Prevention of Arrhythmia Device Infection Trial (PADIT)
Information source: Population Health Research Institute
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Arrhythmia
Intervention: Incremental (Drug); Cefazolin (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Population Health Research Institute Official(s) and/or principal investigator(s): Dr. Andrew Krahn, M.D, Principal Investigator, Affiliation: University of British Columbia
Summary
The goal of the pilot study is to compare whether a centre-wide policy of incremental
antibiotic therapy will reduce pacemaker infection compared to a policy of conventional
antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This
pilot study will provide feasibility information for a larger cluster randomized crossover
design (CRCD).
Clinical Details
Official title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Hospitalization attributed to device infection
Detailed description:
Multi-center, cluster crossover, unblinded, pilot study. Centers will be randomized to
conventional vs. incremental antibiotic therapy for 2 months or until eligible 20 patients
are treated, whichever comes first. At 2 months, centers will have a crossover period of 4
weeks where the alternate strategy is implemented, followed by the final 2-month/20 patient
enrolment period. During each treatment period the randomized antibiotic strategy will be
used on all center patients undergoing a device implant procedure. Prior to the planned
surgery or at the first follow up visit, patients who meet the study eligibility criteria
will be approached to obtain consent for data collection purposes. Follow up will be
according to usual clinical care at the center.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- > 18 years
- received one of the following procedures:
1. a second or subsequent procedure on the arrhythmia device pocket: i. ICD,
pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead
revision iii. system upgrade (insertion or attempted insertion of leads)
2. new cardiac resynchronization therapy device implant (pacemaker or ICD)
Exclusion Criteria:
- life expectancy < 12 months in the opinion of the local investigator.
- allergy or unable to tolerate cefazolin or clindamycin or vancomycin.
- allergy or unable to tolerate intracavitary bacitracin identified per-operatively.
- pre-operative identification that the patient has infection.
Locations and Contacts
Hamilton General Hospital, McMaster University, Hamilton, Ontario L8L 2X2, Canada
University of Ottawa Heart Institute, Ottawa, Ontario K1Y 4W7, Canada
Additional Information
Starting date: May 2011
Last updated: October 9, 2014
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