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

Randomized Trial Measuring the Clinical Impact of the FilmArray® Pneumonia, a Prospective Interventional Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03943732
Acronym
FA-PNEU
Enrollment
300
Registered
2019-05-09
Start date
2019-05-27
Completion date
2020-12-31
Last updated
2022-05-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

Pneumonia, Molecular Testing, Clinical impact, FilmArray Pneumonia

Brief 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.

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.

Interventions

DIAGNOSTIC_TESTFilmArray Pneumonia

FilmArray Pneumonia testing of tracheal sample

Sponsors

BioMérieux
CollaboratorINDUSTRY
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
DIAGNOSTIC
Masking
NONE

Intervention model description

Open Randomized study, consecutive 2 weeks-period for observation group and study group

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
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

* 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.

Design outcomes

Primary

MeasureTime frameDescription
Turn Around Time Treatment48 hours from arrival of the respiratory sample at the laboratoryTurn Around Time administration of optimal antimicrobial treatment

Secondary

MeasureTime frameDescription
Performances FilmArray Pneumonia1 week from arrival of the respiratory sample at the laboratoryMicrobiological performances FA-PNEU test versus routine microbiology testing

Countries

Belgium

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026