Ignite Creation Date:
2024-05-06 @ 3:32 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04669938
Status:
UNKNOWN
Last Update Posted:
2022-06-24
First Post:
2020-11-19
Brief Title:
Role of the Microbiota in the Evolution of the SARS-CoV-2 DiseaseCOVID-19 in Hospitalized Patients
Sponsor:
Assistance Publique - Hôpitaux de Paris
Organization:
Assistance Publique - Hôpitaux de Paris
Study Overview
Official Title:
Role of the Microbiota in the Evolution of the SARS-CoV-2 Disease in Hospitalized Patients
Status:
UNKNOWN
Status Verified Date:
2022-03
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
MicrobioCOVID
Brief Summary:
Patients hospitalized for COVID-19 may need intensive care eg mechanical ventilation during hospitalization Some risk factors are already known but better targeting of such patients is still needed at least because existing risk factors are not strong enough to provide an accurate prediction Care organization would benefit for such a predictive tool
Oropharyngeal and gut microbiota could potentially fill a significant gap in predictive performances The investigators therefore propose to sample 200 patients oropharyngeal and rectal swab admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care Aside metagenomic analyses The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients
For patients transferred in intensive care unit The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia
Microbiota data will be considered together with the host genotype the viral sequence and a deep immunological profiling to identify the main determinants of the evolution toward severity of COVID-19
Oropharyngeal and gut microbiota could potentially fill a significant gap in predictive performances The investigators therefore propose to sample 200 patients oropharyngeal and rectal swab admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care Aside metagenomic analyses The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients
For patients transferred in intensive care unit The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia
Microbiota data will be considered together with the host genotype the viral sequence and a deep immunological profiling to identify the main determinants of the evolution toward severity of COVID-19
Detailed Description:
Patients hospitalized for COVID-19 may need intensive care eg mechanical ventilation during hospitalization Some risk factors are already known eg sex comorbidities initial clinical presentation inflammatory cytokines but better targeting of such patients is still needed at least because existing risk factors are not strong enough to provide an accurate prediction Care organization would benefit for such a predictive tool
Oropharyngeal and gut microbiota could fill a significant gap in predictive performances The investigators therefore propose to take advantage of the French-COVID cohort and sample 200 patients oropharyngeal and rectal swab admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care Aside metagenomic analyses The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients
The genetic determinants of the host the patient could also be predictive of the severity of the disease and so does the immunological response to the COVID-19 Likewise it has been suggested that certain mutations notably the D614G mutation of the viral sequence could be associated with the infectivity of the virus
In addition to the direct role of the microbiota in the course of infection the immune characteristics specific to the host by themselves or in interaction with the microbiota could play an important role in the progression of the disease
This project focuses on the clinical characterization of COVID-19 and its evolution as well as disease management
The research focuses on 4 main areas
Characterization of the oropharyngeal and intestinal microbiota of patients with COVID-19
Characteristics of the host genotype
Immune characteristics of the host
Characteristics of the SARS-CoV-2 viral genome
For patients transferred in intensive care unit The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia
Oropharyngeal and gut microbiota could fill a significant gap in predictive performances The investigators therefore propose to take advantage of the French-COVID cohort and sample 200 patients oropharyngeal and rectal swab admitted in infectious disease department at Bichat Hospital and at high risk of needing intensive care during hospitalization The investigators plan to perform metagenomic sequencing and bioinformatic analysis of these samples to characterize the diversity of bacterial species present in the oropharynx and the gut and to identify new factors associated with the need for intensive care Aside metagenomic analyses The investigators will perform semi-quantitative cultures of the oropharyngeal and gut microbiota to identify and quantify pathogens in order to predict the risk of bacterial infections in COVD-19 patients
The genetic determinants of the host the patient could also be predictive of the severity of the disease and so does the immunological response to the COVID-19 Likewise it has been suggested that certain mutations notably the D614G mutation of the viral sequence could be associated with the infectivity of the virus
In addition to the direct role of the microbiota in the course of infection the immune characteristics specific to the host by themselves or in interaction with the microbiota could play an important role in the progression of the disease
This project focuses on the clinical characterization of COVID-19 and its evolution as well as disease management
The research focuses on 4 main areas
Characterization of the oropharyngeal and intestinal microbiota of patients with COVID-19
Characteristics of the host genotype
Immune characteristics of the host
Characteristics of the SARS-CoV-2 viral genome
For patients transferred in intensive care unit The investigators will to perform another series of samples to better characterize the evolution of microbiota during mechanical ventilation and identify factors associated with the risk of developing a ventilator-associated pneumonia
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None