Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:

NCT04488510 | Unknown

• 1 other identifier: COVAP
• Study Type: observational
• Target: 22
• Locations: 1 country
• Sites: 1

Brief Summary

A Respiratory infection with the SARS-CoV2 virus is associated with a major risk of viral pneumonia that can lead to respiratory distress requiring resuscitation. In the most severe forms, it may require mechanical ventilation or even lead to an acute respiratory distress syndrome with a particularly poor prognosis. The SARS-CoV2 is a single-stranded RNA virus of positive polarity and belongs to the beta genus of Coronaviruses. SARS-CoV2 is responsible for the third epidemic in less than twenty years secondary to a Coronavirus (SARS-CoV then MERS-CoV) and if the mortality associated with it is lower than that of previous strains, notably MERS-CoV, its spread is considerably big. As a result, the number of patients developing respiratory distress requiring invasive mechanical ventilation is high, with prolonged ventilation duration in these situations

Conditions

Covid19; Ventilator Associated Pneumonia; Nosocomial Pneumonia

Keywords

Pneumonia under mechanical ventilation; ICU; covid19; coronavirus; nosocomial pneumonia; bacteria

Outcome Measures

Primary Outcomes (1)

• Research of the bacteria responsible for nosocomial pneumonia

  Establishing a biobank of the bacterial agents responsible for nosocomial pneumonia acquired under mechanical ventilation in order to: better understand the particularities of the bacteria responsible and obtain the "clinical" strains for in vitro studies that will be carried out secondarily.

  6 months

Secondary Outcomes (1)

• Additional evaluations to the study

  6 months

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Patient aged over 18 years, infected by the COVID-19 with a severe form of pneumonia especially the nosocomial pneumonia acquired under mechanical ventilation.

You may qualify if:

• Patient whose age ≥ 18 years old
• French-speaking patient
• Patient whose COVID-19 infection was diagnosed by either a laboratory test, PCR or any other commercial or public health test.
• Adult acute respiratory distress syndrome according to the Berlin definition
• Pneumonia acquired under mechanical ventilation defined according to the criteria of international companies

You may not qualify if:

• Patient/family or proxy opposing participation in the study
• Patient under guardianship or curatorship
• Patient deprived of liberty
• Patient under the safeguard of justice.

Sponsors & Collaborators

• Fondation Hôpital Saint-Joseph: lead
• Centre Hospitalier Victor Dupouy: collaborator

Study Sites (1)

Groupe Hospitalier Paris Saint-Joseph

Paris, 75014, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

During the inclusion, a 4 ml citrate tube of blood in addition to the usual management assessment and aspiration of tracheal secretions will be performed at D1, D3 and D7. Tracheal aspiration is performed systematically in order to limit patient congestion and the risk of atelectasis.

MeSH Terms

Conditions

COVID-19; Pneumonia, Ventilator-Associated; Healthcare-Associated Pneumonia; Coronavirus Infections

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Cross Infection; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• François PHILLIPART, MD

  Fondation Hôpital Saint-Joseph

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 23, 2020
• First Posted: July 28, 2020
• Study Start: September 11, 2020
• Primary Completion: September 10, 2022
• Study Completion: April 30, 2023
• Last Updated: March 7, 2023

Record last verified: 2023-03

Locations

FR (1)