- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01628666
Prevention of Arrhythmia Device Infection Trial (PADIT)
Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
This is a randomized prospective cluster crossover trial to track outcomes of high infection risk patients undergoing arrhythmia device procedures. Centres will be randomized to either conventional antibiotic therapy or incremental antibiotic therapy. Patients will not be randomized. Centres will be randomized to one therapy and then cross over to the next after 6 months. At one year they will randomize again and then cross over for the final time at 18 months. During each treatment period the randomized antibiotic therapy will be used on all centre patients undergoing a device implant procedure.
Ethics approval has been obtained in all sites for waiver of consent with notification of the study (i.e. data collection is taking place to track infection rates). A third of sites obtain consent after the procedure for collection of data (but not for care, since either arm is the standard of care).
Study Type
Enrollment (Actual)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8L 2X2
- Coordinating Centre: Population Health Research Institute
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Conventional
Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
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Cefazolin preoperative
Other Names:
|
Experimental: Incremental
Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.
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Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospitalization attributed to device infection
Time Frame: Evaluation is one year post patient's procedure
|
Evaluation is one year post patient's procedure
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
1. Proven device infection not requiring surgical intervention (medically treated device infection).
Time Frame: Up to one year post procedure
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Up to one year post procedure
|
2. Any treatment with antibiotics for suspected device infection.
Time Frame: Up to one year post procedure
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Up to one year post procedure
|
3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.
Time Frame: Up to one year post procedure
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Up to one year post procedure
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4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.
Time Frame: Up to one year post procedure
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Up to one year post procedure
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Cost benefit analysis
Time Frame: At completion of data collection period
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At completion of data collection period
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6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).
Time Frame: Up to one year post procedure
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Up to one year post procedure
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Andrew Krahn, MD, University of British Columbia
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- PADIT Cluster Crossover Study
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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