This trial is active, not recruiting.

Condition arrhythmia
Treatments incremental, conventional
Phase phase 4
Sponsor Population Health Research Institute
Collaborator Canadian Institutes of Health Research (CIHR)
Start date December 2012
End date September 2017
Trial size 12814 participants
Trial identifier NCT01628666, PADIT Cluster Crossover Study


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model crossover assignment
Masking open label
Primary purpose prevention
Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
conventional Cefazolin
Cefazolin preoperative
Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.
incremental Cefazolin
Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.

Primary Outcomes

Hospitalization attributed to device infection
time frame: Evaluation is one year post patient's procedure

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: 1. Age >= 18 years 2. Received one of the following procedures: 1. A second or subsequent procedure on the arrhythmia device pocket: ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement 2. Pocket or lead revision 3. System upgrade (insertion or attempted insertion of leads) 4. New cardiac resynchronization therapy device implant (pacemaker or ICD) 3. Patient is not known to have device infection at the time of the surgery

Additional Information

Official title Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
Principal investigator Andrew Krahn, MD
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).
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Population Health Research Institute.