completed

The objective of the PADIT Pilot study was 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 were 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 had a follow up 12 months post-implant to determine if they met the primary outcome for hospitalization for device infection.

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; and cost-benefit analysis.

Co-Principal Investigator on this study was Andrew Krahn, Professor, Head of Division of Cardiology, Department of Medicine, University of British Columbia.

Study Type

Interventional - Drug

Study Design

Randomized pilot

NO. of Countries

1

NO. of Sites

11

NO. of Participants

500

Study Period

2009-2010

Sponsor

PHRI

Canadian Institutes of Health Research (CIHR)

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