Community-acquired Pneumonia: Increasing Protocol Adherence by Antibiotic Stewardship in a Stepped Wedge Cluster- Randomized Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- UMC Utrecht
- 入组人数
- 4,084
- 试验地点
- 12
- 主要终点
- 90-day mortality
研究概览
简要总结
The purpose of this study is to determine the effect of a multifaceted antibiotic stewardship intervention on protocol adherence of moderate-severe community-acquired pneumonia.
详细描述
The purpose of the study is to show a decrease in broad-spectrum antibiotics with a non-inferiority in 90-day mortality. Hospitals with a pre-intervention protocol adherence of >70% are excluded from the primary analysis. Primary analysis will be done with a mixed effects model with a random effects for clusters and time. Crude outcomes and outcomes adjusted for potential confounders will be reported. Primary analysis will be tested one-sided for a decrease in mortality. Secondary analysis to test two-sided for mortality will be performed.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- None
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
- •Patients diagnosed with CAP who get admitted to a non-ICU department are eligible for inclusion.
排除标准
- •Patients aged below 18 years
- •Residence in a nursing home or long-term care facility in the last 14 days
- •Patients hospitalized in an acute care hospital for two or more days in the last 14 days
- •Patients with a history of Cystic Fibrosis
- •Patients with immunodeficiency, defined as having one or more of the following criteria:
- •HIV infection with a last CD4 count of <300//μL
- •Cytotoxic chemotherapy or radiotherapy in the previous 3 months
- •Chronic hemodialysis > 3 months
- •History of receiving an organ or bone marrow transplant
- •Using immunosuppressive therapy, include corticosteroid treatment only when dosage is high (>0,5mg/kg/day) for a longer period of time (>14 days)
研究组 & 干预措施
Control
Patients will be treated as standard of care.
Antibiotic Stewardship Intervention
Patients will be treated as standard of care. The Antibiotic Stewardship Intervention will be targeted at the physicians treating the community-acquired pneumonia patients. The purpose of the intervention is to increase prescription concordance with the national guideline for community-acquired pneumonia.
干预措施: Antibiotic Stewardship Intervention (Behavioral)
结局指标
主要结局
90-day mortality
时间窗: 90-days after hospital admission
All-cause mortality on day 90 from admission will be assessed from the municipal personal records database
Broad-spectrum antibiotic use
时间窗: Participants will be followed for the duration of hospital stay, an expected average of 1 week
Antibiotic use will be registered during hospital stay
次要结局
- Clostridium difficile infections(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Hospital readmissions(Hospital readmissions within 30 days of hospital admission will be registered)
- Antibiotic switches(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- 30-day mortality(30-days after hospital admission)
- Length of hospital stay(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Length of intravenous antibiotic treatment(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Complications(Participants will be followed for the duration of hospital stay, an expected average of 1 week)
- Intensive Care admissions(Participants will be followed for the duration of hospital stay, an expected average of 1 week)