

This study is currently recruiting participants.
Verified January 2012 by Dalhousie University
Sponsor:
Collaborators:
Public Health Agency of Canada (PHAC)
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Information provided by (Responsible Party):
Dalhousie University
ClinicalTrials.gov Identifier:
NCT01517191
First received: January 17, 2012
Last updated: January 20, 2012
Last verified: January 2012
History of Changes
  Purpose

This surveillance study will include all consenting adults hospitalized with influenza (cases) at the SOS network of hospitals as well as influenza negative patients(controls), to assess vaccine effectiveness in each group. Both groups will be followed throughout their hospitalization and for 30 days post discharge to monitor severity of illness and outcomes following their illness.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Sentinel Surveillance for Influenza Requiring Hospital Admission Canadian Adults

Resource links provided by NLM:

MedlinePlus related topics: Flu
U.S. FDA Resources

Further study details as provided by Dalhousie University:

Primary Outcome Measures:
  • Estimate the burden of influenza disease and influenza vaccine effectiveness. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 65 years of age.


Secondary Outcome Measures:
  • Estimate the burden of influenza disease and influenza vaccine effectiveness. [ Time Frame: 1 Year ] [ Designated as safety issue: No ]
    Occurrence of any PCR-confirmed influenza virus infection in vaccinated (>14 days after receipt of seasonal influenza vaccine) or unvaccinated adults ≥ 16 years of age


Biospecimen Retention:   Samples Without DNA

Serum and Nasopharyngeal swabs


Estimated Enrollment: 2400
Study Start Date: November 2011
Estimated Study Completion Date: August 2014
Estimated Primary Completion Date: May 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
Influenza Positive Case
Influenza cases are hospitalized adults who have tested positive for influenza.
Influenza Negative Control
Control Controls are hospitalized adults who have tested negative for influenza.

Detailed Description:

The Public Health Agency of Canada/Canadian Institutes of Health Research Influenza Research Network (PCIRN) is a collaborative research network which brings together over 100 investigators in over 40 institutions to evaluate all factors relevant to the introduction of a pandemic influenza vaccine in Canada. The Serious Outcomes Surveillance (SOS) Network within PCIRN was established in 2009 to plan for evaluation of influenza vaccine safety and effectiveness. Vaccine effectiveness studies are critical in assessing vaccine effectiveness under real world conditions and in assessing vaccine effectiveness in the prevention of severe outcomes. Establishing the methodology and infrastructure for real-time field assessment of vaccine effectiveness is crucial to inform policy recommendations for the optimal use of resources, including vaccines.

This study will include all consenting adult patients hospitalized at one of the SOS Network hospitals during influenza season who test positive for influenza (cases). In addition two influenza negative controls will be matched to each case to measure differences in vaccine effectiveness. Specific study aims are:

  1. To determine the effectiveness of trivalent influenza vaccination (TIV in general, and GSK TIV in particular) in preventing influenza-associated hospitalization in adults ≥ 65 years,
  2. To determine the effectiveness of influenza vaccination in preventing influenza-associated death in adults ≥ 65 years
  3. To determine the effectiveness of influenza vaccination in preventing influenza-associated hospitalization and death in adults < 65 years
  4. To characterize the burden of disease, clinical outcomes, and resource utilization associated with influenza A and influenza B lineages
  5. To examine clinical and immunologic factors impacting on severity of disease and influenza vaccine effectiveness in adults
  Eligibility

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

This observational study is open to adults admitted to hospital with test postitive influenza or with an influenza like illness who test negative.

