Community-acquired Pneumonia Clinical Trial
Official title:
Proton Pump Inhibitors and the Risk of Hospitalization for Community-acquired Pneumonia: Replicated Cohort Studies With Meta-analysis
Verified date | September 2015 |
Source | Canadian Network for Observational Drug Effect Studies, CNODES |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The purpose of the study is to determine whether proton pump inhibitors (PPIs), a medication
used to treat gastric conditions, increase the risk of hospitalization for community-acquired
pneumonia (HCAP).
The investigators will carry out separate population-based cohort studies using
administrative health databases in eight jurisdictions in Canada, the US, and the UK. Cohort
entry will be defined by the initiation of an oral non-steroidal anti-inflammatory drug, with
follow-up until hospitalization for pneumonia or end of follow-up (6 months). The results
from the separate sites will be combined using a statistical approach called meta-analysis to
provide an overall assessment of the risk of HCAP with PPIs.
Status | Completed |
Enrollment | 4238504 |
Est. completion date | February 2012 |
Est. primary completion date | February 2012 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 40 Years and older |
Eligibility |
Inclusion Criteria: - Patients with a first oral NSAID prescription - Patients at least 40 years of age (except Alberta, Ontario, and Nova Scotia, where patients will be at least 66 years of age) - Patients with at least 1 year of history in the database. Exclusion Criteria: - Patients aged < 40 years at cohort entry (or < 66 in Alberta, Ontario, and Nova Scotia) - Received a prescription for a PPI, a H2RA, or a NSAID (any route of administration) in the 6 months prior to cohort entry - Had an HCAP (ICD-9-CM code (in any field): 480.x-487.x; ICD-10-CA code: J10.0 - J18.9) or an extended emergency room visit for community-acquired pneumonia in the year prior to cohort entry (where available) - Hospitalized at the time of cohort entry - Received a prescription for medications used for the treatment of tuberculosis (ATC Code J04A) (where available) - Had a history of cancer (other than non-melanoma skin cancer) in the year prior to cohort entry - Hospitalized >3 days within the 30 days before cohort entry - Had <1 year of continuous observation time in the database prior to cohort entry |
Country | Name | City | State |
---|---|---|---|
Canada | Lady Davis Institute for Medical Research, Jewish General Hospital | Montreal | Quebec |
Lead Sponsor | Collaborator |
---|---|
Canadian Network for Observational Drug Effect Studies, CNODES | Canadian Institutes of Health Research (CIHR), Drug Safety and Effectiveness Network, Canada |
Canada,
Filion KB, Chateau D, Targownik LE, Gershon A, Durand M, Tamim H, Teare GF, Ravani P, Ernst P, Dormuth CR; CNODES Investigators. Proton pump inhibitors and the risk of hospitalisation for community-acquired pneumonia: replicated cohort studies with meta-a — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Hospitalization for Community-Acquired Pneumonia (HCAP) | HCAP during the 6 months following cohort entry Patients with HCAP with any of the following diagnostic codes: ICD-9: 487.0, 487.1, 487.0, 487.1, 487.0, 480.9, 481.x, 482.2, 482.0, 482.1, 482.30, 482.31, 482.32, 482.39, 482.40, 482.41, 482.42, 482.49, 482.81, 482.82, 482.83, 482.89, 482.9, 483.0, 484.7, 484.8, 485.X, 481.X, 486.X ; ICD-10: J10.0, J11.0, J11.1, J12.9, J13, J14, J15.X, J16.8, J17.0, J17.2, J17.3, J17.8, J18.0, J18.1, J18.8, J18.9. |
Patients will be followed from the date of study cohort entry until HCAP, censoring, or for up to 6 months. |
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