Optimizing Antibiotic Use in Neonatal Intensive Care Units: A Collaborative Antimicrobial Stewardship Program in China
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 10,000
- 试验地点
- 26
- 主要终点
- Total antibiotic days of therapy (DOT) per 1000 patient-days
研究概览
简要总结
This project aims to reduce antibiotic use in Chinese neonatal intensive care units (NICU) by 1) developing an adaptable framework of NICU-targeted antimicrobial stewardship programs (ASP); 2) implementing the NICU-targeted ASP in NICUs using a collaborative quality improvement method; and 3) evaluating the impact of ASP implementation on neonatal antibiotic use.
详细描述
Antibiotics overuse has been a critical problem in Chinese NICUs associated with the emerging antimicrobial resistance crisis. NICU-targeted ASP have rarely been implemented in Chinese NICUs. Collaborative quality improvement methods have been shown to facilitate clinical practice changes and improve outcomes.
In this two-year interventional pre-and post-study, a NICU-targeted ASP will be developed and implemented in Chinese NICUs using the collaborative quality improvement method. The investigators hypothesize that implementing the targeted ASP using a collaborative quality improvement method will reduce the overall antibiotic days of therapy by 20% over a two-year period, comparing the last year of intervention and the last year of baseline period before ASP implementation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Health Services Research
- 盲法
- None
入排标准
- 年龄范围
- 0 Days 至 120 Days（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All infants born at ≤31+6 weeks' gestation and admitted to the participating NICUs between October 1st, 2019 and September 30th,
- •The period from October 1st, 2019 to September 30th, 2021 will be used as the baseline period before ASP intervention. Clinical data of eligible infants in this period will be retrospectively collected from a previously established database of preterm infants.
- •The ASP implementation will be initiated on October 1st,
- •The period from October 1st, 2021 to September 31st, 2023 will be the ASP intervention period and data will be prospectively collected.
排除标准
- •Infants who are transferred to non-participating NICUs within 24 hours after birth.
研究组 & 干预措施
Collaborative antimicrobial stewardship group
Collaborative antimicrobial stewardship intervention will be implemented in NICUs of this group.
干预措施: Collaborative Antimicrobial Stewardship Program (ASP) (Behavioral)
结局指标
主要结局
Total antibiotic days of therapy (DOT) per 1000 patient-days
时间窗: up to 180 days
DOT is calculated as the sum of days of antibiotics used per patient.
次要结局
- Incidence rate of infections caused by multi-resistant bacteria(up to 180 days)
- Total antibiotic days of therapy (DOT) per 1000 patient-days of third-generation cephalosporin(up to 180 days)
- Total antibiotic days of therapy (DOT) per 1000 patient-days of fourth-generation cephalosporin(up to 180 days)
- Total antibiotic days of therapy (DOT) per 1000 patient-days of piperacillin-tazobactam(up to 180 days)
- Total antibiotic days of therapy (DOT) per 1000 patient-days of carbapenem(up to 180 days)
- Total antibiotic days of therapy (DOT) per 1000 patient-days of vancomycin(up to 180 days)
- Total antibiotic days of therapy (DOT) per 1000 patient-days of linezolid(up to 180 days)
- Incidence rate of invasive fungal infections(up to 180 days)
- Incidence of mortality(up to 180 days)
- Incidences of major morbidities(up to 180 days)
- Length of hospital stay(up to 180 days)