COVID-19 Associated Pulmonary Aspergillosis (CAPA) and Other Invasive Fungal Infections (IFI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- Participants with all cause mortality
研究概览
简要总结
The purpose of this study is to identify the number of individuals with severe CoVID who require ventilator support and who develop serious fungal infections. The study is an observational study, meaning that we are not providing any intervention that does not involve usual standard of care. Our chief goal is to find evidence of fungal infection by using traditional, approved methods of diagnosis, but by applying these methods in the same way and frequency among all study participants. We will be looking especially for evidence of a fungal infection known as Aspergillus, which can causes a serious lung infection called invasive aspergillosis (IA).
详细描述
COVID-19 is a disease caused by infection with the novel coronavirus SARS-COV2 which emerged in late 2019 in Wuhan, China (1). This illness is associated with viral prodromal symptoms, then subsequently fever, cough, and shortness of breath (1). In a subset of patients, lower respiratory tract infection associated with respiratory failure develops. Among these patients, progression to severe respiratory failure and ARDS requiring ventilator support has occurred in an alarming number of patients at rates that are many-fold higher than what is typically associated with seasonal influenza A or B (2). One of the most feared complications of post-influenza respiratory failure is the development of invasive pulmonary aspergillosis which may occur in as many as 15-20% of those requiring ventilator support (based on European data) (3-6). Among those developing IA following influenza A or B, mortality of 50% or greater is reported (3-6).
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
- •Adults aged 18 years or older at the time of enrollment
- •SARS-COV2 positivity by PCR with respiratory failure requiring mechanical ventilation for at least 72 hours
- •Prior therapy with antifungals, including prophylaxis, is NOT an exclusion.
排除标准
- •Life expectancy of less than 72 hours as determined by the site investigator.
- •Expected to be weaned from mechanical ventilation in next 24 hours
- •Care received in any setting other than an intensive care unit (ICU) at the time of enrollment
研究组 & 干预措施
COVID Patients with Aspergillosis and Other fungal Infections
All patients have been diagnosed with COVID-19. The purpose of this study is to look at this group of patients in the potential to develop Aspergillosis and other fungal infections.
干预措施: Observation to monitor patients for these infections (Other)
结局指标
主要结局
Participants with all cause mortality
时间窗: In 60 days
Participants with all cause mortality in SARS-CoV-2
Participants requiring mechanical ventilation
时间窗: 72 hours or greater
Number of patients placed on a ventilator
Participants with all cause mortality
时间窗: In 30 days
Participants with all cause mortality in SARS-CoV-2
次要结局
- Participants at risk for developing CAPA or IFIs(180 days)
研究者
Peter Pappas
Principle Investigator
University of Alabama at Birmingham