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Hospital Wide Roll-Out of Antimicrobial Stewardship

This study is currently recruiting participants.
Verified April 2012 by Sunnybrook Health Sciences Centre
Sponsor:
Collaborator:
Ontario Ministry of Health and Long Term Care
Information provided by (Responsible Party):
Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier:
NCT01587937
First received: April 13, 2012
Last updated: April 26, 2012
Last verified: April 2012
History of Changes
  Purpose

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.


Condition Intervention
Bacterial Infections
 Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Sunnybrook Health Sciences Centre:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    • 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 Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]
    -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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: No ]

Estimated Enrollment: 20000
Study Start Date: May 2010
Estimated Study Completion Date: April 2012
Estimated Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Antibiotic stewardship intervention
Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial
 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.
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.

  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01587937

Contacts
Contact: Nick Daneman, MD, MSc, FRCPC 416-480-6100 ext 2791 nick.daneman@sunnybrook.ca

Locations
Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Ontario Ministry of Health and Long Term Care
Investigators
Principal Investigator: Nick Daneman Sunnybrook Health Sciences Centre
  More Information

Publications:

Responsible Party: Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT01587937     History of Changes
Other Study ID Numbers: 416-2009
Study First Received: April 13, 2012
Last Updated: April 26, 2012
Health Authority: Canada: Ethics Review Committee

Keywords provided by Sunnybrook Health Sciences Centre:
Antibiotic stewardship.
Clostridium difficile infection.
Antibiotic resistance.

Additional relevant MeSH terms:
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013