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Completed

NCT Number: NCT01002911

Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

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.

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Key information

Conditions

Arrythmias

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Institut universitaire de cardiologie et de pneumologie de Quebec

Ste-Foy, Quebec, G1V 4G5, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cefazolin, Bacitracin, Cefalexin

Drug

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

Drug

Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Acronym: PADIT

Important dates

Study start
2009
Primary completion
2012
Study completion
2012
First posted
Oct 28, 2009
Registry last updated
May 16, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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