CClinicalTrials.gg
CompletedNCT04359706MICROVIDUpdated Oct 17, 2022

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

An observational study in Sars-CoV2, sponsored by University Hospital, Lille. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-10-17.

Sponsored by University Hospital, Lille · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
34
Ages
18 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Sars-CoV2
03

In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 34 is below the median of 203 across 688 observational studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

University Hospital, Lille is the lead sponsor of 625 studies on the registry; 141 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

patients suspected of SARS-CoV2 infection and admitted in ICU

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

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
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
34 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • Covid-19 group

    Critically ill patients with SARS-CoV-2 infection

  • control group

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

06

What researchers measure

Primary outcomes

  1. Composition of the fecal bacterial and fungal microbiota

    relative abundances and diversity indices

    Time frame: At 28 days

Secondary outcomes

  1. 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

    Time frame: at baseline and every 7 days during 28 days

  2. 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

    Time frame: at baseline and every 7 days during 28 days

  3. Serum inflammatory markers changes

    Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline

    Time frame: at 28 days,

  4. Inflammatory markers changes

    changes in Cytokine/ chemokine from baseline

    Time frame: at 28 days,

  5. Mortality

    death

    Time frame: at 28 days,

  6. mechanical ventilation free days

    Number of days alive without mechanical ventilation

    Time frame: at 28 days,

07

Study locations

1 site
  • Hôpital Roger Salengro, CHU Lille
    Lille, 59037, France
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04359706
Lead sponsor
University Hospital, Lille
Responsible party
Sponsor
First posted
Apr 24, 2020
Start date
May 8, 2020
Primary completion
Oct 23, 2020
Completion
Oct 23, 2020
Last update
Oct 17, 2022

Study contacts

Saad Nseir, MD,PhD
principal investigator · University Hospital, Lille

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2020. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion