Hospital Wide Roll-Out of Antimicrobial Stewardship
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ClinicalTrials.gov Identifier: NCT01587937 |
Recruitment Status
:
Completed
First Posted
: April 30, 2012
Last Update Posted
: November 19, 2014
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Condition or disease | Intervention/treatment | Phase |
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Bacterial Infections | Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 19220 participants |
Allocation: | Randomized |
Intervention Model: | Crossover Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Health Services Research |
Official Title: | Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial |
Study Start Date : | April 2010 |
Actual Primary Completion Date : | April 2012 |
Actual Study Completion Date : | April 2012 |
Arm | Intervention/treatment |
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Experimental: Antibiotic stewardship intervention
Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial
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Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics
See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.
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No Intervention: Control
The pre-intervention period will serve as the control period on each medical and surgical service. The cross-over is uni-directional from control to intervention; all services receive the intervention by the end of the study. This is a stepped wedge design. The order of roll-out is randomized.
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- Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs) [ Time Frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) ]
- Targeted broadspectrum antibiotics include third generation cephalosporins (ceftriaxone, ceftazidime), beta-lactam beta-lactamase inhibitors (piperacillin-tazobactam), fluoroquinolones (ciprofloxacin, levofloxacin), carbapenems (ertapenem and meropenem), and glycopeptides (vancomycin)
- DOTs are defined as the number of unique antibiotic agents prescribed each day (regardless of dose)
- Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs) [ Time Frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) ]-Definition as per primary outcome, but can include any antibiotic (not just those broadspectrum agents targeted by the intervention)
- Costs of antibiotic therapy ($) per patient day [ Time Frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) ]Based on acquisition costs for each agent.
- Hospital-acquired Clostridium difficile infection. [ Time Frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) ]Cases of Clostridium difficile infection deemed to have been acquired during the current hospital stay by prospective Infection Prevention & Control surveillance team.
- Antibiotic susceptibility of gram negative bacterial isolates [ Time Frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics) ]

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Ages Eligible for Study: | Child, Adult, Senior |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
All patients admitted to the medical/surgical services will be included in statistical analysis of program evaluation. The inclusion/exclusion criteria below, just define who receives the antibiotic stewardship intervention on each service.
Inclusion Criteria:
- admitted to one of these services: general internal medicine, cardiology, nephrology, orthopedic surgery, neurosurgery, general surgery or trauma surgery
- receiving 3rd or 10th day of treatment with one of the following antibiotics:
- ceftriaxone, ceftazidime, piperacillin-tazobactam, ciprofloxacin, levofloxacin, meropenem, ertapenem, vancomycin
Exclusion Criteria:
- patient being followed by the infectious diseases consult service

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01587937
Canada, Ontario | |
Sunnybrook Health Sciences Centre | |
Toronto, Ontario, Canada, M4N 3M5 |
Principal Investigator: | Nick Daneman | Sunnybrook Health Sciences Centre |
Publications:
Responsible Party: | Sunnybrook Health Sciences Centre |
ClinicalTrials.gov Identifier: | NCT01587937 History of Changes |
Other Study ID Numbers: |
416-2009 |
First Posted: | April 30, 2012 Key Record Dates |
Last Update Posted: | November 19, 2014 |
Last Verified: | November 2014 |
Keywords provided by Sunnybrook Health Sciences Centre:
Antibiotic stewardship. Clostridium difficile infection. Antibiotic resistance. |
Additional relevant MeSH terms:
Bacterial Infections Anti-Bacterial Agents Antibiotics, Antitubercular Anti-Infective Agents Antitubercular Agents |