Prevention of Arrhythmia Device Infection Trial (PADIT)

Arrhythmia Clinical Trial

Official title:

Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01613092
• Other study ID #: PADIT Cluster Crossover Pilot
• Status: Completed
• Phase: Phase 4
• First received: June 4, 2012
• Last updated: October 9, 2014
• Start date: May 2011
• Est. completion date: December 2013

Study information

• Verified date: October 2014
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 241
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Arrhythmia

Intervention

Drug:
• Incremental
Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin
• Cefazolin
Preoperative antibiotic

Locations

Country	Name	City	State
Canada	Hamilton General Hospital, McMaster University	Hamilton	Ontario
Canada	University of Ottawa Heart Institute	Ottawa	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization attributed to device infection	Hospitalization attributed to device infection	within one year of device procedure	No