COVID-19NCT04382092
Co-infection Management in COVID-19 Critically Ill
A study testing FilmArray Pneumonia in people with COVID-19, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
International guidelines suggest the administration of empirical broad-spectrum antibiotics for suspected bacterial co-infection in COVID-19 critically ill. However, data on associated respiratory infections is rare and antimicrobial stewardship interventions promoting antibiotic savings are non-existent in this… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- FilmArray Pneumonia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteBelgium
- Study dates
- 23 Mar 2020to 24 Apr 2020
- Phase
- Interventional
- 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
Who may be able to join
- Adult patients remaining at the intensive care (SIM, SIT) of the CUSL with a confirmed COVID-19 infection
Who cannot join
- Patients from whom no respiratory sample can be obtained or
- Patients benefitting from palliative care or
- Insufficient volume of the respiratory sample after routine testing to perform the FA-PNEU test.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Co-infections in COVID-19 Critically Ill and Antibiotic Management
International guidelines suggest the administration of empirical broad-spectrum antibiotics for suspected bacterial co-infection in COVID-19 critically ill. However, data on associated respiratory infections is rare and antimicrobial stewardship interventions promoting antibiotic savings are non-existent in this context.
The main objectives of the trial are:
to evaluate the rate of co-infections among COVID-19 critically ill to evaluate the added value of a a rapid molecular diagnostic tool (FA-PNEU) to detect the presence of co-infecting pathogens in order to rapidly tailor the patient's antibiotic treatment
Read the detailed description
At the end of April 2020, the World Health Organisation reported that nearly three million people worldwide were infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) of whom 202 000 people already died from the associated disease named COVID-19. Clinical presentation varies from asymptomatic carriage to a severe respiratory infection with an acute respiratory distress syndrome and it has been calculated that approximately 5% of COVID-19 patients require intensive care. Dramatically, the reported mortality rate 28 days following admission upon the intensive care unit (ICU) is as high as 61.5%.
The 23th of March, an expert team of the Surviving Sepsis Campaign (SSC) has released a series of guidelines on the management of COVID-19 in critically ill in which they address recommendations on infection control and testing, hemodynamic control, ventilatory support and therapy. Considering the latter, the use of empiric antimicrobial/antibacterial agents is suggested among patients who have respiratory failure requiring mechanical ventilation because of suspected co-infection. Reported rates of bacterial co-infection in Influenza A patients range from 6 to 65%. It could be thought that SARS-CoV-2 destroys the respiratory epithelium in a similar way thereby facilitating bacterial invasion. SSC experts further suggest to assess for de-escalation. Rationally the adjustment to a targeted antibiotherapy requires a microbiological diagnosis of the suspected bacterial co-infection. Contemporary laboratory culture-based testing on lower respiratory tract samples requires a minimum of 24-48 hours to obtain respectively identification and antimicrobial susceptibility results. During this incompressible time interval, administration of broad-spectrum antibiotics is maintained with a risk of selecting multi-resistant bacteria potentially causing nosocomial infections. Aiming to reduce time of microbiological analysis, molecular tools have been very recently developed allowing the detection of a panel of microorganisms including bacteria and viruses directly from a lower respiratory tract sample within a few hours. Recent evaluations reported satisfying performances compared to routine microbiological methods and forecasted a substantial benefit of molecular testing in the speeded-up instauration of a targeted antibiotherapy and isolation precautions in patients with lower respiratory tract infections.
In this prospective clinical trial, the investigators performed a rapid molecular test on the initial lower respiratory sample of each COVID-19 patient admitted to ICU. The primary objective of the study was to determine the rate of co-infections in COVID-19 critically ill and the secondary objective was to measure the impact of the rapid molecular diagnostic test on the antimicrobial management of all included patients. The investigators hypothesized the rapid results of the detected pathogens will support the intensive care physician in the initiation of a targeted antibiotic treatment but also in the weaning of any antibiotherapy if all microorganisms remain undetected.
- Conditions
- COVID-19
- Being tested
- FilmArray Pneumonia
- Keywords
- COVID-19, Pneumonia, Molecular Testing, Antimicrobial stewardship, FilmArray Pneumonia plus panel
- Medical subject headings
- COVID-19, Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray PneumoniaDiagnostic test
Respiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day.
| Study group | Role | What they receive |
|---|---|---|
| Intervention COVID-19 | Experimental | Respiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day. Receives: Diagnostic Test: FilmArray Pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
% of COVID-19 co-infections
COVID-19 infections with additional bacteria/viruses identified through FA-PNEU testing
Measured: through study completion, an average of 1 month
Secondary outcomes (1)
% of antibiotic switches following FA results
The rapid FA results could allow a fast modification of the empirical antibiotherapy. This percentage will be measured.
