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NCT03943732 Clinical Trial

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

Pneumonia Clinical Trial

— FA-PNEU  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03943732
Other study ID # FA-PNEU
Secondary ID 2019/14MAR/124
Status Completed
Phase N/A
First received
Last updated
Start date May 27, 2019
Est. completion date December 31, 2020

Study information
Verified date May 2022
Source Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 300
Est. completion date December 31, 2020
Est. primary completion date October 29, 2020
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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

Related Conditions & MeSH terms

Intervention

Diagnostic Test:
• FilmArray Pneumonia
FilmArray Pneumonia testing of tracheal sample

Locations
Country Name City State
Belgium Cliniques Universitaires Saint-Luc Bruxelles

Sponsors (2)
Lead Sponsor Collaborator
Cliniques universitaires Saint-Luc- Université Catholique de Louvain BioMérieux

Country where clinical trial is conducted

Belgium, 

Outcome
Type Measure Description Time frame Safety issue
Primary Turn Around Time Treatment Turn Around Time administration of optimal antimicrobial treatment 48 hours from arrival of the respiratory sample at the laboratory
Secondary Performances FilmArray Pneumonia Microbiological performances FA-PNEU test versus routine microbiology testing 1 week from arrival of the respiratory sample at the laboratory
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