Trial Measuring the Clinical Impact of the FilmArray® Pneumonia Panel in Critically Ill (FA-PNEU)

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Status: Completed

Conditions: Pneumonia

Treatments: Diagnostic Test: FilmArray Pneumonia

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03943732

2019/14MAR/124 (Other Identifier)

FA-PNEU

Details and patient eligibility

About

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.

Full 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.

Enrollment: 300 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

300 participants in 2 patient groups

control

No Intervention group

Description:

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

Intervention

Experimental group

Description:

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.

Treatment:

Diagnostic Test: FilmArray Pneumonia