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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional | Experimental | Preoperative Antibiotics |
|
| Aggressive (Incremental) | Active Comparator | Preoperative antibiotics, antibiotic wash and post operative antibiotics |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Incremental | Drug | Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin |
|
| Measure | Description | Time Frame |
|---|---|---|
| Hospitalization attributed to device infection | Hospitalization attributed to device infection | within one year of device procedure |
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Inclusion Criteria:
> 18 years
received one of the following procedures:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr. Andrew Krahn, M.D | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hamilton General Hospital, McMaster University | Hamilton | Ontario | L8L 2X2 | Canada | ||
| University of Ottawa Heart Institute |
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| ID | Term |
|---|---|
| D001145 | Arrhythmias, Cardiac |
| D007239 | Infections |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D002437 | Cefazolin |
| D014640 | Vancomycin |
| D001414 | Bacitracin |
| D002506 | Cephalexin |
| D002981 | Clindamycin |
| ID | Term |
|---|---|
| D002511 | Cephalosporins |
| D047090 | beta-Lactams |
| D007769 | Lactams |
| D000577 | Amides |
| D009930 |
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| Cefazolin | Drug | Preoperative antibiotic |
|
| Ottawa |
| Ontario |
| K1Y 4W7 |
| Canada |
| Organic Chemicals |
| D013843 | Thiazines |
| D013457 | Sulfur Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D006020 | Glycopeptides |
| D006001 | Glycoconjugates |
| D002241 | Carbohydrates |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D010456 | Peptides, Cyclic |
| D047028 | Macrocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D008034 | Lincomycin |
| D055231 | Lincosamides |
| D011759 | Pyrrolidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006027 | Glycosides |