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Completed

NCT Number: NCT01628666

Prevention of Arrhythmia Device Infection Trial (PADIT)

The goal of the study is to compare whether a center-wide policy of incremental antibiotic therapy will reduce CIED infection rate compared to a policy of conventional antibiotic prophylaxis in high-risk patients undergoing arrhythmia device procedures. All antibiotics used are approved for use and readily available.

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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

Coordinating Centre: Population Health Research Institute

Hamilton, Ontario, L8L 2X2, Canada

About this study

This is a randomized prospective cluster crossover trial to track outcomes of high infection risk patients undergoing arrhythmia device procedures. Centres will be randomized to either conventional antibiotic therapy or incremental antibiotic therapy. Patients will not be randomized. 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 the final time at 18 months. During each treatment period the randomized antibiotic therapy will be used on all centre patients undergoing a device implant procedure.

Ethics approval has been obtained in all sites for waiver of consent with notification of the study (i.e. data collection is taking place to track infection rates). A third of sites obtain consent after the procedure for collection of data (but not for care, since either arm is the standard of care).

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Age >= 18 years
  • Received one of the following procedures:
  • A second or subsequent procedure on the arrhythmia device pocket:

ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement

  • Pocket or lead revision
  • System upgrade (insertion or attempted insertion of leads)
  • New cardiac resynchronization therapy device implant (pacemaker or ICD)
  • Patient is not known to have device infection at the time of the surgery

Treatment and study plan

Incremental

Drug

Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.

Other names: Cefazolin, Vancomycin, Bacitracin, Cefalexin

conventional

Drug

Cefazolin preoperative

Other names: Cefazolin

Primary outcomes

  1. Hospitalization attributed to device infection

    Time frame: Evaluation is one year post patient's procedure

Secondary outcomes

  1. 1. Proven device infection not requiring surgical intervention (medically treated device infection).

    Time frame: Up to one year post procedure

  2. 2. Any treatment with antibiotics for suspected device infection.

    Time frame: Up to one year post procedure

  3. 3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.

    Time frame: Up to one year post procedure

  4. 4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.

    Time frame: Up to one year post procedure

  5. Cost benefit analysis

    Time frame: At completion of data collection period

  6. 6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).

    Time frame: Up to one year post procedure

Sponsors and collaborators

Lead sponsor

Population Health Research Institute

Other

Collaborators

  • Canadian Institutes of Health Research (CIHR)

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2017
Study completion
2017
First posted
Jun 27, 2012
Registry last updated
Jun 24, 2019

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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