Efficacy of an Antimicrobial Stewardship Intervention for Early Adaptation of Empirical Antibiotic Therapy in High-risk Neutropenic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 1
- 主要终点
- Total antibiotic use during hospital stay, expressed as days of therapy (DOT)
研究概览
简要总结
Febrile neutropenia (FN) is a frequent and serious complication in patients with hematological malignancies undergoing intensive chemotherapy. The growth of antibiotic resistance is a major threat in high-risk neutropenic patients given that delay in introduction of appropriate empirical antibiotic therapy (EAT) in this population is associated with increased morbidity and mortality.
In 2013, the 4th European Conference on Infections in Leukaemia (ECIL-4) group published new guidelines, promoting early adaptation of EAT in stable afebrile patients, regardless of neutrophil count and expected duration of neutropenia. Despite these evidence-based guidelines, discontinuation and de-escalation strategies are not widely implemented in hematology departments. However, recent studies have found that early adaptation of EAT is safe and feasible and could lead to reduced antibiotic consumption.
In response to growing antibiotic resistance and low adherence to ECIL-4 guidelines in the hematology department in the center of Nice, the investigators have developed and implemented a multifaceted AMS intervention. This intervention aimed to improve the quality of febrile neutropenia management and to promote the adoption of early de-escalation and discontinuation strategies in high-risk neutropenic patients by our hematology team.
The aim of this before-after study was to assess the impact of a multifaceted AMS intervention, promoting early adaptation of empirical antibiotic therapy, on antibiotic consumption and clinical outcomes in high-risk neutropenic patients. Secondly, the investigators sought to assess the applicability and adherence to de-escalation and discontinuation strategies by the hematology team.
The primary endpoint was total antibiotic use during hospital stay, expressed as days of therapy (DOT). DOT was defined as the number of days that a patient received antibiotics regardless of the dose. Secondary endpoints included length of therapy (LOT), antibiotic-free days (AFD), 30-day mortality, ICU admission, Clostridium difficile infection and duration of stay. LOT was defined as the number of days that a patient received systemic antibiotic therapy, irrespective of the number of different antibiotics.
详细描述
INTRODUCTION
Febrile neutropenia (FN) is a frequent and serious complication in patients with hematological malignancies undergoing intensive chemotherapy. FN episodes are responsible for repeated and prolonged antibiotic therapy, leading to an increased risk of bacterial antibiotic resistance, Clostridium difficile infections, fungal infections and adverse drug events. The growth of antibiotic resistance is a major threat in high-risk neutropenic patients given that delay in introduction of appropriate empirical antibiotic therapy (EAT) in this population is associated with increased morbidity and mortality.
Excessive and inappropriate antibiotic use are major drivers of the growth of antibiotic resistance. Antimicrobial stewardship (AMS) interventions have therefore been introduced to optimize antibiotic use in order to decrease unintended consequences of antibiotic use, such as growing antibiotic resistance and excessive healthcare costs. AMS interventions often include various components, such as prescriber education, prospective audit and feedback as well as clinical decision support at the point-of-care.
In 2013, the 4th European Conference on Infections in Leukaemia (ECIL-4) group published new guidelines, promoting early adaptation of EAT in stable afebrile patients, regardless of neutrophil count and expected duration of neutropenia. Despite these evidence-based guidelines, discontinuation and de-escalation strategies are not widely implemented in hematology departments. However, recent studies have found that early adaptation of EAT is safe and feasible and could lead to reduced antibiotic consumption. However, some of these studies did not use a control group. Furthermore, some of these studies solely investigated the effets of one aspect of adaptation (i.e. de-escalation or discontinuation) or focused on specific clinical presentations or patient profiles. One interrupted time series study investigated the impact of de-escalation and discontinuation strategies on antibiotic consumption but found no significant difference in total antibiotic consumption.
In response to growing antibiotic resistance and low adherence to ECIL-4 guidelines in the hematology department in our center, the investigators have developed and implemented a multifaceted AMS intervention. This intervention aimed to improve the quality of febrile neutropenia management and to promote the adoption of early de-escalation and discontinuation strategies in high-risk neutropenic patients by our hematology team.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Retrospective
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
- •All patients admitted to the hematology department for intensive chemotherapy, with chemotherapy-induced neutropenia lasting 7 days or more, who experienced at least one febrile episode, were eligible for inclusion.
排除标准
- •Younger than 18 years old
- •Had chemotherapy-induced neutropenia for less than 7 days or received corticosteroids.
结局指标
主要结局
Total antibiotic use during hospital stay, expressed as days of therapy (DOT)
时间窗: 31 months
DOT was defined as the number of days that a patient received antibiotics regardless of the dose. When a patient received more than one antibiotic, more than one DOT was counted.
次要结局
- ICU admission rate(31 months)
- Duration of hospital stay(31 months)
- Total antibiotic use during hospital stay, expressed as days of therapy (LOT)(31 months)
- 30-day mortality rate(31 months)
- Antibiotic-free days (AFD)(31 months)
- Clostridium difficile infection rate(31 months)