Clinical trial NCT01628666: Prevention of Arrhythmia Device Infection Trial (PADIT)
Official title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Arrhythmia
Keywords: Arrhythmia
Device Procedure
Antibiotics
Infection
Cluster
Lead sponsor: Population Health Research Institute
Sponsor class: OTHER
Collaborators: name: Canadian Institutes of Health Research (CIHR)
First posted: 2012-06-27
Enrollment: 12814
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: PREVENTION

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.

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).

Eligibility criteria: 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

Primary outcomes:
measure: Hospitalization attributed to device infection
timeFrame: Evaluation is one year post patient's procedure
Secondary outcomes:
measure: 1. Proven device infection not requiring surgical intervention (medically treated device infection).
timeFrame: Up to one year post procedure
measure: 2. Any treatment with antibiotics for suspected device infection.
timeFrame: Up to one year post procedure
measure: 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.
timeFrame: Up to one year post procedure
measure: 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.
timeFrame: Up to one year post procedure
measure: Cost benefit analysis
timeFrame: At completion of data collection period
measure: 6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).
timeFrame: Up to one year post procedure
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: Coordinating Centre: Population Health Research Institute
state: Ontario
Study officials:
affiliation: University of British Columbia
name: Andrew Krahn, MD
role: PRINCIPAL_INVESTIGATOR
References: