Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

NCT01002911 | Completed Phase 3 DMC

• 1 other identifier: PADIT
• Study Type: interventional
• Target: 500
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Arrythmias

Keywords

Device procedure; pacemaker; ICD; antibiotics

Outcome Measures

Primary Outcomes (1)

• Hospitalization attributed to device infection.

  Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur.

Secondary Outcomes (3)

• 1. Any treatment with antibiotics for suspected device infection.

  Patients will have one follow-up visit at 12 months

• 2. Antibiotic therapy related adverse event.

  Patients will have one follow-up visit at 12 months

• 3. Prolongation of hospitalization due to proven or suspected adverse events from the hospitalization.

  Patients will have one follow-up visit at 12 months

Study Arms (2)

Aggressive Antibiotic therapy

EXPERIMENTAL

Patients receive preoperative intravenous antibiotics, intracavitary antibiotics during surgery and postoperative antibiotics.

Drug: Cefazolin, Bacitracin, Cefalexin

Conventional Antibiotic Therapy

ACTIVE COMPARATOR

Preoperative intravenous antibiotics

Drug: Cefazolin

Interventions

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

Aggressive Antibiotic therapy

Cefazolin DRUG

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

Conventional Antibiotic Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (1)

Institut universitaire de cardiologie et de pneumologie de Quebec

Ste-Foy, Quebec, G1V 4G5, Canada

Location

Related Publications (3)

• Longtin Y, Gervais P, Birnie DH, Wang J, Alings M, Philippon F, Parkash R, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Redfearn D, Toal S, Becker G, Degrace M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Rioux L, Hemels MEW, Bouwels LHR, Exner DV, Dorian P, Connolly SJ, Krahn AD. Impact of Choice of Prophylaxis on the Microbiology of Cardiac Implantable Electronic Device Infections: Insights From the Prevention of Arrhythmia Device Infection Trial (PADIT). Open Forum Infect Dis. 2021 Oct 14;8(11):ofab513. doi: 10.1093/ofid/ofab513. eCollection 2021 Nov.

  PMID: 34859113 DERIVED

• Birnie DH, Wang J, Alings M, Philippon F, Parkash R, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Redfearn D, Toal S, Becker G, Degrace M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Gervais P, Rioux L, Hemels MEW, Bouwels LHR, Exner DV, Dorian P, Connolly SJ, Longtin Y, Krahn AD. Risk Factors for Infections Involving Cardiac Implanted Electronic Devices. J Am Coll Cardiol. 2019 Dec 10;74(23):2845-2854. doi: 10.1016/j.jacc.2019.09.060.

  PMID: 31806127 DERIVED

• Krahn AD, Longtin Y, Philippon F, Birnie DH, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Redfearn D, Toal S, Becker G, Degrace M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Gervais P, Rioux L, Hemels MEW, Bouwels LHR, van Vlies B, Wang J, Exner DV, Dorian P, Parkash R, Alings M, Connolly SJ. Prevention of Arrhythmia Device Infection Trial: The PADIT Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3098-3109. doi: 10.1016/j.jacc.2018.09.068.

  PMID: 30545448 DERIVED

MeSH Terms

Interventions

Cefazolin; Bacitracin; Cephalexin

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Dr. Andrew Krahn

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2009
• First Posted: October 28, 2009
• Study Start: December 1, 2009
• Primary Completion: January 1, 2012
• Study Completion: January 1, 2012
• Last Updated: May 16, 2013

Record last verified: 2013-05

Locations

CA (1)