SARS-CoV2 InfectionCOVIDARRAYNCT05076240
FilmArray® and Management of Ventilator Associated Pneumonia in COVID-19 ARDS
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
Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%. 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
- What is being tested?
- FilmArray® analysis
- Type of treatment
- Surgery or procedure
- How many people
- 98 participants
- Where
- 1 siteFrance
- Study dates
- 27 Mar 2021to 30 Apr 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 of 18 years old and more, hospitalized in intensive care between 27th March 2020 and April 2021 for COVID-19 acute respiratory distress syndrome, declaring a Ventilator Associated Pneumonia diagnosed by culture and having multiplex PCR analysis FilmArray®.
Who may be able to join
- Age ≥ 18 yers
- COVID-19 acute respiratory distress syndrome hospitalization
- affected Ventilator Associated Pneumonia
- having multiplex PCR analysis FilmArray®
- 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: Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS
Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%.
VAPs complicate about 40-50% of COVID-19 acute respiratory distress syndrome (ARDS) and the mortality would be twice higher.
Read more
Thus, in this context of the COVID-19 pandemic, this represents a considerable rate of patients.
Unfortunately, the risk factors for VAPs are poorly understood and the bacterial ecology varies around the world. Also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care.
New microbiological rapid diagnostic techniques have appeared in recent years, among them the FilmArray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics.
This technique has been studied in acute community pneumonia but has not been validated in VAP and even less during the COVID-19 period.
Investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using FilmArray® would improve the relevance of the antibiotic treatment.
The aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of Ventilator Associated Pneumonia during COVID-19 acute respiratory distress syndrome before an interventional study.
- Conditions
- SARS-CoV2 Infection, Ventilator Associated Pneumonia, Ards, COVID-19
- Being tested
- FilmArray® analysis
- Keywords
- FilmARRAY, ARDS, COVID 19, ventilator associated pneumonia, DIAGNOSTIC
- Medical subject headings
- COVID-19, Pneumonia, Ventilator-Associated, Acute Lung Injury, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray® analysisProcedure or surgery
FilmArray® multiplex PCR analysis to diagnose ventilator associated pneumonia in COVID-19 ARDS
| Study group | Role | What they receive |
|---|---|---|
| Adults with ventilator associated pneumonia in COVID-19 ARDS | Patient hospitalized in intensive care unit for acute respiratory distress related to a Sars-Cov2 infection having contracted ventilator associated pneumonia. The diagnosis was made by culture but also with a FilmArray® multiplex PCR analysis. Receives: Procedure: FilmArray® analysis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of FilmArray® on the adaptation of antibiotic therapy
Proportion of patients for whom the FilmArray® technique induces an adaptation of antibiotic therapy
Measured: Day 7
Secondary outcomes (3)
Diagnostic Performance
Diagnostic performance of FilmArray® in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID 19 (evaluated by FilmArray®-culture diagnostic concordance
Measured: Day 7
Bacterial ecology
Description of the bacterial species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19
Measured: Day 7
Fungal ecology
Description of the fungal species and proportions in ventilator-associated pneumonia during severe acute respiratory syndrome related to COVID-19
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Oct 2021
- Study start27 Mar 2021
- Primary completion30 Apr 2021
- Study completion30 Apr 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.
- More trials run by Centre Hospitalier Universitaire de NīmesThe sponsor's other registered studies.
- 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
- 98 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, Study director, Centre Hospitalier Universitaire de Nīmes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05076240
- Sponsor's protocol ID
- LOCAL/2021/LD-01
- Acronym
- COVIDARRAY
- Status last verified
- Oct 2021
- First submitted
- 8 Oct 2021
- Last updated
- 13 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 13 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the FilmArray® Test on the Management of Ventilator Associated Pneumonia in COVID-19 ARDS
- ClinicalTrials.gov ID
- NCT05076240
- Acronym / sponsor ID
- COVIDARRAY / LOCAL/2021/LD-01
- Conditions
- SARS-CoV2 Infection, Ventilator Associated Pneumonia, Ards, COVID-19
- Keywords
- FilmARRAY, ARDS, COVID 19, ventilator associated pneumonia, DIAGNOSTIC
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 98 participants (actual)
- Lead sponsor
- Centre Hospitalier Universitaire de NīmesUniversity, hospital or other
- Study start
- 27 Mar 2021 (actual)
- Primary completion
- 30 Apr 2021 (actual)
- Study completion
- 30 Apr 2021 (actual)
- First posted
- 13 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.
Ventilator Associated Pneumonia (VAPs) are a very common side effect in intensive care units. They are the leading causes of nosocomial infections and excess mortality in intensive care units: associated with a controversial death rate of around 13%.
VAPs complicate about 40-50% of COVID-19 acute respiratory distress syndrome (ARDS) and the mortality would be twice higher.
Thus, in this context of the COVID-19 pandemic, this represents a considerable rate of patients.
Unfortunately, the risk factors for VAPs are poorly understood and the bacterial ecology varies around the world. Also, facing a high prevalence of multi-resistant bacteria in this population, the choice of probabilistic antibiotic therapy is complex and represents a considerable impact for care.
New microbiological rapid diagnostic techniques have appeared in recent years, among them the FilmArray® seems to present interesting diagnostic performances with the ability to detects resistance to antibiotics.
This technique has been studied in acute community pneumonia but has not been validated in VAP and even less during the COVID-19 period.
Investigators decide to conduct this study to investigate if the early identification of the pathogens and their mechanism of resistance using FilmArray® would improve the relevance of the antibiotic treatment.
The aim of this project is to evaluate the contribution of a rapid diagnostic technique to the management of Ventilator Associated Pneumonia during COVID-19 acute respiratory distress syndrome before an interventional study.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with ventilator associated pneumonia in COVID-19 ARDS | – | Procedure: FilmArray® analysisPatient hospitalized in intensive care unit for acute respiratory distress related to a Sars-Cov2 infection having contracted ventilator associated pneumonia. The diagnosis was made by culture but also with a FilmArray® multiplex PCR analysis. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients of 18 years old and more, hospitalized in intensive care between 27th March 2020 and April 2021 for COVID-19 acute respiratory distress syndrome, declaring a Ventilator Associated Pneumonia diagnosed by culture and having multiplex PCR analysis FilmArray®.
Key inclusion criteria (5 listed)
- Age ≥ 18 yers
- COVID-19 acute respiratory distress syndrome hospitalization
- affected Ventilator Associated Pneumonia
- having multiplex PCR analysis FilmArray®
- 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.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilmArray® analysisFilmArray® multiplex PCR analysis to diagnose ventilator associated pneumonia in COVID-19 ARDS | Procedure or surgery | Adults with ventilator associated pneumonia in COVID-19 ARDS |
Primary outcome
Impact of FilmArray® on the adaptation of antibiotic therapy
Time frame: Day 7
Proportion of patients for whom the FilmArray® technique induces an adaptation of antibiotic therapy
3 secondary outcomes
Diagnostic Performance
Time frame: Day 7
Bacterial ecology
Time frame: Day 7
Fungal ecology
Time frame: Day 7
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 13 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 study director
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 5 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 13 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?
Impact of FilmArray® on the adaptation of antibiotic therapy (time frame: Day 7). 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 13 Oct 2021.