Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Composition of the fecal bacterial and fungal microbiota
研究概览
简要总结
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.
详细描述
Observational pilot single-center study aiming to determine the microbiota of critically ill patients infected with SARS-CoV-2. COVID-19 patients will be compared to historical critically ill controls with no SARS-CoV-2 infection.
Respiratory and fecal microbiota (microbial and fungal) will be determined in COVID-19 patients on bronchoalveolar lavage and rectal swab.
Inflammatory biomarkers will also be measured in COVID-19 patients.
Characteristics of study patients will be collected at ICU admission and during ICU stay.
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
- •For the Covid-19 Group: with a confirmed severe lung infection with CoV2-SARS-Cov2 admitted to the ICU.
- •For the Control Group:
- •Historic cohort of non SARS -CoV2-infected adults admitted to the ICU (between March and October 2019),
- •that was investigated for fecal microbiota in a previous study (control patients in a fecal microbiota study in patients included in the SEAT study).
排除标准
- •For the Covid-19 group:
- •Lack of coverage Patients who received antibiotic therapy within 6 weeks prior to Covid-19 symptomatology,
- •Pregnant women,
- •Severe immunosuppression: Neutropenia < 0.5 G/L, Chemotherapy < 6 months, Bone marrow transplant recipients, HIV with CD4+ lymphocytes < 0.4 G/L
- •Impossible to perform bronchoalveolar lavage,
- •Non-socially insured,
- •Refusal to participate in the social study
结局指标
主要结局
Composition of the fecal bacterial and fungal microbiota
时间窗: At 28 days
relative abundances and diversity indices
次要结局
- Analysis of the faecal microbiota from rectal swab(at baseline and every 7 days during 28 days)
- mechanical ventilation free days(at 28 days,)
- Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid(at baseline and every 7 days during 28 days)
- Mortality(at 28 days,)
- Serum inflammatory markers changes(at 28 days,)
- Inflammatory markers changes(at 28 days,)