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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/17/2021.

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

Clinicaltrials.gov identifier NCT03943732

Recruitment Status Recruiting

First Posted May 9, 2019

Last update posted May 8, 2020

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.

  • Condition or Disease:Pneumonia
  • Intervention/Treatment: Diagnostic Test: FilmArray Pneumonia
  • Phase: N/A
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 Design
  • Study Type: Interventional
  • Estimated Enrollment: 300 participants
  • Allocation: Randomized
  • Intervention Model: Sequential Assignment
  • Intervention Model Description: Open Randomized study, consecutive 2 weeks-period for observation group and study group
  • Masking: None (Open Label) ()
  • Primary Purpose: Diagnostic
  • Official Title: Randomized Trial Measuring the Clinical Impact of the FilmArray® Pneumonia, a Prospective Interventional Trial
  • Actual Study Start Date: May 2019
  • Estimated Primary Completion Date: May 2020
  • Estimated Study Completion Date: May 2020
Arms and interventions
Arm Intervention/treatment
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
Outcome Measures
  • Primary Outcome Measures: 1. 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
  • