Epidemiology of Antimicrobial-use and Antimicrobial-resistant Infections in Four Hospitals in Thailand
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 108,000
- 试验地点
- 4
- 主要终点
- New antimicrobial-resistant bloodstream infection
研究概览
简要总结
The main goal of this retrospective observational study is to understand how stepping down antibiotic treatment (called antibiotic de-escalation) affects patients who receive it compared to those who don't after received a short-course (≤7 days) of parenteral antibiotics. The investigators will use past medical records from four public referral hospitals in Thailand from the year 2019 to 2024. The investigators will firstly evaluate which types of patients are more likely to receive antibiotic de-escalation. Then, the investigators will estimate the impact of antibiotic de-escalation, while taking those differences into account. This way, it will help us understand the impact of antibiotic de-escalation in real-world clinical practice. The investigators also aim to assess how accurate automated outbreak detection systems are at detecting outbreaks, evaluate patterns of antimicrobial use and antimicrobial-resistant infections, and develop new indicators for antimicrobial stewardship that are applicable for local and national actions in low and middle-income countries.
详细描述
Rationale:
Despite the availability of guidance documents for implementing antimicrobial stewardship (AMS) programs at both hospital and national levels, there is a lack of robust data to monitor and evaluate the current antimicrobial use practice in low and middle-income countries (LMICs). Evidence on the impact of antibiotic de-escalation on antimicrobial-resistant (AMR) infection is limited. In addition, practical guidelines on how to utilize and analyze routine data for LMICs have not been established.
Objective:
In this study, our primary objective is (a) to evaluate impact of antibiotic de-escalation. Our secondary objectives are (b) to estimate accuracy of automated outbreak detection systems, (c) to evaluate epidemiology of antimicrobial use (AMU) and AMR infections and associations between AMU and AMR infections, and (d) to develop AMS outcome indicators that are applicable for local and national actions in low and middle-income countries (LMICs)
Methodology:
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For primary objectives Inclusion Criteria
- •All age and gender
- •Admitted to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024
- •Received a parenteral antibiotic for at least four consecutive days
- •Were still hospitalized on day 8 after starting a parenteral antibiotic
排除标准
- •Admitted as day admissions to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024
- •Had a clinical specimen collected within 2 calendar days of starting a parenteral antibiotic culture positive for an antimicrobial-resistant organism or Staphylococcus aureus
- •Antimicrobial-resistant (AMR) organism is defined as an organism that is resistant to Access and Low Watch antibiotics, and if the organism is the cause of infection, the recommended antimicrobial therapy involves the use of Medium Watch, High Watch or Reserve antibiotics. The common organisms include methicillin-resistant S. aureus, methicillin-resistant coagulase-negative Staphylococcus spp., ampicillin-resistant Enterococcus spp., vancomycin-resistant Enterococcus spp., 3rd-generation cephalosporin-resistant Gram-negative bacterium and carbapenem-resistant Gram-negative bacterium. The definition of organism includes organisms frequently associated with contamination including coagulase-negative staphylococci, viridans group streptococci, Corynebacterium spp., Bacillus spp., Diptheroid spp., Micrococcus spp. and Propionibacterium spp.. All types of specimens are included (e.g. sputum and tracheal suction). We excluded such patients because the study has no clinical data to differentiate whether the isolated AMR organisms are causing infections or represent colonization.
- •For secondary objectives
- •Inclusion Criteria:
- •All age and gender
- •Admitted to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024
- •Exclusion Criteria:
- •Admitted as day admissions to four collaborating hospitals from 1 Jan 2019 to 31 Dec 2024
研究组 & 干预措施
No antibiotic de-escalation
No antibiotic de-escalation group is defined as patients who are still hospitalized and are receiving a parenteral antibiotic classified as Medium Watch (e.g. Piperacillin-tazobactam), High Watch (e.g. carbapenem) or Reserve (e.g. Tigecycline, Fosfomycin, and Colistin) on day 8 after starting a parenteral antibiotic therapy. Only patients who receive parenteral antibiotics for at least four consecutive days are included as a proxy for presumed severe infection. Day 8 is used as a proxy to represent the day immediately following the end of a short-course (≤7 days) of parenteral antibiotics.
De-escalation by using Access or Low Watch parenteral antibiotics
De-escalation by using Access or Low Watch parenteral antibiotics group is defined as patients who are still hospitalized and are receiving a parenteral antibiotic classified as Access (e.g. ampicillin, gentamicin and amoxicillin-clavulanic acid) or Low Watch (e.g. ceftriaxone) on day 8 after starting a parenteral antibiotic therapy. Only patients who receive parenteral antibiotics for at least four consecutive days are included as a proxy for presumed severe infection. Day 8 is used as a proxy to represent the day immediately following the end of a short-course (≤7 days) of parenteral antibiotics.
De-escalation by cessation of parenteral antibiotics
De-escalation by cessation of parenteral antibiotics group is defined as patients who are still hospitalized and are not receiving any parenteral antibiotics on day 8 after starting a parenteral antibiotic therapy. Only patients who receive parenteral antibiotics for at least four consecutive days are included as a proxy for presumed severe infection. Day 8 is used as a proxy to represent the day immediately following the end of a short-course (≤7 days) of parenteral antibiotics.
结局指标
主要结局
New antimicrobial-resistant bloodstream infection
时间窗: 6 years
Antimicrobial-resistant (AMR) bloodstream infection (BSI) is defined as having blood culture positive for methicillin-resistant S. aureus (MRSA), vancomycin-resistant Enterococcus spp., 3rd-generation cephalosporin-resistant Gram-negative bacterium and carbapenem-resistant Gram-negative bacterium from day 8 to day 30 after starting a parenteral antibiotic therapy.
In-hospital 30-day mortality
时间窗: 6 years
In-hospital mortality is defined as having discharge outcomes recorded as 'death without autopsy', 'death with autopsy' or 'died'. In hospital 30-day mortality will be defined as having in-hospital mortality from day 8 to day 30 after starting a parenteral antibiotic therapy from day 8 to day 30 after starting a parenteral antibiotic therapy.
次要结局
- Sensitivity of automated outbreak detection systems(5 years, from 2020 to 2024)
- Specificity of automated outbreak detection systems(5 years, from 2020 to 2024)
- Positive predictive value (PPV) of automated outbreak detection systems(5 years, from 2020 to 2024)
- Day of therapy (DOT) per 1,000 bed-days(6 years)
- Negative predictive value (NPV) of automated outbreak detection systems(5 years, from 2020 to 2024)
- Length of therapy (LOT) per 1,000 bed-days(6 years)
- Frequency of antimicrobial resistance bloodstream infection(6 years)
- Utility of new AMS indicators(6 years)