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ArrythmiasPhase 3PADITNCT01002911

Prevention of Arrhythmia Device Infection Trial (PADIT Pilot)

A Phase 3 study testing Cefazolin, Bacitracin, Cefalexin and Cefazolin in people with Arrythmias, run by Population Health Research Institute at 1 site in Canada.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk patients undergoing arrhythmia device procedures. All antibiotics are approved for use and readily available. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Arrythmias
What is being tested?
Cefazolin, Bacitracin, Cefalexin and Cefazolin
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
500 participants
Where
1 siteCanada
Study dates
Dec 2009to Jan 2012
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • > 18 years
  • One of the following planned device procedures:
  • ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement or
  • Pocket or lead revision or
  • System upgrade (insertion or attempted insertion of leads) or
  • New cardiac resynchronization therapy device implant (pacemaker or ICD)

Who cannot join

  • Unable or unwilling to provide written informed consent
  • Unable or unwilling to complete the study follow-up schedule
  • Life expectancy < 12 months as per the opinion if the local investigator
  • Allergy to or unable to tolerate cefazolin or clindamycin or vancomycin
  • Allergy to or unable to tolerate intracavitary bacitracin or gentamicin or cefazolin
  • Previously enrolled in this trial
  • In another study that would confound the results of this trial

Trial locations and contacts

1 site in 1 country.

Canada1 site

  • Institut universitaire de cardiologie et de pneumologie de Quebec

    Ste-Foy, Quebec, G1V 4G5

Other trials in Canada

About this study

Official title: Phase III Pilot Study - A Simple Randomized Trial of Conventional Versus Multimodal Prevention of Arrhythmia Device Infection

The goal of the pilot study is to compare conventional antibiotic therapy to an aggressive antibiotic therapy plan for the prevention of arrhythmia device infection in high-risk patients undergoing arrhythmia device procedures. All antibiotics are approved for use and readily available.

Read the detailed description

Infection can occur after surgery for either a pacemaker or an implantable defibrillation and can have very serious consequences. These infections are common and can be seen in as many as 2-3% of high-risk patients. Doctors use antibiotics to prevent these infections, but we do not know how much or how often to give the antibiotics to get the best effect. It is not known whether additional antibiotics during and after the operation would further reduce the risk of infection. This research study will compare two different ways of using common antibiotics to prevent infection during and following a device procedure. One way is the standard approach of a single dose before surgery and the other way uses more antibiotics. We do not know if either way is better. The purpose of this study therefore, is to compare two types of antibiotic therapy plans to better understand if one is most effective in preventing infection.

This study will provide the ability to evaluate the feasibility (i.e. site activation, enrollment, compliance, drop-out) and generate proof of concept for the larger clinical trial of 12,000 patients in all 25 Canadian Hospitals implanting ICDs, which will be submitted to the CIHR. Additionally, the study supports the continued initiatives of the network of physician investigators (Canadian Heart Rhythm Society Device Advisory Committee - CHRS DAC) collaborating to address arrhythmia procedures related clinical trials that will answer simple clinical questions that will focus initially on safety issues.

Conditions
Arrythmias
Being tested
Cefazolin, Bacitracin, Cefalexin, Cefazolin
Keywords
Device procedure, pacemaker, ICD, antibiotics

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cefazolin, Bacitracin, CefalexinDrug

    Single does of Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision, Bacitracin wash, Cefalexin 250-500 mg TID

  • CefazolinDrug

    Cefazolin 1-2 g iv given over 60-120 minutes, 60-120 minutes prior to skin incision

Study groups in NCT01002911
Study groupRoleWhat they receive
Aggressive Antibiotic therapyExperimentalPatients receive preoperative intravenous antibiotics, intracavitary antibiotics during surgery and postoperative antibiotics.
Receives: Drug: Cefazolin, Bacitracin, Cefalexin
Conventional Antibiotic TherapyActive comparatorPreoperative intravenous antibiotics
Receives: Drug: Cefazolin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Hospitalization attributed to device infection.

    Measured: Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur.

Secondary outcomes (3)

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

    Measured: Patients will have one follow-up visit at 12 months

  2. 2. Antibiotic therapy related adverse event.

    Measured: Patients will have one follow-up visit at 12 months

  3. 3. Prolongation of hospitalization due to proven or suspected adverse events from the hospitalization.

    Measured: Patients will have one follow-up visit at 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Oct 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionJan 2012
  4. Study completionJan 2012

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
500 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01002911
Sponsor's protocol ID
PADIT
Acronym
PADIT
Status last verified
May 2013
First submitted
27 Oct 2009
Last updated
16 May 2013
Results posted
No
Data monitoring committee
Yes

Publications

  • Longtin Y, Gervais P, Birnie DH, Wang J, Alings M, Philippon F, Parkash R, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Redfearn D, Toal S, Becker G, Degrace M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Rioux L, Hemels MEW, Bouwels LHR, Exner DV, Dorian P, Connolly SJ, Krahn AD. Impact of Choice of Prophylaxis on the Microbiology of Cardiac Implantable Electronic Device Infections: Insights From the Prevention of Arrhythmia Device Infection Trial (PADIT). Open Forum Infect Dis. 2021 Oct 14;8(11):ofab513. doi: 10.1093/ofid/ofab513. eCollection 2021 Nov.

    PubMed 34859113

  • Birnie DH, Wang J, Alings M, Philippon F, Parkash R, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Redfearn D, Toal S, Becker G, Degrace M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Gervais P, Rioux L, Hemels MEW, Bouwels LHR, Exner DV, Dorian P, Connolly SJ, Longtin Y, Krahn AD. Risk Factors for Infections Involving Cardiac Implanted Electronic Devices. J Am Coll Cardiol. 2019 Dec 10;74(23):2845-2854. doi: 10.1016/j.jacc.2019.09.060.

    PubMed 31806127

  • Krahn AD, Longtin Y, Philippon F, Birnie DH, Manlucu J, Angaran P, Rinne C, Coutu B, Low RA, Essebag V, Morillo C, Redfearn D, Toal S, Becker G, Degrace M, Thibault B, Crystal E, Tung S, LeMaitre J, Sultan O, Bennett M, Bashir J, Ayala-Paredes F, Gervais P, Rioux L, Hemels MEW, Bouwels LHR, van Vlies B, Wang J, Exner DV, Dorian P, Parkash R, Alings M, Connolly SJ. Prevention of Arrhythmia Device Infection Trial: The PADIT Trial. J Am Coll Cardiol. 2018 Dec 18;72(24):3098-3109. doi: 10.1016/j.jacc.2018.09.068.

    PubMed 30545448

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Cefazolin, Bacitracin, Cefalexin and Cefazolin in people with Arrythmias, run by Population Health Research Institute at 1 site in Canada.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 May 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Hospitalization attributed to device infection. (time frame: Patients will have one follow-up visit at 12 months or earlier should a primary outcome event occur.). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01002911, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 May 2013.

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