A Randomized Antimicrobial Stewardship Trial in a Hospital Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,312
- 试验地点
- 2
- 主要终点
- Change and trends in days of antibiotic therapy (DOT)/100 patient days
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Masking for care providers and investigators is not feasible. Outcomes assessors will be blinded to study period and intervention arms when evaluating appropriateness of prescribing.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Randomization to intervention arms is performed on ward level.
- •Eligibility criteria:
- •Surgical or medical wards
- •Patient level (too be included in the outcome analyses)
- •Inclusion Criteria:
- •At least 18 years of age
- •Ongoing antimicrobial therapy on a study ward
- •Signed informed consent
排除标准
- •Patients in palliative care with very short life expectancy
- •Patients from another county than study site
结局指标
主要结局
Change and trends in days of antibiotic therapy (DOT)/100 patient days
时间窗: 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.
次要结局
- 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)
研究者
Thomas Tängdén
Associate professor
Uppsala University