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

NCT ID: NCT04359706

Last Updated: 2022-10-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

34 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-05-08

Study Completion Date

2020-10-23

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sars-CoV2

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Covid-19 group

Critically ill patients with SARS-CoV-2 infection

No interventions assigned to this group

control group

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

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Lille

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Saad Nseir, MD,PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Lille

Locations

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Hôpital Roger Salengro, CHU Lille

Lille, , France

Site Status

Countries

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France

Other Identifiers

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2020-A01042-37

Identifier Type: OTHER

Identifier Source: secondary_id

2020_28

Identifier Type: -

Identifier Source: org_study_id

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