ArrhythmiaPhase 4NCT01613092
Prevention of Arrhythmia Device Infection Trial (PADIT)
A Phase 4 study testing Incremental and Cefazolin in people with Arrhythmia, run by Population Health Research Institute at 2 sites in Canada.
Trial summary
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. 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 Cefazolin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 241 participants
- Where
- 2 sitesCanada
- Study dates
- May 2011to Dec 2013
- 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
- > 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)
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Hamilton General Hospital, McMaster University
Hamilton, Ontario, L8L 2X2
University of Ottawa Heart Institute
Ottawa, Ontario, K1Y 4W7
About this study
Official title: Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study
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).
Read the detailed description
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.
- Conditions
- Arrhythmia
- Being tested
- Incremental, Cefazolin
- Keywords
- Arrhythmia, Device Procedure, High risk patients, 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 or clindamycin
Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin
CefazolinDrug
Preoperative antibiotic
| Study group | Role | What they receive |
|---|---|---|
| Conventional | Experimental | Preoperative Antibiotics Receives: Drug: Cefazolin |
| Aggressive (Incremental) | Active comparator | Preoperative antibiotics, antibiotic wash and post operative antibiotics 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
Hospitalization attributed to device infection
Measured: within one year of device procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2012 (estimated)
- Study startMay 2011
- Primary completionNov 2013
- Study completionDec 2013
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
- 241 participants (actual)
Sponsor and investigators
- Lead sponsor
- Population Health Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dr. Andrew Krahn, M.D, Principal investigator, University of British Columbia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01613092
- Sponsor's protocol ID
- PADIT Cluster Crossover Pilot
- Status last verified
- Oct 2014
- First submitted
- 4 Jun 2012
- Last updated
- 10 Oct 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Arrhythmia Device Infection Trial (PADIT) Cluster Crossover Pilot Study
- ClinicalTrials.gov ID
- NCT01613092
- Acronym / sponsor ID
- PADIT Cluster Crossover Pilot
- Conditions
- Arrhythmia
- Keywords
- Arrhythmia, Device Procedure, High risk patients, Antibiotics, Infection, Cluster
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 241 participants (actual)
- Lead sponsor
- Population Health Research InstituteUniversity, hospital or other
- Study start
- May 2011
- Primary completion
- Nov 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 6 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 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).
Detailed description
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Conventional | Experimental | Drug: CefazolinPreoperative Antibiotics |
| Aggressive (Incremental) | Active comparator | Drug: IncrementalPreoperative antibiotics, antibiotic wash and post operative antibiotics |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- > 18 years
- received one of the following procedures:
Key exclusion criteria (4 listed)
- 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.
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, cefalexin or clindamycinCefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin | Drug | Aggressive (Incremental) |
| CefazolinPreoperative antibiotic | Drug | Conventional |
Primary outcome
Hospitalization attributed to device infection
Time frame: within one year of device procedure
Hospitalization attributed to device infection
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 10 Oct 2014.
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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.
Dr. Andrew Krahn, M.D principal investigator
University of British Columbia
2 sites 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 Cefazolin in people with Arrhythmia, run by Population Health Research Institute at 2 sites 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 4 inclusion and 4 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 10 Oct 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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: within one year of device 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 10 Oct 2014.