Prevention of Arrhythmia Device Infection Trial (PADIT)

Condition(s) targeted: Arrhythmia

Intervention: Incremental (Drug); Conventional (Drug)

Phase: Phase 4

Status: Recruiting

Sponsored by: Population Health Research Institute

Official(s) and/or principal investigator(s):
Andrew Krahn, MD, Principal Investigator, Affiliation: University of British Columbia

Overall contact:
Kim Simek, Phone: 905-527-4322, Ext: 40524

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.

Official title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Prevention

Primary outcome: Hospitalization attributed to device infection

Secondary outcome:

1. Proven device infection not requiring surgical intervention (medically treated device infection).

2. Any treatment with antibiotics for suspected device infection.

3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.

4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.

Cost benefit analysis

6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).

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).

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

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

Kim Simek, Phone: 905-527-4322, Ext: 40524

Coordinating Centre: Population Health Research Institute, Hamilton, Ontario L8L 2X2, Canada; Recruiting
Carlos Morillo, Principal Investigator

Starting date: December 2012
Last updated: February 3, 2015