Prevention of Arrhythmia Device Infection Trial (PADIT)

Arrhythmia Clinical Trial

Official title:

Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01628666
• Other study ID #: PADIT Cluster Crossover Study
• Status: Completed
• Phase: Phase 4
• Start date: December 2012
• Est. completion date: September 8, 2017

Study information

• Verified date: June 2019
• Source: Population Health Research Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.

Description:

This is a randomized prospective cluster crossover trial to track outcomes of high infection risk patients undergoing arrhythmia device procedures. Centres will be randomized to either conventional antibiotic therapy or incremental antibiotic therapy. Patients will not be randomized. Centres will be randomized to one therapy and then cross over to the next after 6 months. At one year they will randomize again and then cross over for the final time at 18 months. During each treatment period the randomized antibiotic therapy will be used on all centre patients undergoing a device implant procedure.

Ethics approval has been obtained in all sites for waiver of consent with notification of the study (i.e. data collection is taking place to track infection rates). A third of sites obtain consent after the procedure for collection of data (but not for care, since either arm is the standard of care).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12814
• Est. completion date: September 8, 2017
• Est. primary completion date: September 8, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age >= 18 years

2. Received one of the following procedures:

1. A second or subsequent procedure on the arrhythmia device pocket:

ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement

2. Pocket or lead revision

3. System upgrade (insertion or attempted insertion of leads)

4. New cardiac resynchronization therapy device implant (pacemaker or ICD)

3. Patient is not known to have device infection at the time of the surgery

Related Conditions & MeSH terms

• Arrhythmia
• Infection

Intervention

Drug:
• Incremental
Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
• Conventional
Cefazolin preoperative

Locations

Country	Name	City	State
Canada	Coordinating Centre: Population Health Research Institute	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
Population Health Research Institute	Canadian Institutes of Health Research (CIHR)

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization attributed to device infection		Evaluation is one year post patient's procedure
Secondary	1. Proven device infection not requiring surgical intervention (medically treated device infection).		Up to one year post procedure
Secondary	2. Any treatment with antibiotics for suspected device infection.		Up to one year post procedure
Secondary	3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.		Up to one year post procedure
Secondary	4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.		Up to one year post procedure
Secondary	Cost benefit analysis		At completion of data collection period
Secondary	6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).		Up to one year post procedure