Prevention of Arrhythmia Device Infection Trial (PADIT)
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study|
- Hospitalization attributed to device infection [ Time Frame: Evaluation is one year post patient's procedure ] [ Designated as safety issue: No ]
- 1. Proven device infection not requiring surgical intervention (medically treated device infection). [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
- 2. Any treatment with antibiotics for suspected device infection. [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
- 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection. [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
- 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy. [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
- Cost benefit analysis [ Time Frame: At completion of data collection period ] [ Designated as safety issue: No ]
- 6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause). [ Time Frame: Up to one year post procedure ] [ Designated as safety issue: No ]
|Study Start Date:||December 2012|
|Estimated Study Completion Date:||March 2018|
|Estimated Primary Completion Date:||December 2017 (Final data collection date for primary outcome measure)|
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.
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).
Please refer to this study by its ClinicalTrials.gov identifier: NCT01628666
|Contact: Kim Simek||905-527-4322 ext 40524|
|Coordinating Centre: Population Health Research Institute||Recruiting|
|Hamilton, Ontario, Canada, L8L 2X2|
|Principal Investigator: Carlos Morillo|
|Principal Investigator:||Andrew Krahn, MD||University of British Columbia|