Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19 (MICROVID)
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|ClinicalTrials.gov Identifier: NCT04359706|
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : August 6, 2020
|Condition or disease|
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.
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2|
|Actual Study Start Date :||May 8, 2020|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||September 2020|
Critically ill patients with SARS-CoV-2 infection
Historical critically ill patients with no SARS-CoV-2 infection
- Composition of the fecal bacterial and fungal microbiota [ Time Frame: At 28 days ]relative abundances and diversity indices
- Analysis of the faecal microbiota from rectal swab [ Time Frame: 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
- Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid [ Time Frame: 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 [ Time Frame: at 28 days, ]Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline
- Inflammatory markers changes [ Time Frame: at 28 days, ]changes in Cytokine/ chemokine from baseline
- Mortality [ Time Frame: at 28 days, ]death
- mechanical ventilation free days [ Time Frame: at 28 days, ]Number of days alive without mechanical ventilation
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359706
|Contact: Saad Nseir, MD,PhD||0320445962 ext +email@example.com|
|Hôpital Roger Salengro, CHU Lille||Recruiting|
|Lille, France, 59037|
|Principal Investigator: Saadalla NSEIR, MD,PhD|
|Principal Investigator:||Saad Nseir, MD,PhD||University Hospital, Lille|