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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04359706
Recruitment Status : Recruiting
First Posted : April 24, 2020
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease
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.

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Bacterial and Fungal Microbiota of Patients With Severe Viral Pneumonia With SARS-CoV2
Actual Study Start Date : May 8, 2020
Estimated Primary Completion Date : September 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Molds Pneumonia

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



Primary Outcome Measures :
  1. Composition of the fecal bacterial and fungal microbiota [ Time Frame: At 28 days ]
    relative abundances and diversity indices


Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples With DNA
bronchoalveolar lavage and rectal swabs


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients suspected of SARS-CoV2 infection and admitted in ICU
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04359706


Contacts
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Contact: Saad Nseir, MD,PhD 0320445962 ext +33 saadalla.nseir@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU Lille Recruiting
Lille, France, 59037
Contact    0320445962      
Principal Investigator: Saadalla NSEIR, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Saad Nseir, MD,PhD University Hospital, Lille
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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT04359706    
Other Study ID Numbers: 2020_28
2020-A01042-37 ( Other Identifier: ID-RCB number,ANSM )
First Posted: April 24, 2020    Key Record Dates
Last Update Posted: August 6, 2020
Last Verified: April 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pneumonia, Viral
Pneumonia
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Virus Diseases