Study Type
Interventional - Drug
completed
The objective of the PADIT Pilot study was to compare a conventional antibiotic therapy approach to an aggressive antibiotic therapy for the prevention of hospitalization for device infection in high-risk patients undergoing arrhythmia device procedures.
Eligible and consenting patients were randomized to conventional (pre-op antibiotics) or aggressive antibiotics (pre-op, intra-op and post-op) for the prevention of infection prior to the planned device procedure.
Patients had a follow up 12 months post-implant to determine if they met the primary outcome for hospitalization for device infection.
Primary endpoint:
Hospitalization attributed to device infection; device infection not requiring surgical intervention; treatment with antibiotics for suspected device infection; antibiotic related adverse events; prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy; and cost-benefit analysis.
Co-Principal Investigator on this study was Andrew Krahn, Professor, Head of Division of Cardiology, Department of Medicine, University of British Columbia.
Study Design
Randomized pilot
NO. of Countries
1
NO. of Sites
11
NO. of Participants
500
Study Period
2009-2010
Sponsor
PHRI
Stuart Connolly
Stuart Connolly
Stuart Connolly is a Professor of Medicine at McMaster University and a cardiac electrophysiologist at Hamilton Health Sciences. He became a faculty member at McMaster University in 1983 and was awarded a full professorship in 1994. He was also appointed as the inaugural holder of the Salim Yusuf Chair in Cardiology at McMaster University.
He has published more than 270 scientific articles in the field, and is currently a member of the editorial boards for a number of prominent cardiology journals, including Heart, the American Heart Journal and the Journal of Pacing and Electrophysiology. His main research interests are focused on the evaluation of treatments for heart rhythm disorders. His academic career has been largely devoted to the design and execution of controlled clinical trials in this area.
He holds a Masters degree from Fordham University, New York, and an MD from McGill University in Montreal. He received his specialist training in cardiology at the University of Toronto and at Stanford University.
Ellison Themeles
Associate Program Manager
Ellison Themeles
Associate Program Manager
Ellison Themeles’ experience includes more than 20 years in the conduct, execution and management of large, international clinical trials involving both medical devices and pharmaceutical agents in the area of cardiovascular disease and arrhythmias.
She holds a Bachelor of Arts degree in Gerontology and Sociology, and a Master of Science Degree in Health Research Methodology, from McMaster University.
Canadian Institutes of Health Research (CIHR)
completed
PADIT Cluster Crossover
Arrhythmia & Heart Failure
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completed
PADIT Cluster Crossover Pilot
Arrhythmia & Heart Failure
The objective of the PADIT Cluster Crossover Pilot study was to compare whether a centre-wide...
