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Hospital Wide Roll-Out of Antimicrobial Stewardship

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01587937
Enrollment
19220
Registered
2012-04-30
Start date
2010-04-30
Completion date
2012-04-30
Last updated
2014-11-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bacterial Infections

Keywords

Antibiotic stewardship., Clostridium difficile infection., Antibiotic resistance.

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.

Interventions

OTHERAntibiotic 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.

Sponsors

Ontario Ministry of Health and Long Term Care
CollaboratorOTHER_GOV
Sunnybrook Health Sciences Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Healthy volunteers
No

Inclusion 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

Design outcomes

Primary

MeasureTime frameDescription
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)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

MeasureTime frameDescription
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)-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 daypatients 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.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 isolatespatients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026