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Completed

NCT Number: NCT03943732

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

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.

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Key information

Conditions

Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

FilmArray Pneumonia

Diagnostic Test

FilmArray Pneumonia testing of tracheal sample

Primary outcomes

  1. Turn Around Time Treatment

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

    Turn Around Time administration of optimal antimicrobial treatment

Secondary outcomes

  1. Performances FilmArray Pneumonia

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

    Microbiological performances FA-PNEU test versus routine microbiology testing

Sponsors and collaborators

Lead sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Other

Collaborators

  • BioMérieux

Registry information

Official study title

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

Acronym: FA-PNEU

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
May 9, 2019
Registry last updated
May 17, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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