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Completed

NCT Number: NCT01613092

Prevention of Arrhythmia Device Infection Trial (PADIT)

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).

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Key information

Conditions

Arrhythmia Arrhythmias, Cardiac Cardiovascular Diseases Heart Diseases Infections Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hamilton General Hospital, McMaster University, Hamilton, Ontario, Canada

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About this study

Multi-center, cluster crossover, unblinded, pilot study. Centers will be randomized to conventional vs. incremental antibiotic therapy for 2 months or until eligible 20 patients are treated, whichever comes first. At 2 months, centers will have a crossover period of 4 weeks where the alternate strategy is implemented, followed by the final 2-month/20 patient enrolment period. During each treatment period the randomized antibiotic strategy will be used on all center patients undergoing a device implant procedure. Prior to the planned surgery or at the first follow up visit, patients who meet the study eligibility criteria will be approached to obtain consent for data collection purposes. Follow up will be according to usual clinical care at the center.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • > 18 years
  • received one of the following procedures:
  • a second or subsequent procedure on the arrhythmia device pocket: i. ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement. ii. pocket or lead revision iii. system upgrade (insertion or attempted insertion of leads)
  • new cardiac resynchronization therapy device implant (pacemaker or ICD)

Exclusion criteria

  • life expectancy < 12 months in the opinion of the local investigator.
  • allergy or unable to tolerate cefazolin or clindamycin or vancomycin.
  • allergy or unable to tolerate intracavitary bacitracin identified per-operatively.
  • pre-operative identification that the patient has infection.

Treatment and study plan

Incremental

Drug

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

Other names: Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin

Cefazolin

Drug

Preoperative antibiotic

Primary outcomes

  1. Hospitalization attributed to device infection

    Time frame: within one year of device procedure

    Hospitalization attributed to device infection

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2013
First posted
Jun 6, 2012
Registry last updated
Oct 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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