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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Pneumonia

Intervention / Treatment
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* Diagnostic Test: FilmArray Pneumonia


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Open Randomized study, consecutive 2 weeks-period for observation group and study group
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>Respiratory samples are treated according to routine laboratory testing : culture, immuno assays | |
| Experimental: Intervention<br>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<br>* FilmArray Pneumonia testing of tracheal sample<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Turn Around Time Treatment | Turn Around Time administration of optimal antimicrobial treatment | 48 hours from arrival of the respiratory sample at the laboratory | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performances FilmArray Pneumonia | Microbiological performances FA-PNEU test versus routine microbiology testing | 1 week from arrival of the respiratory sample at the laboratory | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pneumonia, Molecular Testing, Clinical impact, FilmArray Pneumonia