- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04488510
Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: (COVAP)
Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: COVAP Study
Study Overview
Status
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
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Paris, France, 75014
- Groupe Hospitalier Paris Saint-Joseph
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Research of the bacteria responsible for nosocomial pneumonia
Time Frame: 6 months
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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.
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6 months
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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).
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6 months
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Collaborators and Investigators
Collaborators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Pathologic Processes
- Coronavirus Infections
- Coronaviridae Infections
- Nidovirales Infections
- RNA Virus Infections
- Virus Diseases
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Pneumonia, Viral
- Lung Diseases
- Disease Attributes
- Cross Infection
- Iatrogenic Disease
- COVID-19
- Healthcare-Associated Pneumonia
- Pneumonia
- Pneumonia, Ventilator-Associated
- Coinfection
Other Study ID Numbers
- COVAP
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