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

May 16, 2022 updated by: Cliniques universitaires Saint-Luc- Université Catholique de Louvain

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

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.

Study Overview

Status

Completed

Conditions

Intervention / 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 Type

Interventional

Enrollment (Actual)

300

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Bruxelles, Belgium, 1200
        • Cliniques Universitaires Saint-Luc

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
48 hours from arrival of the respiratory sample at the laboratory

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
1 week from arrival of the respiratory sample at the laboratory

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

Collaborators

BioMérieux

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 27, 2019

Primary Completion (Actual)

October 29, 2020

Study Completion (Actual)

December 31, 2020

Study Registration Dates

First Submitted

May 8, 2019

First Submitted That Met QC Criteria

May 8, 2019

First Posted (Actual)

May 9, 2019

Study Record Updates

Last Update Posted (Actual)

May 17, 2022

Last Update Submitted That Met QC Criteria

May 16, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FA-PNEU
  • 2019/14MAR/124 (Other Identifier: CEHF)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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