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

Not Applicable

Completed

• Conditions: Pneumonia
• Interventions: Diagnostic Test: FilmArray Pneumonia

• Registration Number: NCT03943732
• Lead Sponsor: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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.

Study Timeline

• Study First Submitted: 2019-05-08
• Study First Submitted QC: 2019-05-08
• Study First Posted: 2019-05-09
• Study Start: 2019-05-27
• Primary Completion: 2020-10-29
• Study Completion: 2020-12-31
• Status Verified: 2022-05
• Last Update Submitted: 2022-05-16
• Last Update Posted: 2022-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 300

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Intervention	FilmArray Pneumonia	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.

Primary Outcome Measures

Name	Time	Method
Turn Around Time Treatment	48 hours from arrival of the respiratory sample at the laboratory	Turn Around Time administration of optimal antimicrobial treatment

Secondary Outcome Measures

Name	Time	Method
Performances FilmArray Pneumonia	1 week from arrival of the respiratory sample at the laboratory	Microbiological performances FA-PNEU test versus routine microbiology testing

Trial Locations

Locations (1)

Cliniques Universitaires Saint-Luc; 🇧🇪 Bruxelles, Belgium