ArrhythmiaPhase 4NCT01628666
Prevention of Arrhythmia Device Infection Trial (PADIT)
A Phase 4 study testing Incremental and Conventional in people with Arrhythmia, run by Population Health Research Institute at 1 site in Canada.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Arrhythmia
- What is being tested?
- Incremental and Conventional
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12,814 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2012to 8 Sep 2017
- Phase
- Phase 4
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Canada1 site
Coordinating Centre: Population Health Research Institute
Hamilton, Ontario, L8L 2X2
About this study
Official title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
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.
Read the detailed description
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).
- Conditions
- Arrhythmia
- Being tested
- Incremental, Conventional
- Keywords
- Arrhythmia, Device Procedure, Antibiotics, Infection, Cluster
- Medical subject headings
- Arrhythmias, Cardiac, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IncrementalDrug
Also called Cefazolin, Vancomycin, Bacitracin, Cefalexin
Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
ConventionalDrug
Also called Cefazolin
Cefazolin preoperative
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Experimental | Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients. Receives: Drug: Conventional |
| Incremental | Experimental | Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative. Receives: Drug: Incremental |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospitalization attributed to device infection
Measured: Evaluation is one year post patient's procedure
Secondary outcomes (6)
1. Proven device infection not requiring surgical intervention (medically treated device infection).
Measured: Up to one year post procedure
2. Any treatment with antibiotics for suspected device infection.
Measured: Up to one year post procedure
3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.
Measured: Up to one year post procedure
4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.
Measured: Up to one year post procedure
Cost benefit analysis
Measured: At completion of data collection period
6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).
Measured: Up to one year post procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jun 2012 (estimated)
- Study startDec 2012
- Primary completion8 Sep 2017
- Study completion8 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ArrhythmiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 12,814 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Andrew Krahn, MD, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01628666
- Sponsor's protocol ID
- PADIT Cluster Crossover Study
- Status last verified
- Jun 2019
- First submitted
- 4 Jun 2012
- Last updated
- 24 Jun 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Study
- ClinicalTrials.gov ID
- NCT01628666
- Acronym / sponsor ID
- PADIT Cluster Crossover Study
- Conditions
- Arrhythmia
- Keywords
- Arrhythmia, Device Procedure, Antibiotics, Infection, Cluster
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 12,814 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Dec 2012 (actual)
- Primary completion
- 8 Sep 2017 (actual)
- Study completion
- 8 Sep 2017 (actual)
- First posted
- 27 Jun 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Experimental | Drug: ConventionalPreoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients. |
| Incremental | Experimental | Drug: IncrementalPreoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Age >= 18 years
- Received one of the following procedures:
- ICD, pacemaker, CRT-P, CRT-D generator and/or lead replacement
- Patient is not known to have device infection at the time of the surgery
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| IncrementalAlso: Cefazolin, Vancomycin, Bacitracin, CefalexinSingle dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative. | Drug | Incremental |
| ConventionalAlso: CefazolinCefazolin preoperative | Drug | Conventional |
Primary outcome
Hospitalization attributed to device infection
Time frame: Evaluation is one year post patient's procedure
6 secondary outcomes
1. Proven device infection not requiring surgical intervention (medically treated device infection).
Time frame: Up to one year post procedure
2. Any treatment with antibiotics for suspected device infection.
Time frame: Up to one year post procedure
3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.
Time frame: Up to one year post procedure
4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.
Time frame: Up to one year post procedure
Cost benefit analysis
Time frame: At completion of data collection period
6. Rate of device/lead extraction 12 months post patient's procedure (regardless of the cause).
Time frame: Up to one year post procedure
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jun 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Andrew Krahn, MD principal investigator
University of British Columbia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Incremental and Conventional in people with Arrhythmia, 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 8 inclusion and 0 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 24 Jun 2019. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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: Evaluation is one year post patient's procedure). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 24 Jun 2019.