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Research

Photo for PADIT PILOT

PADIT PILOT

Official Title

Prevention of Arrhythmia Device Infection Trial

Status

Completed

Overview

To compare a conventional antibiotic therapy approach to an aggressive antibiotic therapy for the prevention of hospitalization for device infection in high-risk patients undergoing arrhythmia device procedures. Eligible and consenting patients will be randomized to conventional (pre-op antibiotics) or aggressive antibiotics (pre-op, intra-op and post-op) for the prevention of infection prior to the planned device procedure. Patients will have a follow up 12 months post-implant to determine if they met the primary outcome for hospitalization for device infection.

Study Design

Randomized, Pilot Study.

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

Number of Patients

500

Number of Sites

11

Number of Countries

1

Study Period

2009–2010

Principal Investigator

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

Program Manager

Ellison Themeles

Research Coordinator

Kim Simek

Collaborators

CANNECTIN