The Diagnosis of Superinfections in Mechanically Ventilated Covid-19 Patients
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Superinfection incidence
研究概览
简要总结
Patients with severe Coronavirus Disease 2019 (Covid-19) pneumonia depending on mechanical ventilation are at risk of superinfections, especially infections of respiratory tract. This multicententer prospective observational study is focused on early diagnosis of respiratory tract superinfections and identification of risk factors (immunosuppressive therapy,...). Investigators will use bronchoalveolar lavage fluid (BALF) for Polymerase Chain Reaction (PCR) detection of pathogens and antigenic detection of mycoses.
This project can support the routine use of BALF and PCR diagnostics for early detection of pathogens. Data will be compared with historical cohort of patients without routine BAL.
详细描述
Prospective, observational multicenter study
The inclusion criteria are as follows:
Age > 18 years Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) PCR positivity in the last 21 days Mechanical ventilation for Covid-19 pneumonia Presence of lung infiltrations on the chest X-ray or ground glass opacity, crazy paving or lung infiltrations on the chest CT Oxygenation disorder according to Acute Respiratory Distress Syndrome (ARDS) definition: Partial Pressure of Oxygen in Arterial Blood (PaO2) / fraction of inspired oxygen (FiO2) <300 mmHg with positive end expiratory pressure (PEEP) at least 5 cmH2O
The exclusion criteria are as follows:
Disagreement with the inclusion in the trial
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
- •Age > 18 years
- •SARS-CoV-2 PCR positivity in the last 21 days
- •Mechanical ventilation for Covid-19 pneumonia
- •Presence of lung infiltrations on the chest X-ray or ground glass opacity, crazy paving or lung infiltrations on the chest CT
- •Oxygenation disorder according to ARDS definition: PaO2 / FiO2 <300 mmHg with PEEP at least 5 cmH2O
排除标准
- •Disagreement with the inclusion in the trial
结局指标
主要结局
Superinfection incidence
时间窗: 1 year
The incidence and characteristics of superinfections in patients with Coronavirus Disease 2019 (COVID-19).
次要结局
- The aasociation inflammation diagnostic values and the diagnosis of superinfection(1 year)
- The differention of superinfection diagnosis between historical cohort and actual cohort.(1 year)
研究者
Jan Hudec, MD
physician
Brno University Hospital