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Completed

NCT Number: NCT04359706

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

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.

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Key information

Conditions

Sars-CoV2

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hôpital Roger Salengro, CHU Lille

Lille, 59037, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Composition of the fecal bacterial and fungal microbiota

    Time frame: At 28 days

    relative abundances and diversity indices

Secondary outcomes

  1. Analysis of the faecal microbiota from rectal swab

    Time frame: 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

  2. Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid

    Time frame: 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

  3. Serum inflammatory markers changes

    Time frame: at 28 days,

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

  4. Inflammatory markers changes

    Time frame: at 28 days,

    changes in Cytokine/ chemokine from baseline

  5. Mortality

    Time frame: at 28 days,

    death

  6. mechanical ventilation free days

    Time frame: at 28 days,

    Number of days alive without mechanical ventilation

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

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

Acronym: MICROVID

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Apr 24, 2020
Registry last updated
Oct 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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