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Sentinel surveillance for pneumococcal disease among hospitalized Canadian adults

Status: Currently recruiting

Why are we doing this study?

This study is being done to gather information about the how often Canadian adults are admitted to hospital due to infections caused by different types of the pneumococcus. This is important because new vaccines are being developed to prevent infections. It is important that we understand which pneumococcal infections in adults can be or may in the future be prevented by vaccination. This will help public health officials determine what the best way to use the new vaccines will be. It will also help us in understanding how vaccines can be improved in the future.

Study objectives

  • To describe the frequency and serotype distribution of nasopharyngeal colonization with Streptococcus pneumoniae among adults admitted to sentinel Canadian hospitals with community acquired pneumonia (CAP).
  • To describe the rates (expressed as rate per 1000 hospitalizations) of hospitalized CAP among adults admitted to sentinel hospitals in Canada and to ascertain the contribution and serotype distribution of Streptococcus pneumoniae in hospitalized CAP.
  • To describe the rates and serotype distribution of IPD among adults in sentinel hospitals in Canada.

Who is being asked to participate?

Any patient 16 years of age or older who is admitted to Mount Sinai Hospital with either of the following diagnosis:

  • influenza
  • community-acquired pneumonia
  • other respiratory tract infection
  • acute exacerbation of chronic obstructive pulmonary disease (AECOPD) or asthma
  • invasive pneumococcal disease (has a blood sample or other sterile site specimen eg.cerebrospinal fluid (CSF), pleural fluid, peritoneal fluid, pericardial fluid, surgical aspirate, bone, joint fluid, or internal body site (e.g., lymph node, brain) which tests positive for Streptococcus pneumoniae

If I agree to participate, what will I need to do?

If you agree to participate you will be asked to:

  • be interviewed for approximately 20-30 minutes about your general health, this illness and about which, if any vaccines you have previously received
  • allow the researcher to review your medical chart throughout your hospitalization to collect information about your symptoms and any laboratory tests you might have 
  • allow the researcher to contact your family doctor and/or vaccination clinic to confirm exactly when you received vaccines
  • have a nose swab, sputum specimen, blood sample, urine tests and chest x-rays obtained if they have not already been done in order to diagnose your illness. (You will be told if testing is only for the study, and you will be able to decide for each test whether or not you are willing to have it done).
  • have any left over specimens of blood, the nose swab, sputum samples and urine specimens swab sent to the research lab in Halifax at  the Canadian  Centre for Vaccinology. These samples will be labelled with a confidential study number only and cannot be identified as your specimens
  • allow the study nurse to contact you by phone about 1 month after discharge from the hospital to see how you are feeling and how you are coping at home. This interview will take approximately 15 minutes.

How long will the study last?

This study began in fall of 2010 and will be completed in fall of 2013.  We are currently enrolling subjects.

Are there any risks to participating in this study?

You may experience some temporary discomfort when the blood sample is taken. There is a small risk of bruising, infection, or swelling at the site where the needle is inserted, and some people may feel faint and dizzy.

NP (nasopharyngeal) swabs may performed as part of your medical care, or as part of the study. There may be some discomfort when the swabs are collected. Getting an NP swab done is not painful, but it may tickle and cause your eyes to water.

All information collected during this study, including your personal health information, will be kept confidential and will not be shared with anyone outside the study unless required by law.  Any information about you that is sent out of the hospital will have study code number only and will not show your name or address, or any information that directly identifies you.

Who can I contact if I am interested in the study?

Sofia Anceva-Sami at Mount Sinai Hospital, 416-586-4800, ext. 4312, sanceva-sami@mtsinai.on.ca

Investigators

  • Dr. Allison McGeer, Mount Sinai Hospital
  • Dr. Shelly McNeil, Principal Investigator, Canadian Center for Vaccinology, Halifax

Sponsor

Dalhousie University

Funding partner

This work is funded through an Investigator-Initiated Research Grant provided by Pfizer Canada Inc. The funding partner plays no role in the conduct of the protocol, the data collection, analysis or reporting of results.

Ethics

This study has been approved by the Research Ethics Boards at all participating hospitals.

Participating SOS Network Sites

Queen Elizabeth II Health Sciences Center, the IWK Health Centre and Dartmouth General Hospital in Halifax, NS, the Mount Sinai Hospital in Toronto, ON, Hamilton Health Sciences Centre and St. Joseph’s Hospital in Hamilton, ON, The Ottawa Hospital (Civic Campus and General Campus) in Ottawa, ON, Foothills Medical Centre in Calgary, AB, Centre Hospitalier Universitaire de Quebec ( CHUQ-CHUL) Laval, Vancouver General Hospital, Vancouver BC, and Centre Hospitalier Universitaire de Sherbrooke, Hopital Fleurmont  in Sherbrook, Quebec. Additional adult acute care facilities will be recruited as feasible to provide more representative geographic distribution of sentinel sites within the Network and to provide more robust, region-specific data.

The SOS Network Coordinating Centre is located at the Canadian Center for Vaccinology in Halifax, NS.