Prevention of Arrhythmia Device Infection Trial (PADIT)

NCT01613092 | Completed Phase 4 DMC

• 1 other identifier: PADIT Cluster Crossover Pilot
• Study Type: interventional
• Target: 241
• Locations: 1 country
• Sites: 2

Brief Summary

The goal of the pilot study is to compare whether a centre-wide policy of incremental antibiotic therapy will reduce pacemaker infection compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. This pilot study will provide feasibility information for a larger cluster randomized crossover design (CRCD).

Conditions

Arrhythmia

Keywords

Arrhythmia; Device Procedure; High risk patients; Antibiotics; Infection; Cluster

Outcome Measures

Primary Outcomes (1)

• Hospitalization attributed to device infection

  Hospitalization attributed to device infection

  within one year of device procedure

Study Arms (2)

Conventional

EXPERIMENTAL

Preoperative Antibiotics

Drug: Cefazolin

Aggressive (Incremental)

ACTIVE COMPARATOR

Preoperative antibiotics, antibiotic wash and post operative antibiotics

Drug: Incremental

Interventions

Incremental DRUG

Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin

Also known as: Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin

Aggressive (Incremental)

Cefazolin DRUG

Preoperative antibiotic

Conventional

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \> 18 years
• received one of the following procedures:
• a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)
• new cardiac resynchronization therapy device implant (pacemaker or ICD)

You may not qualify if:

• life expectancy \< 12 months in the opinion of the local investigator.
• allergy or unable to tolerate cefazolin or clindamycin or vancomycin.
• allergy or unable to tolerate intracavitary bacitracin identified per-operatively.
• pre-operative identification that the patient has infection.

Sponsors & Collaborators

• Population Health Research Institute: lead

Study Sites (2)

Hamilton General Hospital, McMaster University

Hamilton, Ontario, L8L 2X2, Canada

Location

University of Ottawa Heart Institute

Ottawa, Ontario, K1Y 4W7, Canada

Location

MeSH Terms

Conditions

Arrhythmias, Cardiac; Infections

Interventions

Cefazolin; Vancomycin; Bacitracin; Cephalexin; Clindamycin

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Cephalosporins; beta-Lactams; Lactams; Amides; Organic Chemicals; Thiazines; Sulfur Compounds; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Peptides, Cyclic; Macrocyclic Compounds; Polycyclic Compounds; Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Glycosides

Study Officials

• Dr. Andrew Krahn, M.D

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 4, 2012
• First Posted: June 6, 2012
• Study Start: May 1, 2011
• Primary Completion: November 1, 2013
• Study Completion: December 1, 2013
• Last Updated: October 10, 2014

Record last verified: 2014-10

Locations

CA (2)