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Research

Photo for PADIT Cluster Crossover

PADIT Cluster Crossover

Official Title

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

Status

Ongoing

Overview

To reduce infection after pacemaker or ICD surgery, antibiotics are used but the ideal amount and duration is unknown. Many different antibiotic strategies are used in Canada but no comparative effectiveness studies have been performed. We do not know if the standard single dose of intravenous antibiotic is enough or if extra doses of different antibiotics before, during and after surgery help to reduce infection. Pacemaker and ICD procedures are delivered at high volume specialized centres following Standard Operating Procedures. Because of this systemization of care, comparative effectiveness testing to improve care should be tested in the systems in which they will be used. PADIT will test whether single antibiotics or additional antibiotics reduce infection best by randomizing centres, not patients, to one antibiotic strategy or another. 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 a final time at 18 months. All patients at the centre receiving a pacemaker of ICD will receive that strategy during the study. One year post implant sites will review their hospital records to determine if any endpoints were met.

Study Design

Randomized, Cluster Crossover.

Primary Endpoint

Hospitalization attributed to device infection, device infection not requiring surgical intervention, treatment with antibiotics for suspected device infection, antibiotic related adverse events, prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy, cost benefit analysis, rate of device/lead extraction 12 months post procedure

Number of Patients

10800

Number of Sites

40

Number of Countries

3

Study Period

2012–2017

Principal Investigator

Andrew Krahn (PI) and Stuart Connolly (Steering Committee Chair)

Program Manager

Kimberly Begley

Research Coordinator

Kim Simek