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临床试验/NCT05707156
NCT05707156已完成不适用

Prospective Observational Study on the Incidence of Opportunistic Fungal Infections Among Non-HIV Non Transplant Patients by Systemic Corticosteroids Dose

University of Colorado, Denver1 个研究点 分布在 1 个国家目标入组 12,032 人开始时间: 2023年7月5日最近更新:
适应症

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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