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Population based surveillance for invasive pneumococcal disease

Status:  Currently Recruiting

Why are we doing this?

S. pneumoniae is the most common cause of bacterial pneumonia in adults, and the most common cause of bacteremia, bacterial otitis media and meningitis in infants and children. Over the past decade many of these bacteria have become resistant to the antibiotics commonly used to treat them. As a result there has been a focus on vaccination programs for both children, older adults and people with medical conditions that put them at risk for pneumococcal disease.

The TIBDN pneumococcal surveillance program allows us to determine factors that put people at risk for pneumococcal disease and infection with antibiotic resistant bacteria.

In addition, we can evaluate the effect of newer antibiotics and vaccines on the incidence of disease and the prevalence of antimicrobial resistance.

Study Objectives

  • to detect the occurrence of invasive and respiratory disease due to Streptococcus pneumoniae
  • to assess the efficacy of pneumococcal vaccination programs for adults and children
  • to detect changes in serotype and epidemiology of illness due to Streptococcus pneumoniae which may be associated with the introduction of the new conjugate vaccines
  • to assess risk factors for infection with antibiotic resistant Streptococcus pneumoniae
  • to determine the effect of dose and duration of antimicrobial exposure on risk of isolation of antibiotic resistant Streptococcus pneumoniae from community-dwelling seniors
     

Who is being asked to participate?

  • Anyone admitted to a hospital and has had a sterile site (eg. blood, cerebralspinal fluid) or respiratory sample (eg. sputum, bronchoscopy samples) which has tested positive for Streptococcus pneumoniae

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

If you agree to participate you will be consenting to:

  • An interview with the study staff, who will ask you about your health status, vaccination history, and previous use of antibiotics
  • The study obtaining information about your medical history from your physician and, if applicable, from your hospital chart
  • The study obtaining information about your medical history from your physician and, if applicable, from your hospital chart
  • A sample of the bacterium which caused your infection being sent from the hospital to the study laboratory at Mount Sinai Hospital
  • For some people (participants over the age of 65 who give consent), we will anonymously link data on resistance (eg. infection with resistant organism) from the study data base to information on antibiotic prescriptions in the 12 months before you became ill from the Ontario Drug Benefit data base (the health plan that pays for medications for those over age 65). Health card numbers will be encrypted (altered by a computer) so that information from your records can never be linked directly to the participant.
  • If you live in Toronto or Region of Peel, the transfer of information about infections of the blood or meningitis to the public health department (unless you sign a waiver requesting that we do not do so).

Are there any risks to participating in this study?

There are no risks for you in taking part in this study. You are not being given any medication and no change in your treatment will result from your participation. You may find the interviews or questions upsetting or distressing or you may not like all of the questions that you are asked. You may refuse to answer questions or stop the interview at any time if you are uncomfortable. We take every precaution to protect your personal information. Any information and left-over test sample you provide to the study is confidential and is identified only by a study code number. No one will be able to identify the study information or sample as belonging to you.

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

Call the study office at Mount Sinai Hospital, 416-586-4800, ext. 2761 or 1-800-668-6292.

You will be directed to the TIBDN reseach personnel assigned to the hospital where you were admitted.

Investigators

Dr. Allison McGeer, Principal Investigator

Click here for full investigator list

Funding partners

TIBDN has received funding to support surveillance for invasive pneumococcal disease from: Canadian Institutes for Health Research, Ontario Thoracic Society, the US Centers for Disease Control and Prevention, Abbott Laboratories of Canada, Bayer Healthcare AG, GlaxoSmithKline Inc., and Pfizer, Inc. 

Ethics

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

Participating TIBDN Sites