Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute
ClinicalTrials.gov Identifier:
NCT01002911
First received: October 27, 2009
Last updated: May 14, 2013
Last verified: May 2013
  Purpose

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 Intervention Phase
Arrythmias
Drug: Cefazolin, Bacitracin, Cefalexin
Drug: Cefazolin
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection

Resource links provided by NLM:


Further study details as provided by Population Health Research Institute:

Primary Outcome Measures:
  • 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. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 1. Any treatment with antibiotics for suspected device infection. [ Time Frame: Patients will have one follow-up visit at 12 months ] [ Designated as safety issue: No ]
  • 2. Antibiotic therapy related adverse event. [ Time Frame: Patients will have one follow-up visit at 12 months ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 500
Study Start Date: December 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01002911

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

No publications provided

Responsible Party: Population Health Research Institute
ClinicalTrials.gov Identifier: NCT01002911     History of Changes
Other Study ID Numbers: PADIT
Study First Received: October 27, 2009
Last Updated: May 14, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Population Health Research Institute:
Device procedure
pacemaker
ICD
antibiotics

Additional relevant MeSH terms:
Arrhythmias, Cardiac
Heart Diseases
Cardiovascular Diseases
Pathologic Processes
Anti-Bacterial Agents
Bacitracin
Cefazolin
Cephalexin
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents
Anti-Infective Agents, Local

ClinicalTrials.gov processed this record on July 29, 2014