Sars-CoV2
Conditions
Brief summary
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.
Detailed description
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.
Interventions
None listed
Sponsors
University Hospital, Lille
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
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).
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Composition of the fecal bacterial and fungal microbiota | At 28 days | relative abundances and diversity indices |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid | at baseline and every 7 days during 28 days | Alterations in respiratory microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls |
| Serum inflammatory markers changes | at 28 days, | Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline |
| Analysis of the faecal microbiota from rectal swab | at baseline and every 7 days during 28 days | Alterations in fecal microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls |
| Mortality | at 28 days, | death |
| mechanical ventilation free days | at 28 days, | Number of days alive without mechanical ventilation |
| Inflammatory markers changes | at 28 days, | changes in Cytokine/ chemokine from baseline |
Countries
France
Outcome results
None listed