Criteria

Inclusion Criteria:

  • Adult patients ≥ 16 years of age admitted to participating SOS Network hospitals with the following admitting diagnoses will be eligible for screening within 5 days of admission:
  • community-acquired pneumonia
  • acute exacerbation of chronic obstructive pulmonary disease (AECOPD) or asthma
  • unexplained sepsis
  • Any other respiratory infection or diagnosis Or any respiratory or influenza-like symptom )(eg dyspnea, cough, sore throat, myalgia, arthralgia, fever)

One day per week, beginning when the local laboratory reports influenza positivity rates of ≥ 5% of all tests submitted, patients admitted with the following will also be screened:

  • Acute coronary syndrome (eg myocardial infarction, unstable angina) with a triage temperature ≥37.5°C
  • Any other cardiac diagnosis (eg atrial fibrillation, other arrhythmia, myocarditis) with a triage temperature ≥ 37.5°C
  • Stroke with a triage temperature ≥37.5°C

Exclusion Criteria:

  • Patients whose reason for admission was clearly unrelated to the presence of influenza (for example, patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not cardiac, respiratory, or neurologic, e.g. cellulitis, intra-abdominal process, or gastrointestinal bleeding)
  • Patients testing positive (cases) for whom immunization status cannot be ascertained will be excluded from the vaccine effectiveness analysis component of the study, however, they will still be enrolled and will be included in the burden of influenza
  • Patients testing negative for influenza (controls) for whom immunization status cannot be ascertained (by verbal self report or other source) will not be eligible for enrolment
  • No children in care will be enrolled in the study
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01517191

Contacts
Contact: Shelly A McNeil, MD, FRCPC 902-470-8141 shelly.mcneil@cdha.nshealth.ca

Locations
Canada, British Columbia
Vancouver General Recruiting
Vancouver, British Columbia, Canada
Contact: Grant Stiver, MD     604-875-4146     gstiver@interchange.ubc.ca    
Contact: William Bowie, MD            
Canada, Manitoba
St. Boniface Hospital Not yet recruiting
Winnipeg, Manitoba, Canada
Contact: Bruce Light, MD     204-237-2948     light@cc.umanitoba.ca    
Contact: Phillipe Lagace Wiens, MD         plagacewiens@dsmanitoba.ca    
Canada, New Brunswick
Saint John Regional Hospital Recruiting
Saint John, New Brunswick, Canada
Contact: Duncan Webster, MD     506-648-6807     Duncan.webster@horizonNB.ca    
Canada, Nova Scotia
QEII Health Science Centre Recruiting
Halifax, Nova Scotia, Canada, B3K 6R8
Contact: Shelly A McNeil, MD     902-470-8141     Shelly.mcneil@cdha.nshealth.ca    
Principal Investigator: Shelly A McNeil, MD            
Canada, Ontario
McMaster Recruiting
Hamilton, Ontario, Canada
Contact: Mark Loeb, MD     905-525-9140 ext 26066     loebm@mcmaster.ca    
Contact: Jennie Johnston, MD         johnsj48@mcmaster.ca    
Ottawa General Recruiting
Ottawa, Ontario, Canada
Contact: Anne McCarthy, MD     613-737-8184     amccarthy@Ottawahospital.on.ca    
Mount Sinai Recruiting
Toronto, Ontario, Canada
Contact: Allison McGeer, MD     (416) 586-3118     amcgeer@mtsinai.on.ca    
Canada, Quebec
MUCH Recruiting
Montreal, Quebec, Canada
Contact: Makeda Semret, MD     514-345-3511     makeda.semret@mcgill.ca    
CHUS Recruiting
Sherbrooke, Quebec, Canada
Contact: Loius Valiquette, MD     819 346-1110 ext 12568     Louis.Valiquette@USherbrooke.ca    
Canada
CHUl/CHUQ Recruiting
Quebec, Canada, Canada
Contact: Guy Boivin, MD     (418) 654-2705     Guy.boivin@crchul.ulaval.ca    
Contact: Sylvie Trottier, MD         Sylvie.trottier@crchul.ulaval.ca    
Sponsors and Collaborators
Dalhousie University
Public Health Agency of Canada (PHAC)
Canadian Institutes of Health Research (CIHR)
GlaxoSmithKline
Investigators
Principal Investigator: Shelly A McNeil, MD Dalhousie University
  More Information

No publications provided

Responsible Party: Dalhousie University
ClinicalTrials.gov Identifier: NCT01517191     History of Changes
Other Study ID Numbers: SOS-VE01
Study First Received: January 17, 2012
Last Updated: January 20, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Dalhousie University:
Influenza
Respiratory Infection

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 May 21, 2013