A Randomized Antimicrobial Stewardship Trial in a Hospital Setting
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Infectious Disease
- Sponsor
- Uppsala University
- Enrollment
- 1312
- Locations
- 2
- Primary Endpoint
- Change and trends in days of antibiotic therapy (DOT)/100 patient days
- Status
- Completed
- Last Updated
- 3 years ago
Overview
Brief Summary
The emerging crisis of multidrug-resistant bacteria is accelerated by a massive overuse and misuse of antibiotics. It has been estimated that 50% of antibiotic prescriptions are inappropriate. Antibiotic interventions to improve prescribing patterns have been successfully implemented in primary care in Sweden and other countries. However, much of the last-resort antibiotics are used in hospitals in which decisions on therapy for bacterial infections are more complex. In this project we will explore the appropriateness of antibiotic prescribing in a hospital setting and measures to improve the quality of antimicrobial therapy. Antimicrobial stewardship interventions will be conducted at selected hospital departments using prospective audit and feedback in a multifaceted and cross-disciplinary approach. The intervention effects on antibiotic consumption, appropriateness of prescriptions, patient outcome and emergence of resistance will be evaluated, and a financial cost-effectiveness analysis will be performed.
Detailed Description
Background: In this project we will address the issue of inappropriate antibiotic prescribing in a hospital setting using a systematic and cross-disciplinary approach. We believe that a substantial reduction in antibiotic use and a significant improvement in prescribing patterns can be achieved, which will benefit the patients by reducing the risks of side effects such as antibiotic-induced Clostridium difficile enteritis. Aim: The aim of this study is to implement and evaluate antibiotic interventions at targeted hospital wards. Method: Hospital wards will be randomised to one of two antimicrobial stewardship intervention arms stratified by specialty (medicine or surgery). Prospective audit and feedback is a core intervention strategy in both arms. Statistics: Interrupted time-series analysis (ITS) will be used for the primary endpoint; volume of antimicrobial prescribing. Monthly baseline data at least five years prior to start of the intervention and a during a follow-up period of at least 12 months after end of the intervention period will be used to assess immediate and sustained effects. Endpoints and outcomes: * Primary endpoint is reduction in antibiotic use, days of antibiotic therapy (DOTs)/100 patient days * Secondary endpoints include outcome measures for quantity of antibiotic use, appropriateness of prescriptions, clinical and microbiological outcome and cost-effectiveness. Data on antibiotic use and trends in prescriptions of key antibiotics will be obtained from hospital pharmacies. Data on duration of hospitalization, patient mortality, re-admissions and side effects including antibiotic-associated Clostridium difficile enteritis will be extracted from the medical records to assess potential impact on patient outcome caused by the intervention. Data on emergence of resistance during therapy and general trends in resistance epidemiology will be recorded. The outcome assessment will include a survey to participating physicians on the value different aspects of the stewardship intervention in their daily care of patients with infections. A cost-effectiveness analysis of the intervention will be performed.
Investigators
Thomas Tängdén
Associate professor
Uppsala University
Eligibility Criteria
Inclusion Criteria
- •At least 18 years of age
- •Ongoing antimicrobial therapy on a study ward
- •Signed informed consent
Exclusion Criteria
- •Patients in palliative care with very short life expectancy
- •Patients from another county than study site
Outcomes
Primary Outcomes
Change and trends in days of antibiotic therapy (DOT)/100 patient days
Time Frame: 7 years
Monthly DOT of antibiotics per 100 patient days on ward level assessed 5 y pre-intervention and 1 y post-intervention. Data will be analysed using interrupted time series analysis to assess immediate changes following implementation and comparison of trends before and after the intervention.
Secondary Outcomes
- Intensive Care Unit (ICU) transfer(12 months)
- Appropriate diagnostic examinations(12 months)
- Dose adjustment for renal function within 48 h after initiation of antimicrobial therapy at admission(12 months)
- Therapeutic drug monitoring (TDM)(12 months)
- Drug-drug interactions (DDI)(12 months)
- Costs of administered antimicrobials(12 months)
- Costs of the intervention(12 months)
- Treatment duration (Days per treatment period overall)(12 months)
- In-hospital mortality(12 months)
- Hospital length of stay (LOS)(12 months)
- Intravenous to oral switch(12 months)
- Dose adjustment for renal function when initiating antimicrobial therapy in a non-acute situation(12 months)
- Days of defined daily doses (DDDs)/100 patient days(12 months)
- 30-d mortality(12 months)
- Hospital readmission within 30 d after discharge(12 months)
- Hospital readmission due to relapse of infection within 30 d after discharge(12 months)
- Guideline compliance(12 months)
- De-escalation or shift to targeted therapy(12 months)
- Incidence of multidrug-resistant organisms (MDRO)(12 months)
- Incidence of Clostridium difficile infections (CDI)(12 months)