Impact Assessment of a Clinical Decision Support Tool for Non-invasive Antibiotic Allergy Label Delabeling and Refinement
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 3,000
- 试验地点
- 1
- 主要终点
- First line antibiotic use: yes (1)/no (0)
研究概览
简要总结
Antibiotic allergy labels (AAL) are reported in 7% of inpatient's charts, especially for beta-lactams (86% of AAL, i.e., prevalence of 6%). They are associated with increased length of hospital stay, and use of second-line and broad-spectrum antibiotics. Allergy workups are able to invalidate the majority of these AAL but are time-consuming and require invasive skin and provocation testing. The investigators recently evaluated, for the first time in Europa, a strictly non-invasive delabeling protocol using a questionnaire, medical file search and contact with primary care health care workers in 200 adult internal medicine inpatients with a beta-lactam AAL. Up to half of the AAL could be removed or refined, demonstrating the potential of this strategy. In this project, they aim to assess the impact of using the non-invasive 'AAL-fact-check' tool in a multicenter study, on antibiotic selection, and clinical, antimicrobial, and economic endpoints, as compared with the standard of care (i.e., no AAL-fact-check tool).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Crossover
- 主要目的
- Diagnostic
- 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
- 是
入选标准
- •Hospitalized patients
- •AAL for one or more beta-lactams
排除标准
- •Age younger than 18
- •Previous enrolment in this study
结局指标
主要结局
First line antibiotic use: yes (1)/no (0)
时间窗: Until 100 days after discharge
First line and/or narrow-spectrum beta-lactam antibiotic use (depending on the index indication, and following the guidelines of the Belgian Antibiotic Policy Coordination Commission BAPCOC), as a binary outcome.
次要结局
- Need to switch antibiotics: yes (1)/no (0)(Until 100 days after discharge)
- Days until clinical recovery (days)(Until 14 days after discharge)
- In-hospital mortality: yes (1)/no (0)(Until 14 days after discharge of discharge/death)
- Antibiotic allergy label removed: yes (1)/no (0)(Until 100 days after discharge)
- Antibiotic allergy label refined: yes (1)/no (0)(Until 100 days after discharge)
- Beta-lactam antibiotic tolerance: yes (1)/no (0)(Until 100 days after discharge)
- 3 months post-hospitalization mortality: yes (1)/ no (0)(Until 14 days after discharge)
- Length of hospital stay (days)(Until 14 days after discharge)
- Admission to ICU: yes (1)/no (0)(Until 14 days after discharge)
- Readmission within 3 months after discharge: yes (1)/no (0)(Until 100 days after discharge)
- Colonization with MRSA: yes (1)/no (0)(Until 100 days after discharge)
- Infection with MRSA: yes (1)/no (0)(Until 100 days after discharge)
- Colonization with VRE: yes (1)/no (0)(Until 100 days after discharge)
- Infection with VRE: yes (1)/no (0)(Until 100 days after discharge)
- Colonization with C.Diff: yes (1)/no (0)(Until 100 days after discharge)
- Infection with C.Diff: yes (1)/no (0)(Until 100 days after discharge)
- Cost of antibiotic treatment (euro)(Until 14 days after discharge)
- Cost of hospitalization (euro)(Until 14 days after discharge)
- Time needed to perform the AAL fact-check (minutes)(Until 14 days after discharge)
- Cost of human resources needed for AAL-fact-check (euro)(Until 14 days after discharge)