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

Covid19 Clinical Trial

— COVAP  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04488510
• Other study ID #: COVAP
• Status: Active, not recruiting
• Start date: September 11, 2020
• Est. completion date: April 30, 2023

Study information

• Verified date: March 2023
• Source: Groupe Hospitalier Paris Saint Joseph
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

Description:

Patients requiring invasive mechanical ventilation are at risk of secondary, nosocomial, a hospitalization in the ICU service and can affect up to 40% of ventilated patients. The occurrence of ventilator-associated pneumonia is associated with an increase in the duration of mechanical ventilation and its effect on mortality remains uncertain under general conditions. The mechanisms underlying the occurrence of lower respiratory infection during invasive mechanical ventilation are numerous, depending for the most part on two distinct elements: the occurrence of transcolonisation, which will secondarily promote colonisation of the lower respiratory tract, and the modification of the competence of the immune system in its response to aggression by microbial agents whose pathogenicity is highly variable.

Throughout the infection by SARS-CoV2, the theoretical risk of secondary respiratory infection during mechanical ventilation is important due to the intrication of three concomitant phenomena: direct pulmonary aggression, which will alter the functionality of local immunity, the "cytokinic storm", responsible for the severity of the respiratory picture that motivated intubation and the need for mechanical ventilation leading inevitably to transcolonisation. Despite all of these pathophysiological arguments, very little data are available on the possibility of secondary low respiratory tract infection occurring during SARS-CoV2 infection and more generally during Coronarivus infections. even though all of these elements are well known and widely studied, very little data are currently available on the potential interaction between Coronaviruses and bacteria. The importance of this issue is very significant as recent observations tend to show a relative rarity of the occurrence of secondary lung infections during mechanical ventilation and the population of smokers, subject to chronic obstructive bronchitis (usually particularly susceptible to bacterial superinfections), does not appear to be more affected than that of non-smokers although the current data are very partial.

The research is prospective, non interventional study that involves patients suffering from another severe form a COVID-19 infection: the nosocomial pneumonia under mechanical ventilation

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 22
• Est. completion date: April 30, 2023
• Est. primary completion date: September 10, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Patient/family or proxy opposing participation in the study

• Patient under guardianship or curatorship

• Patient deprived of liberty

• Patient under the safeguard of justice.

Related Conditions & MeSH terms

• Coinfection
• COVID-19
• Covid19
• Healthcare-Associated Pneumonia
• Nosocomial Pneumonia
• Pneumonia
• Pneumonia, Ventilator-Associated
• Ventilator Associated Pneumonia

Locations

Country	Name	City	State
France	Groupe Hospitalier Paris Saint-Joseph	Paris

Sponsors (2)

Lead Sponsor	Collaborator
Groupe Hospitalier Paris Saint Joseph	Centre Hospitalier Victor Dupouy

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Additional evaluations to the study	Evaluation of the adhesion properties to the bronchial epithelium (LPS peculiarities of Gram-negative bacteria, the interaction with the virus in in vitro models and the different molecules of interest in the collected bronchial secretions).	6 months