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

Primary Purpose

Pneumonia

Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
FilmArray Pneumonia
Sponsored by
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Pneumonia focused on measuring Pneumonia, Molecular Testing, Clinical impact, FilmArray Pneumonia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Cliniques Universitaires Saint-Luc

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

control

Intervention

Arm Description

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

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.

Outcomes

Primary Outcome Measures

Turn Around Time Treatment
Turn Around Time administration of optimal antimicrobial treatment

Secondary Outcome Measures

Performances FilmArray Pneumonia
Microbiological performances FA-PNEU test versus routine microbiology testing

Full Information

First Posted
May 8, 2019
Last Updated
May 16, 2022
Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
BioMérieux
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1. Study Identification

Unique Protocol Identification Number
NCT03943732
Brief Title
Trial Measuring the Clinical Impact of the FilmArray® Pneumonia Panel in Critically Ill
Acronym
FA-PNEU
Official Title
Randomized Trial Measuring the Clinical Impact of the FilmArray® Pneumonia, a Prospective Interventional Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 27, 2019 (Actual)
Primary Completion Date
October 29, 2020 (Actual)
Study Completion Date
December 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cliniques universitaires Saint-Luc- Université Catholique de Louvain
Collaborators
BioMérieux

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pneumonia
Keywords
Pneumonia, Molecular Testing, Clinical impact, FilmArray Pneumonia

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Model Description
Open Randomized study, consecutive 2 weeks-period for observation group and study group
Masking
None (Open Label)
Allocation
Randomized
Enrollment
300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
control
Arm Type
No Intervention
Arm Description
Respiratory samples are treated according to routine laboratory testing : culture, immuno assays
Arm Title
Intervention
Arm Type
Experimental
Arm 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.
Intervention Type
Diagnostic Test
Intervention Name(s)
FilmArray Pneumonia
Intervention Description
FilmArray Pneumonia testing of tracheal sample
Primary Outcome Measure Information:
Title
Turn Around Time Treatment
Description
Turn Around Time administration of optimal antimicrobial treatment
Time Frame
48 hours from arrival of the respiratory sample at the laboratory
Secondary Outcome Measure Information:
Title
Performances FilmArray Pneumonia
Description
Microbiological performances FA-PNEU test versus routine microbiology testing
Time Frame
1 week from arrival of the respiratory sample at the laboratory

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alexia VERROKEN
Organizational Affiliation
Cliniques universitaires St-Luc
Official's Role
Principal Investigator
Facility Information:
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
33395094
Citation
Kerneis S, Visseaux B, Armand-Lefevre L, Timsit JF. Molecular diagnostic methods for pneumonia: how can they be applied in practice? Curr Opin Infect Dis. 2021 Apr 1;34(2):118-125. doi: 10.1097/QCO.0000000000000713.
Results Reference
derived

Learn more about this trial

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

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