Prospective Observational Study on the Incidence of Opportunistic Fungal Infections Among Non-HIV Non Transplant Patients by Systemic Corticosteroids Dose
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 12,032
- 试验地点
- 1
- 主要终点
- Aspergillosis
研究概览
简要总结
Corticosteroids exposure is a common risk factor for invasive fungal infections. Systemic corticosteroid therapy treats several medical conditions, including rejection in solid organ transplant recipients, malignancy, and autoimmune or inflammatory diseases. Corticosteroid exposure is a well-known risk factor for developing PJP. Still, it remains unclear how prior corticosteroid exposure influences the presentation, severity, and mortality of opportunistic fungal infections. The investigators aim to prospectively characterize the corticosteroid use as a dose response to inform risk of invasive fungal infections.
详细描述
The investigators will use TriNetX, a global federated research network that captures anonymous data from electronic medical records (EMRs) of 66 healthcare organizations. The investigators are setting up a prospective observation study of non-HIV, non-transplant (NHNT) patients who are receiving systemic (oral or intravenous) corticosteroids for more than 2 weeks. The investigators are planning on excluding individuals younger than 18 years old with any prior history of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis. The investigators will follow 3 cohorts of patients based on their daily cumulative prednisone equivalent dose in mg. Group 1: 0-10 mg a day, group 2: 10-20 mg a day, group 3: > 20 mg daily. The investigators will record any incidence of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis based on ICD-10 codes or labs results at 3-6 months intervals. The investigators will record as well additional clinical features for patients including demographics, comorbidities, medications, and limited labs.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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 on systemic corticosteroids for more than 2 weeks
排除标准
- •HIV infection
- •Transplant status
- •Younger than 18 years of age
- •Previous history of Cryptococcosis, Aspergillosis, Pneumocystis jirovecii pneumonia or invasive candidiasis
结局指标
主要结局
Aspergillosis
时间窗: 3-6 months after first corticosteroid use
Number of cases of Aspergillosis
PJP
时间窗: 3-6 months after first corticosteroid use
Number of cases of Pneumocystis jirovecii pneumonia
Cryptococcosis
时间窗: 3-6 months after first corticosteroid use
Number of cases of cryptococcosis
Candidiasis
时间窗: 3-6 months after first corticosteroid use
Number of cases of Candidiasis
次要结局
- Hospitalization(3-6 months after first corticosteroid use)
- Mortality(3-6 months after first corticosteroid use)
