Skip to main content
OpenTrials
Completed

NCT Number: NCT01587937

Hospital Wide Roll-Out of Antimicrobial Stewardship

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Bacterial Infections Bacterial Infections and Mycoses Clostridium Infections Gram-Positive Bacterial Infections Infections

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Sunnybrook Health Sciences Centre

Toronto, Ontario, M4N 3M5, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics

Other

See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.

Primary outcomes

  1. 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

  1. 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)

  2. 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.

  3. 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.

  4. 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)

Sponsors and collaborators

Lead sponsor

Sunnybrook Health Sciences Centre

Other

Collaborators

  • Ontario Ministry of Health and Long Term Care

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2012
Study completion
2012
First posted
Apr 30, 2012
Registry last updated
Nov 19, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.