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Trial record 1 of 1 for:    NCT01002911
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Prevention of Arrhythmia Device Infection Trial (PADIT Pilot) (PADIT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01002911
Recruitment Status : Completed
First Posted : October 28, 2009
Last Update Posted : May 16, 2013
Sponsor:
Information provided by (Responsible Party):
Population Health Research Institute

Tracking Information
First Submitted Date  ICMJE October 27, 2009
First Posted Date  ICMJE October 28, 2009
Last Update Posted Date May 16, 2013
Study Start Date  ICMJE December 2009
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 27, 2009)
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. ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01002911 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 27, 2009)
  • 1. Any treatment with antibiotics for suspected device infection. [ Time Frame: Patients will have one follow-up visit at 12 months ]
  • 2. Antibiotic therapy related adverse event. [ Time Frame: Patients will have one follow-up visit at 12 months ]
  • 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 ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)
Official Title  ICMJE Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Arrythmias
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 27, 2009)
500
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE January 2012
Actual Primary Completion Date January 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01002911
Other Study ID Numbers  ICMJE PADIT
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Population Health Research Institute
Study Sponsor  ICMJE Population Health Research Institute
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Dr. Andrew Krahn University of British Columbia
PRS Account Population Health Research Institute
Verification Date May 2013

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