Measured: through study completion, an average of 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 May 2020
- Study start23 Mar 2020
- Primary completion24 Apr 2020
- Study completion24 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- prospective interventional study
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Alexia VERROKEN, MD, PhD, Principal investigator, Cliniques universitaires St-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04382092
- Sponsor's protocol ID
- 2019/14MAR/124
- Status last verified
- May 2020
- First submitted
- 6 May 2020
- Last updated
- 11 May 2020
- 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 11 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Co-infections in COVID-19 Critically Ill and Antibiotic Management
- ClinicalTrials.gov ID
- NCT04382092
- Acronym / sponsor ID
- 2019/14MAR/124
- Conditions
- COVID-19
- Keywords
- COVID-19, Pneumonia, Molecular Testing, Antimicrobial stewardship, FilmArray Pneumonia plus panel
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 23 Mar 2020 (actual)
- Primary completion
- 24 Apr 2020 (actual)
- Study completion
- 24 Apr 2020 (actual)
- First posted
- 11 May 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.
International guidelines suggest the administration of empirical broad-spectrum antibiotics for suspected bacterial co-infection in COVID-19 critically ill. However, data on associated respiratory infections is rare and antimicrobial stewardship interventions promoting antibiotic savings are non-existent in this context.
The main objectives of the trial are:
to evaluate the rate of co-infections among COVID-19 critically ill to evaluate the added value of a a rapid molecular diagnostic tool (FA-PNEU) to detect the presence of co-infecting pathogens in order to rapidly tailor the patient's antibiotic treatment
Detailed description
At the end of April 2020, the World Health Organisation reported that nearly three million people worldwide were infected with the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) of whom 202 000 people already died from the associated disease named COVID-19. Clinical presentation varies from asymptomatic carriage to a severe respiratory infection with an acute respiratory distress syndrome and it has been calculated that approximately 5% of COVID-19 patients require intensive care. Dramatically, the reported mortality rate 28 days following admission upon the intensive care unit (ICU) is as high as 61.5%.
The 23th of March, an expert team of the Surviving Sepsis Campaign (SSC) has released a series of guidelines on the management of COVID-19 in critically ill in which they address recommendations on infection control and testing, hemodynamic control, ventilatory support and therapy. Considering the latter, the use of empiric antimicrobial/antibacterial agents is suggested among patients who have respiratory failure requiring mechanical ventilation because of suspected co-infection. Reported rates of bacterial co-infection in Influenza A patients range from 6 to 65%. It could be thought that SARS-CoV-2 destroys the respiratory epithelium in a similar way thereby facilitating bacterial invasion. SSC experts further suggest to assess for de-escalation. Rationally the adjustment to a targeted antibiotherapy requires a microbiological diagnosis of the suspected bacterial co-infection. Contemporary laboratory culture-based testing on lower respiratory tract samples requires a minimum of 24-48 hours to obtain respectively identification and antimicrobial susceptibility results. During this incompressible time interval, administration of broad-spectrum antibiotics is maintained with a risk of selecting multi-resistant bacteria potentially causing nosocomial infections. Aiming to reduce time of microbiological analysis, molecular tools have been very recently developed allowing the detection of a panel of microorganisms including bacteria and viruses directly from a lower respiratory tract sample within a few hours. Recent evaluations reported satisfying performances compared to routine microbiological methods and forecasted a substantial benefit of molecular testing in the speeded-up instauration of a targeted antibiotherapy and isolation precautions in patients with lower respiratory tract infections.
In this prospective clinical trial, the investigators performed a rapid molecular test on the initial lower respiratory sample of each COVID-19 patient admitted to ICU. The primary objective of the study was to determine the rate of co-infections in COVID-19 critically ill and the secondary objective was to measure the impact of the rapid molecular diagnostic test on the antimicrobial management of all included patients. The investigators hypothesized the rapid results of the detected pathogens will support the intensive care physician in the initiation of a targeted antibiotic treatment but also in the weaning of any antibiotherapy if all microorganisms remain undetected.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- prospective interventional study
| Arm | Type | Receives |
|---|---|---|
| Intervention COVID-19 | Experimental | Diagnostic Test: FilmArray PneumoniaRespiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients remaining at the intensive care (SIM, SIT) of the CUSL with a confirmed COVID-19 infection
Key exclusion criteria (3 listed)
- Patients from whom no respiratory sample can be obtained or
- Patients benefitting from palliative care or
- Insufficient volume of the respiratory sample after routine testing to perform the FA-PNEU test.
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 PneumoniaRespiratory samples are treated according to routine laboratory testing : culture, immuno assays AND molecular testing (FilmArray PNEU) of the endotracheal aspirate sample 24 hours a day. | Diagnostic test | Intervention COVID-19 |
Primary outcome
% of COVID-19 co-infections
Time frame: through study completion, an average of 1 month
COVID-19 infections with additional bacteria/viruses identified through FA-PNEU testing
1 secondary outcome
% of antibiotic switches following FA results
Time frame: through study completion, an average of 1 month
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 11 May 2020.
- 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.
Alexia VERROKEN, MD, PhD principal investigator
Cliniques universitaires St-Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FilmArray Pneumonia in people with COVID-19, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
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 1 inclusion and 3 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 11 May 2020. 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 Belgium. 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?
% of COVID-19 co-infections (time frame: through study completion, an average of 1 month). 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 11 May 2020.