Prevention of Arrhythmia Device Infection Trial (PADIT Pilot) (PADIT)

Study Description

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Brief 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.

Condition or disease	Intervention/treatment	Phase
Arrythmias	Drug: Cefazolin, Bacitracin, Cefalexin; Drug: Cefazolin	Phase 3

Detailed 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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	500 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	None (Open Label)
Primary Purpose:	Prevention
Official Title:	Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection
Study Start Date :	December 2009
Actual Primary Completion Date :	January 2012
Actual Study Completion Date :	January 2012

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Aggressive Antibiotic therapy; Patients receive preoperative intravenous antibiotics, intracavitary antibiotics during surgery and postoperative antibiotics.	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
Active Comparator: Conventional Antibiotic Therapy; Preoperative intravenous antibiotics	Drug: Cefazolin; Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision

Outcome Measures

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Primary Outcome Measures :

1. Hospitalization attributed to device infection. [ Time Frame: Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur. ]

Secondary Outcome Measures :

1. 1. Any treatment with antibiotics for suspected device infection. [ Time Frame: Patients will have one follow-up visit at 12 months ]
2. 2. Antibiotic therapy related adverse event. [ Time Frame: Patients will have one follow-up visit at 12 months ]
3. 3. Prolongation of hospitalization due to proven or suspected adverse events from the hospitalization. [ Time Frame: Patients will have one follow-up visit at 12 months ]

Eligibility Criteria

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Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

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Locations

Canada, Quebec
Institut universitaire de cardiologie et de pneumologie de Quebec
Ste-Foy, Quebec, Canada, G1V 4G5

Sponsors and Collaborators

Population Health Research Institute

Investigators

Principal Investigator:	Dr. Andrew Krahn	University of British Columbia

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Population Health Research Institute
ClinicalTrials.gov Identifier:	NCT01002911 History of Changes
Other Study ID Numbers:	PADIT
First Posted:	October 28, 2009
Last Update Posted:	May 16, 2013
Last Verified:	May 2013

Keywords provided by Population Health Research Institute:

Device procedure; pacemaker; ICD; antibiotics

Additional relevant MeSH terms:

Anti-Bacterial Agents; Cefazolin; Cephalexin; Bacitracin	Antibiotics, Antitubercular; Anti-Infective Agents; Antitubercular Agents; Anti-Infective Agents, Local