Prevention of Arrhythmia Device Infection Trial (PADIT)
1 other identifier
interventional
12,814
1 country
1
Brief Summary
The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_4
Started Dec 2012
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 4, 2012
CompletedFirst Posted
Study publicly available on registry
June 27, 2012
CompletedStudy Start
First participant enrolled
December 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 8, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
September 8, 2017
CompletedJune 24, 2019
June 1, 2019
4.8 years
June 4, 2012
June 20, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospitalization attributed to device infection
Evaluation is one year post patient's procedure
Secondary Outcomes (6)
1. Proven device infection not requiring surgical intervention (medically treated device infection).
Up to one year post procedure
2. Any treatment with antibiotics for suspected device infection.
Up to one year post procedure
3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.
Up to one year post procedure
4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.
Up to one year post procedure
Cost benefit analysis
At completion of data collection period
- +1 more secondary outcomes
Study Arms (2)
Conventional
EXPERIMENTALPreoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
Incremental
EXPERIMENTALPreoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.
Interventions
Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
Eligibility Criteria
You may qualify if:
- Age \>= 18 years
- Received one of the following procedures:
- A second or subsequent procedure on the arrhythmia device pocket:
- ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement
- Pocket or lead revision
- System upgrade (insertion or attempted insertion of leads)
- New cardiac resynchronization therapy device implant (pacemaker or ICD)
- Patient is not known to have device infection at the time of the surgery
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Coordinating Centre: Population Health Research Institute
Hamilton, Ontario, L8L 2X2, Canada
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Andrew Krahn, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 4, 2012
First Posted
June 27, 2012
Study Start
December 1, 2012
Primary Completion
September 8, 2017
Study Completion
September 8, 2017
Last Updated
June 24, 2019
Record last verified: 2019-06