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

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

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.

Study Overview

• Status: Completed
• Conditions: Sars-CoV2

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 Type: Observational
• Enrollment (Actual): 34

Contacts and Locations

Study Locations

• France
  • Lille, France, 59037
    • Hopital Roger Salengro, CHU Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

patients suspected of SARS-CoV2 infection and admitted in ICU

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Covid-19 group; Critically ill patients with SARS-CoV-2 infection
control group; Historical critically ill patients with no SARS-CoV-2 infection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Composition of the fecal bacterial and fungal microbiota	relative abundances and diversity indices	At 28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
Serum inflammatory markers changes	Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline	at 28 days,
Inflammatory markers changes	changes in Cytokine/ chemokine from baseline	at 28 days,
Mortality	death	at 28 days,
mechanical ventilation free days	Number of days alive without mechanical ventilation	at 28 days,

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): May 8, 2020
• Primary Completion (Actual): October 23, 2020
• Study Completion (Actual): October 23, 2020

Study Registration Dates

• First Submitted: April 21, 2020
• First Submitted That Met QC Criteria: April 21, 2020
• First Posted (Actual): April 24, 2020

Study Record Updates

• Last Update Posted (Actual): October 17, 2022
• Last Update Submitted That Met QC Criteria: October 14, 2022
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Lung Diseases; Pneumonia; Pneumonia, Viral
• Other Study ID Numbers: 2020_28; 2020-A01042-37 (Other Identifier: ID-RCB number,ANSM)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No