Prevention of Arrhythmia Device Infection Trial (PADIT)

NCT ID: NCT01613092

Last Updated: 2014-10-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 241 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2011-05-31
• Study Completion Date: 2013-12-31

Brief Summary

The goal of the pilot study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce pacemaker infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This pilot study will provide feasibility information for a larger cluster randomized crossover design (CRCD).

Detailed Description

Multi-center, cluster crossover, unblinded, pilot study. Centers will be randomized to conventional vs. incremental antibiotic therapy for 2 months or until eligible 20 patients are treated, whichever comes first. At 2 months, centers will have a crossover period of 4 weeks where the alternate strategy is implemented, followed by the final 2-month/20 patient enrolment period. During each treatment period the randomized antibiotic strategy will be used on all center patients undergoing a device implant procedure. Prior to the planned surgery or at the first follow up visit, patients who meet the study eligibility criteria will be approached to obtain consent for data collection purposes. Follow up will be according to usual clinical care at the center.

Conditions

Arrhythmia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: PREVENTION
• Blinding Strategy: NONE

Study Groups

Conventional

Preoperative Antibiotics

Group Type: EXPERIMENTAL

Cefazolin

Intervention Type: DRUG

Preoperative antibiotic

Aggressive (Incremental)

Preoperative antibiotics, antibiotic wash and post operative antibiotics

Group Type: ACTIVE_COMPARATOR

Incremental

Intervention Type: DRUG

Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin

Interventions

Incremental

Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin

Intervention Type: DRUG

Cefazolin

Preoperative antibiotic

Intervention Type: DRUG

Other Intervention Names

Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin

Eligibility Criteria

Inclusion Criteria

• > 18 years
• received one of the following procedures:

1. a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)

2. new cardiac resynchronization therapy device implant (pacemaker or ICD)

Exclusion Criteria

• life expectancy < 12 months in the opinion of the local investigator.
• allergy or unable to tolerate cefazolin or clindamycin or vancomycin.
• allergy or unable to tolerate intracavitary bacitracin identified per-operatively.
• pre-operative identification that the patient has infection.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Population Health Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Dr. Andrew Krahn, M.D

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Hamilton General Hospital, McMaster University

Hamilton, Ontario, Canada

University of Ottawa Heart Institute

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

PADIT Cluster Crossover Pilot

Identifier Type: -

Identifier Source: org_study_id