Covid19COVAPNCT04488510
Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia:
An observational study of Covid19 and Ventilator Associated Pneumonia, run by Fondation Hôpital Saint-Joseph at 1 site in France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Covid19, Ventilator Associated Pneumonia, Nosocomial Pneumonia
- How many people
- 22 participants
- Where
- 1 siteFrance
- Study dates
- 11 Sep 2020to 30 Apr 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patient/family or proxy opposing participation in the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under the safeguard of justice.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: COVAP Study
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
Read the 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
- Keywords
- Pneumonia under mechanical ventilation, ICU, covid19, coronavirus, nosocomial pneumonia, bacteria
- Medical subject headings
- COVID-19, Pneumonia, Ventilator-Associated, Healthcare-Associated Pneumonia, Coronavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (1)
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).
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2020
- Study start11 Sep 2020
- Primary completion10 Sep 2022
- Study completion30 Apr 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fondation Hôpital Saint-Joseph
- Sponsor type
- University, hospital or other
- Collaborators
- Centre Hospitalier Victor Dupouy
- Responsible party
- Sponsor
- Investigators
- François PHILLIPART, MD, Principal investigator, Fondation Hôpital Saint-Joseph
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04488510
- Sponsor's protocol ID
- COVAP
- Acronym
- COVAP
- Status last verified
- Mar 2023
- First submitted
- 23 Jul 2020
- Last updated
- 7 Mar 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pathogens Involved in Secondary Infections During Severe Forms of Covid-19 Pneumonia: COVAP Study
- ClinicalTrials.gov ID
- NCT04488510
- Acronym / sponsor ID
- COVAP / COVAP
- Keywords
- Pneumonia under mechanical ventilation, ICU, covid19, coronavirus, nosocomial pneumonia, bacteria
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Fondation Hôpital Saint-JosephUniversity, hospital or other
- Collaborators
- Centre Hospitalier Victor Dupouy
- Study start
- 11 Sep 2020 (actual)
- Primary completion
- 10 Sep 2022 (actual)
- Study completion
- 30 Apr 2023 (estimated)
- First posted
- 28 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
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 design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- Patient/family or proxy opposing participation in the study
- Patient under guardianship or curatorship
- Patient deprived of liberty
- Patient under the safeguard of justice.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
1 secondary outcome
Additional evaluations to the study
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
François PHILLIPART, MD principal investigator
Fondation Hôpital Saint-Joseph
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Covid19 and Ventilator Associated Pneumonia, run by Fondation Hôpital Saint-Joseph at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Research of the bacteria responsible for nosocomial pneumonia (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Mar 2023.