Observational Disease Registry of Patients Treated With Systemic Mold-Active Triazoles
概览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,015
- 试验地点
- 55
- 主要终点
- Treatment patterns of care assessed by use of diagnostic method(s)
概览
简要总结
The purpose of this study is to describe representative real-world patterns of care for the management of invasive fungal infections (IFIs), including invasive mold infection (IMI). Specifically, the study goals are to examine real world patient characteristics and treatment patterns, associated healthcare resource utilization, and outcomes associated with use of mold-active triazoles (MATs) to treat invasive fungal infections (IFIs).
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients taking one of the following target drugs at the time of enrollment: isavuconazonium sulfate (ISAV), voriconazole (VORI), posaconazole (POSA).
排除标准
- •Currently enrolled in any clinical trial with an investigational antifungal agent. Individuals who subsequently enroll in an investigational antifungal study will be discontinued and data collected up to the time of investigational product will be evaluable.
- •Patients who died before entering the study.
- •Patients who previously participated in this registry.
研究组 & 干预措施
Isavuconazonium sulfate Group
Oral and Intravenous
干预措施: Isavuconazonium sulfate (Drug)
Voriconazole Group
Oral and Intravenous
干预措施: Voriconazole (Drug)
Posaconazole Group
Oral and Intravenous
干预措施: Posaconazole (Drug)
结局指标
主要结局
Treatment patterns of care assessed by use of diagnostic method(s)
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by category of diagnosis at time of therapy initiation
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by occurrence of drug-drug interactions (DDI)
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by reason for therapy
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by onset of treatment/prophylaxis
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by use of therapeutic drug monitoring (TDM)
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by discontinuation due to adverse events (AEs) or other reasons
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Patient characteristics assessed by underlying host/risk factors
时间窗: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by patient baseline characteristics
时间窗: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by fungal disease diagnosis
时间窗: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by pathogen susceptibility
时间窗: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Treatment patterns of care assessed by length of treatment/prophylaxis
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by type of diagnostic method(s) used
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Treatment patterns of care assessed by the sequence of invasive fungal infection treatment (IFI)
时间窗: 5 years
Assessments of patient patterns of care will be summarized by MAT treatment at baseline and overall.
Patient characteristics assessed by pathogen treated
时间窗: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
Patient characteristics assessed by site of fungal infection
时间窗: 5 years
The summaries of patient characteristics will be by MAT treatment at baseline and overall.
次要结局
- Overall healthcare resource utilization assessed by frequency of therapeutic drug monitoring (TDM)(5 years)
- Overall healthcare resource utilization assessed by length of stay at SNF or LTC facility(5 years)
- Overall healthcare resource utilization assessed by reason for admission to SNF or LTC facility(5 years)
- Overall healthcare resource utilization assessed by incidence of hospital readmissions at 30 and 90 days within a 5-year period(5 years)
- Overall healthcare resource utilization assessed by time spent in Intensive Care Unit (ICU)(5 years)
- Overall healthcare resource utilization assessed by time spent on ventilator in ICU(5 years)
- Overall healthcare resource utilization assessed by number of additional fungal specific diagnostics and interventions after MAT initiation(5 years)
- Overall healthcare resource utilization assessed by incidence of discharge to a skilled nursing facility (SNF) or long term care (LTC) facility(5 years)
- Overall healthcare resource utilization assessed by hospitalization length of stay (LOS)(5 years)
- Overall healthcare resource utilization assessed by primary reason for outpatient office visits within 30 and 90 days within a 5-year period(5 years)
- Overall healthcare resource utilization assessed by duration of hospital readmissions at 30 and 90 days within a 5-year period(5 years)
- Overall healthcare resource utilization assessed by outpatient utilization(5 years)
- Overall healthcare resource utilization assessed by frequency of outpatient visits within 30 and 90 days within a 5-year period(5 years)