SARS-CoV2 InfectionECOLCOVIDNCT05089968
Ventilation Associated Pneumonia and Covid-19
An observational study of SARS-CoV2 Infection and Ventilator Associated Pneumonia, run by Centre Hospitalier Universitaire de Nīmes at 1 site in France.
Trial summary
In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- SARS-CoV2 Infection, Ventilator Associated Pneumonia, Ards
- How many people
- 268 participants
- Where
- 1 siteFrance
- Study dates
- 24 Jan 2020to 8 Jan 2021
- 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: Patients over 18 years old with a SARS-CoV-2 infection confirmed by positive PCR tests of nasopharyngeal or respiratory secretion samples. In addition, patients included presented a healthcare associated pneumonia according to SFAR(French Society of Anesthesia and Intensive Care) recommendations and based on criteria adapted from the European Centre for Disease Prevention and Control (ECDC) recommendations. Patients who refused their data use were excluded.
Who may be able to join
- Age > 18 years
- Positive SARS-Cov-2 polymerase chain reaction (PCR)
- healthcare associated pneumonia
- Exclusion Criteria : Patient opposition to participate to the study
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ventilator-associated Pneumonia Ecology Comparison in a French ICU Center NIMES Between First and Second Wave of COVID-19 : a Retrospective Monocentric Descriptive Study
In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Since the beginning of the pandemic, Standard of care have evolved with new data. The prevalence of these VAPs seems significantly higher in the population of patients with ARDS COVID-19 (40-50%) and their ecology seems to have evolved over time, particularly in terms of bacterial resistance. Investigators want to describe and compare this evolution of bacterial and fungal ecology as well as identify potential risk factors that may be associated with these changes in ecology during different waves.
- Conditions
- SARS-CoV2 Infection, Ventilator Associated Pneumonia, Ards, COVID-19
- Keywords
- Intensive care Unit, multidrug resistance, COVID 19 ARDS, ventilator associated pneumonia, SARS-CoV2 Infection
- Medical subject headings
- COVID-19, Pneumonia, Ventilator-Associated, Acute Lung Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patient from the first wave of COVID-19 | 57 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 1st wave from January 24, 2020 to July 10, 2020 | |
| Patient from the Second wave of COVID-19 | 211 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 2nd wave from July 11, 2020 to January 8, 2021 |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAP ecological difference between the first and second waves of COVID
Proportion of patients admitted to critical care with documented multidrug-resistant bacteria (MDR) VAP in Covid-19 wave 1 and 2
Measured: January 2020 to January 2021
Secondary outcomes (7)
proportion of fungal co-infections
Comparison of the proportion of patients with a fungal infection during the 1st and 2nd wave
Measured: January 2020 to January 2021
duration of mechanical ventilation
Number of days under mechanical ventilations
Measured: Day 28
number of days of organ failure
number of days between first organ failure and no organ failure (discharge from intensive care)
Measured: Day 28
Mortality
proportion of patients deceased at day 28
Measured: Day 28
proportion of patients treated with corticosteroid therapy
proportion of patients treated with corticosteroid therapy
Measured: Day 28
probabilistic antibiotic therapy at admission
probabilistic antibiotic therapy prescribed at admission
Measured: Day 1
antiviral treatment
proportion of patients treated with antiviral treatment
Measured: Day 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start24 Jan 2020
- Primary completion8 Jan 2021
- Study completion8 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SARS-CoV2 InfectionStudies 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 268 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire de Nīmes
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire ROGER, MD, PhD, Principal investigator, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089968
- Sponsor's protocol ID
- LOCAL/2021/LC-01
- Acronym
- ECOLCOVID
- Status last verified
- Oct 2021
- First submitted
- 21 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ventilator-associated Pneumonia Ecology Comparison in a French ICU Center NIMES Between First and Second Wave of COVID-19 : a Retrospective Monocentric Descriptive Study
- ClinicalTrials.gov ID
- NCT05089968
- Acronym / sponsor ID
- ECOLCOVID / LOCAL/2021/LC-01
- Conditions
- SARS-CoV2 Infection, Ventilator Associated Pneumonia, Ards, COVID-19
- Keywords
- Intensive care Unit, multidrug resistance, COVID 19 ARDS, ventilator associated pneumonia, SARS-CoV2 Infection
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 268 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 24 Jan 2020 (actual)
- Primary completion
- 8 Jan 2021 (actual)
- Study completion
- 8 Jan 2021 (actual)
- First posted
- 22 Oct 2021 (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.
In December 2019, a new pandemic emerged, the COVID-19 disease caused by a SARS-Cov-2 virus. One of the most common symptoms of COVID-19 is mainly respiratory failure and patients requires assistance by mechanical ventilation. Ventilator-associated pneumonia (VAP) is a risk of this assistance. Since the beginning of the pandemic, Standard of care have evolved with new data. The prevalence of these VAPs seems significantly higher in the population of patients with ARDS COVID-19 (40-50%) and their ecology seems to have evolved over time, particularly in terms of bacterial resistance. Investigators want to describe and compare this evolution of bacterial and fungal ecology as well as identify potential risk factors that may be associated with these changes in ecology during different waves.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patient from the first wave of COVID-19 | – | –57 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 1st wave from January 24, 2020 to July 10, 2020 |
| Patient from the Second wave of COVID-19 | – | –211 Patients hospitalized in intensive care unit for pneumonia related to a Sars-Cov2 infection who required mechanical ventilatory support and developed microbiologically documented ventilator associated pneumonia during the 2nd wave from July 11, 2020 to January 8, 2021 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients over 18 years old with a SARS-CoV-2 infection confirmed by positive PCR tests of nasopharyngeal or respiratory secretion samples. In addition, patients included presented a healthcare associated pneumonia according to SFAR(French Society of Anesthesia and Intensive Care) recommendations and based on criteria adapted from the European Centre for Disease Prevention and Control (ECDC) recommendations. Patients who refused their data use were excluded.
Key inclusion criteria (4 listed)
- Age > 18 years
- Positive SARS-Cov-2 polymerase chain reaction (PCR)
- healthcare associated pneumonia
- Exclusion Criteria : Patient opposition to participate to the study
Key exclusion criteria (0 listed)
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
VAP ecological difference between the first and second waves of COVID
Time frame: January 2020 to January 2021
Proportion of patients admitted to critical care with documented multidrug-resistant bacteria (MDR) VAP in Covid-19 wave 1 and 2
7 secondary outcomes
proportion of fungal co-infections
Time frame: January 2020 to January 2021
duration of mechanical ventilation
Time frame: Day 28
number of days of organ failure
Time frame: Day 28
Mortality
Time frame: Day 28
proportion of patients treated with corticosteroid therapy
Time frame: Day 28
probabilistic antibiotic therapy at admission
Time frame: Day 1
antiviral treatment
Time frame: Day 28
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Claire ROGER, MD, PhD principal investigator
Centre Hospitalier Universitaire de Nīmes
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 SARS-CoV2 Infection and Ventilator Associated Pneumonia, run by Centre Hospitalier Universitaire de Nīmes 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 4 inclusion and 0 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: finished, as of the sponsor's last update on 22 Oct 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
VAP ecological difference between the first and second waves of COVID (time frame: January 2020 to January 2021). 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 22 Oct 2021; AzTrials last refreshed its copy on 31 Oct 2026.