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

NCT04359706 | Completed

• 2 other identifiers: 2020_282020-A01042-37
• Study Type: observational
• Target: 34
• Locations: 1 country
• Sites: 1

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.

Conditions

Sars-CoV2

Outcome Measures

Primary Outcomes (1)

• Composition of the fecal bacterial and fungal microbiota

  relative abundances and diversity indices

  At 28 days

Secondary Outcomes (6)

• Analysis of the faecal microbiota from rectal swab

  at baseline and every 7 days during 28 days

• Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid

  at baseline and every 7 days during 28 days

• Serum inflammatory markers changes

  at 28 days,

• Inflammatory markers changes

  at 28 days,

• Mortality

  at 28 days,

Study Arms (2)

Covid-19 group

Critically ill patients with SARS-CoV-2 infection

control group

Historical critically ill patients with no SARS-CoV-2 infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients suspected of SARS-CoV2 infection and admitted in ICU

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU Lille

Lille, 59037, France

Location

Biospecimen

Retention: SAMPLES WITH DNA

bronchoalveolar lavage and rectal swabs

Study Officials

• Saad Nseir, MD,PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 21, 2020
• First Posted: April 24, 2020
• Study Start: May 8, 2020
• Primary Completion: October 23, 2020
• Study Completion: October 23, 2020
• Last Updated: October 17, 2022

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)