A Phase 4 interventional study of Incremental and Cefazolin in Arrhythmia, sponsored by Population Health Research Institute. Completed at 2 sites in Canada. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2014-10-10.
Sponsored by Population Health Research Institute · Phase 4, Interventional, and Prevention
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 241 is above the median of 120 across 4,200 interventional studies indexed under Infections.
Browse Infections studies →Population Health Research Institute is the lead sponsor of 114 studies on the registry; 27 are open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
Counted across the registry records on this site, refreshed daily.
received one of the following procedures:
Exclusion Criteria:
Preoperative Antibiotics
Drug: Cefazolin
Preoperative antibiotics, antibiotic wash and post operative antibiotics
Drug: Incremental
Cefazolin and Vancomycin pre-op, bacitracin wash and postoperative cefalexin or clindamycin
Also known as: Cefazolin , Vancomycin, bacitracin, cefalexin or clindamycin
Preoperative antibiotic
Hospitalization attributed to device infection
Hospitalization attributed to device infection
Time frame: within one year of device procedure
This study is completed, as verified in Oct 2014. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Population Health Research Institute