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Prevention of Arrhythmia Device Infection Trial (PADIT)

NCT01613092 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 241

Last updated 2014-10-10

No results posted yet for this study

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

Interventions

DRUG

Incremental

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

DRUG

Cefazolin

Preoperative antibiotic

Sponsors & Collaborators

  • Population Health Research Institute

    lead OTHER

Principal Investigators

  • Dr. Andrew Krahn, M.D · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-05-31
Primary Completion
2013-11-30
Completion
2013-12-31

Countries

  • Canada

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01613092 on ClinicalTrials.gov