Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04488510
Recruitment Status : Active, not recruiting
First Posted : July 28, 2020
Last Update Posted : August 3, 2020
Sponsor:
Collaborator:
Centre Hospitalier Victor Dupouy
Information provided by (Responsible Party):
Groupe Hospitalier Paris Saint Joseph

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

Condition or disease
Covid19 Ventilator Associated Pneumonia Nosocomial Pneumonia

Detailed 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

Layout table for study information
Study Type : Observational
Actual Enrollment : 150 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: COVAP Study
Actual Study Start Date : May 6, 2020
Actual Primary Completion Date : May 6, 2020
Estimated Study Completion Date : November 30, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia




Primary Outcome Measures :
  1. Research of the bacteria responsible for nosocomial pneumonia [ Time Frame: 6 months ]
    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.


Secondary Outcome Measures :
  1. Additional evaluations to the study [ Time Frame: 6 months ]
    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).


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.


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04488510


Locations
Layout table for location information
France
Groupe Hospitalier Paris Saint-Joseph
Paris, France, 75014
Sponsors and Collaborators
Groupe Hospitalier Paris Saint Joseph
Centre Hospitalier Victor Dupouy
Layout table for additonal information
Responsible Party: Groupe Hospitalier Paris Saint Joseph
ClinicalTrials.gov Identifier: NCT04488510    
Other Study ID Numbers: COVAP
First Posted: July 28, 2020    Key Record Dates
Last Update Posted: August 3, 2020
Last Verified: July 2020
Keywords provided by Groupe Hospitalier Paris Saint Joseph:
Pneumonia under mechanical ventilation
ICU
covid19
coronavirus
nosocomial pneumonia
bacteria
Additional relevant MeSH terms:
Layout table for MeSH terms
Pneumonia, Ventilator-Associated
Healthcare-Associated Pneumonia
Coinfection
Pneumonia
Infection
Lung Diseases
Respiratory Tract Diseases
Respiratory Tract Infections
Cross Infection
Iatrogenic Disease
Disease Attributes
Pathologic Processes
Virus Diseases
Parasitic Diseases