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

October 27, 2009
May 14, 2013
December 2009
January 2012   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01002911 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)
Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection

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.

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.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Arrythmias
  • 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
  • Drug: Cefazolin
    Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision
  • Experimental: Aggressive Antibiotic therapy
    Patients receive preoperative intravenous antibiotics, intracavitary antibiotics during surgery and postoperative antibiotics.
    Intervention: Drug: Cefazolin, Bacitracin, Cefalexin
  • Active Comparator: Conventional Antibiotic Therapy
    Preoperative intravenous antibiotics
    Intervention: Drug: Cefazolin
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
500
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01002911
PADIT
Yes
Population Health Research Institute
Population Health Research Institute
Not Provided
Principal Investigator: Dr. Andrew Krahn University of British Columbia
Population Health Research Institute
May 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP