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Research

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PADIT Cluster Crossover Pilot

Official Title

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

Status

Completed

Overview

To compare whether a centre-wide policy of incremental antibiotic therapy will reduce hospitalization for device 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.

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

Number of Patients

240

Number of Sites

6

Number of Countries

1

Study Period

2010–2012

Principal Investigator

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

Program Manager

Ellison Themeles

Research Coordinator

Kim Simek

Collaborators

CANNECTIN