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Prevention of Arrhythmia Device Infection Trial (PADIT Pilot) (PADIT)
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Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Arrythmias | Drug: Cefazolin, Bacitracin, Cefalexin Drug: Cefazolin | Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized 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. ]
- 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 ]
| Enrollment: | 500 |
| Study Start Date: | December 2009 |
| Study Completion Date: | January 2012 |
| Primary Completion Date: | January 2012 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
|
Drug: Cefazolin
Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Contacts and LocationsPlease refer to this study by its ClinicalTrials.gov identifier: NCT01002911
| Canada, Quebec | |
| Institut universitaire de cardiologie et de pneumologie de Quebec | |
| Ste-Foy, Quebec, Canada, G1V 4G5 | |
| Principal Investigator: | Dr. Andrew Krahn | University of British Columbia |
More Information
| Responsible Party: | Population Health Research Institute |
| ClinicalTrials.gov Identifier: | NCT01002911 History of Changes |
| Other Study ID Numbers: |
PADIT |
| Study First Received: | October 27, 2009 |
| Last Updated: | May 14, 2013 |
Keywords provided by Population Health Research Institute:
|
Device procedure pacemaker ICD antibiotics |
Additional relevant MeSH terms:
|
Anti-Bacterial Agents Bacitracin Cefazolin Cephalexin |
Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents Anti-Infective Agents, Local |
ClinicalTrials.gov processed this record on June 23, 2017