Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With COVID-19

Sars-CoV2 Clinical Trial

— MICROVID  

Official title:

Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04359706
• Other study ID #: 2020_28
• Secondary ID: 2020-A01042-37
• Status: Completed
• Start date: May 8, 2020
• Est. completion date: October 23, 2020

Study information

• Verified date: April 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: October 23, 2020
• Est. primary completion date: October 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pneumonia
• Pneumonia, Viral
• Sars-CoV2

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Composition of the fecal bacterial and fungal microbiota	relative abundances and diversity indices	At 28 days
Secondary	Analysis of the faecal microbiota from rectal swab	Alterations in fecal microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls	at baseline and every 7 days during 28 days
Secondary	Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid	Alterations in respiratory microbiota composition (including virose, bacteria and fungi) in COVID-19 patients compared with controls	at baseline and every 7 days during 28 days
Secondary	Serum inflammatory markers changes	Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline	at 28 days,
Secondary	Inflammatory markers changes	changes in Cytokine/ chemokine from baseline	at 28 days,
Secondary	Mortality	death	at 28 days,
Secondary	mechanical ventilation free days	Number of days alive without mechanical ventilation	at 28 days,