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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04359706
Other study ID # 2020_28
Secondary ID 2020-A01042-37
Status Completed
Phase
First received
Last updated
Start date May 8, 2020
Est. completion date October 23, 2020

Study information

Verified date April 2020
Source University Hospital, Lille
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 34
Est. completion date October 23, 2020
Est. primary completion date October 23, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
France Hôpital Roger Salengro, CHU Lille Lille

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Composition of the fecal bacterial and fungal microbiota relative abundances and diversity indices At 28 days
Secondary 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 at baseline and every 7 days during 28 days
Secondary 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 at baseline and every 7 days during 28 days
Secondary Serum inflammatory markers changes Changes in blood, c-reactive protein, leucocyte, lymphocyte from baseline at 28 days,
Secondary Inflammatory markers changes changes in Cytokine/ chemokine from baseline at 28 days,
Secondary Mortality death at 28 days,
Secondary mechanical ventilation free days Number of days alive without mechanical ventilation at 28 days,
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