Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

Arrythmias Clinical Trial

— PADIT  

Official title:

Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01002911
• Other study ID #: PADIT
• Status: Completed
• Phase: Phase 3
• First received: October 27, 2009
• Last updated: May 14, 2013
• Start date: December 2009
• Est. completion date: January 2012

Study information

• Verified date: May 2013
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial Summary

The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk patients undergoing arrhythmia device procedures. All antibiotics are approved for use and readily available.

Description:

Infection can occur after surgery for either a pacemaker or an implantable defibrillation and can have very serious consequences. These infections are common and can be seen in as many as 2-3% of high-risk patients. Doctors use antibiotics to prevent these infections, but we do not know how much or how often to give the antibiotics to get the best effect. It is not known whether additional antibiotics during and after the operation would further reduce the risk of infection. This research study will compare two different ways of using common antibiotics to prevent infection during and following a device procedure. One way is the standard approach of a single dose before surgery and the other way uses more antibiotics. We do not know if either way is better. The purpose of this study therefore, is to compare two types of antibiotic therapy plans to better understand if one is most effective in preventing infection.

This study will provide the ability to evaluate the feasibility (i.e. site activation, enrollment, compliance, drop-out) and generate proof of concept for the larger clinical trial of 12,000 patients in all 25 Canadian Hospitals implanting ICDs, which will be submitted to the CIHR. Additionally, the study supports the continued initiatives of the network of physician investigators (Canadian Heart Rhythm Society Device Advisory Committee

• CHRS DAC) collaborating to address arrhythmia procedures related clinical trials that will answer simple clinical questions that will focus initially on safety issues.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 500
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• > 18 years

• One of the following planned device procedures:

• ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement or

• Pocket or lead revision or

• System upgrade (insertion or attempted insertion of leads) or

• New cardiac resynchronization therapy device implant (pacemaker or ICD)

Exclusion Criteria:

• Unable or unwilling to provide written informed consent

• Unable or unwilling to complete the study follow-up schedule

• Life expectancy < 12 months as per the opinion if the local investigator

• Allergy to or unable to tolerate cefazolin or clindamycin or vancomycin

• Allergy to or unable to tolerate intracavitary bacitracin or gentamicin or cefazolin

• Previously enrolled in this trial

• In another study that would confound the results of this trial

Study Design

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

Related Conditions & MeSH terms

• Arrythmias

Intervention

Drug:
• Cefazolin, Bacitracin, Cefalexin
Single does of Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision, Bacitracin wash, Cefalexin 250-500 mg TID
• Cefazolin
Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision

Locations

Country	Name	City	State
Canada	Institut universitaire de cardiologie et de pneumologie de Quebec	Ste-Foy	Quebec

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.		Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur.	No
Secondary	1. Any treatment with antibiotics for suspected device infection.		Patients will have one follow-up visit at 12 months	No
Secondary	2. Antibiotic therapy related adverse event.		Patients will have one follow-up visit at 12 months	No
Secondary	3. Prolongation of hospitalization due to proven or suspected adverse events from the hospitalization.		Patients will have one follow-up visit at 12 months	No