NCT01628666|CompletedPhase 4DMC
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Sponsor study identifier
interventional
12,814
1 country
1
Study Start
December 2012
Actual (reported)Primary Completion
September 8, 2017
Actual (reported)Study Completion
September 8, 2017
Actual (reported)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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
September 8, 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 4, 2012
Actual (reported)June 27, 2012
Actual (reported)December 2012
Actual (reported)September 8, 2017
Actual (reported)September 8, 2017
Actual (reported)Hospitalization attributed to device infection
Evaluation is one year post patient's procedure
1. Proven device infection not requiring surgical intervention (medically treated device infection).
Up to one year post procedure
2. Any treatment with antibiotics for suspected device infection.
Up to one year post procedure
3. Antibiotic-related adverse events including culture or antigen proven C. difficile infection.
Up to one year post procedure
4. Prolongation of hospitalization due to proven or suspected adverse events from the antibiotic therapy.
Up to one year post procedure
Cost benefit analysis
At completion of data collection period
Preoperative Antibiotics: Cefazolin preoperative, vancomycin in penicillin allergic patients.
Preoperative antibiotics (Cefazolin and Vancomycin) Bacitracin pocket wash and 2 days of oral Cefalexin post operative.
Single dose of Cefazolin and Vancomycin preoperatively, bacitracin wash and cefalexin post operative.
Coordinating Centre: Population Health Research Institute
Hamilton, Ontario, L8L 2X2, Canada
Andrew Krahn, MD
University of British Columbia
12,814 participants (actual enrollment reported by the registry).
First Submitted
June 4, 2012
First Posted
June 27, 2012
Study Start
December 2012
Actual (reported)Primary Completion
Serum and Tissue Cefazolin Concentrations in Normal Weight Patients Undergoing Cesarean Delivery.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
September 8, 2017
Actual (reported)Study Completion
September 8, 2017
Actual (reported)Last Updated
June 24, 2019
Record last verified: 2019-06
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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