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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01002911
Other study ID # PADIT
Secondary ID
Status Completed
Phase Phase 3
First received October 27, 2009
Last updated May 14, 2013
Start date December 2009
Est. completion date January 2012

Study information

Verified date May 2013
Source Population Health Research Institute
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 500
Est. completion date January 2012
Est. primary completion date January 2012
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
Canada Institut universitaire de cardiologie et de pneumologie de Quebec Ste-Foy Quebec

Sponsors (1)

Lead Sponsor Collaborator
Population Health Research Institute

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Hospitalization attributed to device infection. Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur. No
Secondary 1. Any treatment with antibiotics for suspected device infection. Patients will have one follow-up visit at 12 months No
Secondary 2. Antibiotic therapy related adverse event. Patients will have one follow-up visit at 12 months No
Secondary 3. Prolongation of hospitalization due to proven or suspected adverse events from the hospitalization. Patients will have one follow-up visit at 12 months No
See also
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