Prevention of Arrhythmia Device Infection Trial (PADIT)
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|ClinicalTrials.gov Identifier: NCT01628666|
Recruitment Status : Completed
First Posted : June 27, 2012
Last Update Posted : June 24, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Arrhythmia||Drug: Incremental Drug: Conventional||Phase 4|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||12814 participants|
|Intervention Model:||Crossover Assignment|
|Masking:||None (Open Label)|
|Official Title:||Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study|
|Actual Study Start Date :||December 2012|
|Actual Primary Completion Date :||September 8, 2017|
|Actual Study Completion Date :||September 8, 2017|
Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
Other Name: Cefazolin
Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.
Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
- Hospitalization attributed to device infection [ Time Frame: Evaluation is one year post patient's procedure ]
- 1. Proven device infection not requiring surgical intervention (medically treated device infection). [ Time Frame: Up to one year post procedure ]
- 2. Any treatment with antibiotics for suspected device infection. [ Time Frame: 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 ]
- 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy. [ Time Frame: Up to one year post procedure ]
- Cost benefit analysis [ Time Frame: At completion of data collection period ]
- 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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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01628666
|Coordinating Centre: Population Health Research Institute|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator:||Andrew Krahn, MD||University of British Columbia|
|Responsible Party:||Population Health Research Institute|
|Other Study ID Numbers:||
PADIT Cluster Crossover Study
|First Posted:||June 27, 2012 Key Record Dates|
|Last Update Posted:||June 24, 2019|
|Last Verified:||June 2019|
Anti-Infective Agents, Local