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Clinical Trials/NCT01587937
NCT01587937
Completed
Not Applicable

Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial

Sunnybrook Health Sciences Centre1 site in 1 country19,220 target enrollmentApril 2010

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Bacterial Infections
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
19220
Locations
1
Primary Endpoint
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
Status
Completed
Last Updated
11 years ago

Overview

Brief Summary

Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has published guidelines stating that all hospitals should develop an institutional program to enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic stewardship audit-and-feedback intervention for all patients reaching their third or tenth day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The investigators hypothesize that this intervention will result in similar benefits outside of the intensive care unit, and so expanded the intervention to non-ICU medical and surgical wards. To increase the rigor of our program evaluation, the roll-out was conducted in a stepped-wedge randomized controlled design.

Registry
clinicaltrials.gov
Start Date
April 2010
End Date
April 2012
Last Updated
11 years ago
Study Type
Interventional
Study Design
Crossover
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

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

Outcomes

Primary Outcomes

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)

Secondary Outcomes

  • Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))
  • Antibiotic susceptibility of gram negative bacterial isolates(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))
  • Hospital-acquired Clostridium difficile infection.(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))
  • Costs of antibiotic therapy ($) per patient day(patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics))

Study Sites (1)

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