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

Completed

• Conditions: Sars-CoV2

• Registration Number: NCT04359706
• Lead Sponsor: University Hospital, Lille

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.

Study Timeline

• Status Verified: 2020-04
• Study First Submitted: 2020-04-21
• Study First Submitted QC: 2020-04-21
• Study First Posted: 2020-04-24
• Study Start: 2020-05-08
• Primary Completion: 2020-10-23
• Study Completion: 2020-10-23
• Last Update Submitted: 2022-10-14
• Last Update Posted: 2022-10-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 34

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Composition of the fecal bacterial and fungal microbiota	At 28 days	relative abundances and diversity indices

Secondary Outcome Measures

Name	Time	Method
Mortality	at 28 days,	death
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
mechanical ventilation free days	at 28 days,	Number of days alive without mechanical ventilation
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
Inflammatory markers changes	at 28 days,	changes in Cytokine/ chemokine from baseline

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU Lille; 🇫🇷 Lille, France