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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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.

Belgium1 site
  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

Other trials in Belgium

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 groups in NCT04382092
Study groupRoleWhat they receive
Intervention COVID-19ExperimentalRespiratory 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.

  1. % 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)
  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.

  1. First posted11 May 2020
  2. Study start23 Mar 2020
  3. Primary completion24 Apr 2020
  4. Study completion24 Apr 2020

Resources

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)
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

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.

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