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.
Drug: Cefazolin, Bacitracin, Cefalexin
|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|
- 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 ]
- 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 ]
|Study Start Date:||December 2009|
|Study Completion Date:||January 2012|
|Primary Completion Date:||January 2012 (Final data collection date for primary outcome measure)|
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
Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision
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.
|Institut universitaire de cardiologie et de pneumologie de Quebec|
|Ste-Foy, Quebec, Canada, G1V 4G5|
|Principal Investigator:||Dr. Andrew Krahn||University of British Columbia|