An observational study in Covid19, sponsored by Assistance Publique - Hôpitaux de Paris. Status unknown at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-06-24.
Sponsored by Assistance Publique - Hôpitaux de Paris · Observational
Patients hospitalized for COVID-19 may need intensive care (e.g. 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.
Patients hospitalized for COVID-19 may need intensive care (e.g. mechanical ventilation) during hospitalization. Some risk factors are already known (e.g. 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:
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.
7,640 studies on the registry are indexed under COVID-19; 488 are open to participants now.
This study's planned enrollment of 200 is below the median of 261 across 3,136 observational studies indexed under COVID-19.
Browse COVID-19 studies →Assistance Publique - Hôpitaux de Paris is the lead sponsor of 3,505 studies on the registry; 1,006 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adult patient with documented SARS-CoV-2 infection requiring hospitalization.
Exclusion Criteria:
Other: oropharyngeal and intestinal microbiota · Other: host genotype · Other: host immune factors · Other: viral sequence
analysis of oropharyngeal and intestinal microbiota
analysis of a part of host genotype
analysis of host immune factors
analysis of viral sequence
Identify risk factors associated with severe forms of COVID-19 requiring transfer to ICU
The main endpoint is the indication of worsening of the general condition requiring transfer to ICU
Time frame: day 14
Link between the composition of the gut microbiota and admission to intensive care
Composition of the gut microbiota on admission to intensive care to predict the outcome of severe COVID-19 in patients transferred to the ICU (subgroup analysis)
Time frame: 3 months
Predictive performance of semi-quantitative culture and rapid metagenomic evaluation
Predictive performance of semi-quantitative culture and rapid metagenomic evaluation of the oropharyngeal microbiota to predict the occurrence of VAP in patients admitted to an ICU and mechanically ventilated (subgroup analysis).
Time frame: 3 months
Plan to share: Undecided
No publications or documents are linked to this record.
This study is status unknown, as verified in Mar 2022. You cannot join it, but the record below documents what was studied.
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Assistance Publique - Hôpitaux de Paris