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CompletedNCT03943732FA-PNEUUpdated May 17, 2022

Trial Measuring the Clinical Impact of the FilmArray® Pneumonia Panel in Critically Ill

An interventional study of FilmArray Pneumonia in Pneumonia, sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain. Completed at 1 site in Belgium. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2022-05-17.

Sponsored by Cliniques universitaires Saint-Luc- Université Catholique de Louvain · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
300
Allocation
Randomized
Ages
18 Years and older
Sex
All
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Study summary

The objective of this study is to measure how the use of Film-Array Pneumonia (FA-PNEU) on respiratory samples of adult patients suspected of acute care pneumonia in the intensive care unit of Saint-Luc University Hospital can accelerate / improve the initiation of the optimal antibiotic treatment.

Read the detailed description

The main objective of this trial is to confirm/attest/prove the following statement:

The use of the FilmArray Pneumonia panel on respiratory samples of critically ill suspected with pneumonia, enables a faster microbiological pneumonia diagnosis and an improved therapeutic management of the patient.

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Conditions studied

  • Pneumonia

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Keywords

  • Pneumonia
  • Molecular Testing
  • Clinical impact
  • FilmArray Pneumonia
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In context

Pneumonia

2,044 studies on the registry are indexed under Pneumonia; 283 are open to participants now.

This study's enrollment of 300 is above the median of 106 across 1,247 interventional studies indexed under Pneumonia.

Browse Pneumonia studies →

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain is the lead sponsor of 342 studies on the registry; 61 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Adult patients 18 years, remaining at the intensive care of the Saint-Luc University Hospital
  • Recently transferred from emergency care with Community acquired Pneumonia of grade 4 suspicion
  • With a Ventilation acquired Pneumonia suspicion

Suspicion will be based on symptoms, clinical, biological and radiological criteria.

Exclusion criteria

Exclusion Criteria:

  • Patients from whom no respiratory sample can be obtained
  • Patients benefitting from palliative care
  • Insufficient volume of the respiratory sample after routine testing to perform the FA-PNEU test.
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Sequential assignment
Masking
None (open label)
Enrollment
300 participants (actual)

Study arms

  • No intervention
    control

    Respiratory samples are treated according to routine laboratory testing : culture, immuno assays

  • Experimental
    Intervention

    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.

    Diagnostic Test: FilmArray Pneumonia

Interventions

  • Diagnostic testFilmArray Pneumonia

    FilmArray Pneumonia testing of tracheal sample

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What researchers measure

Primary outcomes

  1. Turn Around Time Treatment

    Turn Around Time administration of optimal antimicrobial treatment

    Time frame: 48 hours from arrival of the respiratory sample at the laboratory

Secondary outcomes

  1. Performances FilmArray Pneumonia

    Microbiological performances FA-PNEU test versus routine microbiology testing

    Time frame: 1 week from arrival of the respiratory sample at the laboratory

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Study locations

1 site
  • Cliniques Universitaires Saint-Luc
    Bruxelles, 1200, Belgium
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References and documents

Publications

  • Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713. PubMed 33395094 ↗

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 17, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT03943732
Lead sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
BioMérieux
Responsible party
Sponsor
First posted
May 9, 2019
Start date
May 27, 2019
Primary completion
Oct 29, 2020
Completion
Dec 31, 2020
Last update
May 17, 2022

Study contacts

Alexia VERROKEN
principal investigator · Cliniques universitaires St-Luc

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2022. You cannot join it, but the record below documents what was studied.

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