NCT05065658已完成不适用
Posaconazole for the Prevention of COVID-19 Associated Pulmonary Aspergillosis in Critically-Ill Patients: A European Multicenter Case-Control Study
Medical University of Graz3 个研究点 分布在 3 个国家目标入组 249 人开始时间: 2020年3月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 249
- 试验地点
- 3
- 主要终点
- Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)
研究概览
简要总结
COVID-19 associated pulmonary aspergillosis (CAPA) is considered a potentially life-threatening infection in critically ill COVID (Corona Virus disease)-19 patients. This study will investigate the efficacy of mold-active prophylaxis with posaconazole for patients with severe SARS (severe acute respiratory syndrome)-CoV-2 infection admitted to the ICU (intensive care unit) in a multi-center case-control study in Europe.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 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
- 否
入选标准
- •Adult patient (> 18 years)
- •PCR (polymerase chain reaction) -confirmed SARS-CoV-2 infections based on nasopharyngeal swab (NPS), oropharyngeal swab (OPS), tracheal aspirate (TA), bronchial aspirate (BA), or bronchoalveolar lavage fluid (BALF) within 14 days prior to ICU admission or within 72 hours following ICU admission due to severe COVID-19 infection
- •Radiographic imaging consistent with SARS-CoV-2 infection (e.g. atypical pneumonia, organizing pneumonia, ground glass opacities) or ARDS within 7 days of diagnosis of SARS-CoV-2 infection
排除标准
- •Patients with a diagnosis of invasive aspergillosis/detection of Aspergillus spp. by culture from sputum, TA, BA, or BALF or positive GM from serum, TA, or BALF at baseline (=ICU admission)
- •History of invasive aspergillosis within the prior six months
- •Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
- •Patients that are being treated with mold-active antifungal agents for invasive aspergillosis or another invasive fungal infection
- •Death or transfer to general ward within 48 hours of ICU admission
- •Antifungal prophylaxis other than posaconazole (e.g. inhaled amphotericin B)
研究组 & 干预措施
Critically-ill COVID-19 patients receiving posaconazole prophylaxis
干预措施: Posaconazole (Drug)
结局指标
主要结局
Incidence of COVID-19 Associated Pulmonary Aspergillosis (CAPA)
时间窗: ICU admission to ICU discharge. On average 20 days
Compare the incidence of CAPA at time of discharge from the ICU in those who received posaconazole compared to controls who did not
次要结局
- Risk Factors for CAPA Development (EORTC/MSGERC)(ICU admission to ICU discharge. On average 20 days)
- Risk Factors for CAPA Development (ECMO)(ICU admission to ICU discharge. On average 20 days)
研究者
研究点 (3)
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