Bacterial and Fungal Microbiota of Patients With Severe V... | NCT04359706

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

NCT04359706

Sponsor

University Hospital, Lille

Status

Completed

Last Update Posted

Oct 17, 2022Actual

Enrollment

34Actual

Phase

Not provided

Conditions

Sars-CoV2

Interventions

Not provided

Countries

France

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2020-A01042-37	Other Identifier	ID-RCB number,ANSM

Status Module

Record Verification Date

Apr 2020

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 8, 2020Actual

Primary Completion Date

Oct 23, 2020Actual

Completion Date

Oct 23, 2020Actual

First Submitted Date

Apr 21, 2020

First Submission Date that Met QC Criteria

Apr 21, 2020

First Posted Date

Apr 24, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 14, 2022

Last Update Posted Date

Oct 17, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

34Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Covid-19 group		Critically ill patients with SARS-CoV-2 infection
control group		Historical critically ill patients with no SARS-CoV-2 infection

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Composition of the fecal bacterial and fungal microbiota	relative abundances and diversity indices	At 28 days

Secondary Outcomes

Measure	Description	Time Frame
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
Analysis of the respiratory microbiota from the bronchoalveolar lavage liquid

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

patients suspected of SARS-CoV2 infection and admitted in ICU

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Saad Nseir, MD,PhD	University Hospital, Lille	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Roger Salengro, CHU Lille		Lille		59037	France

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided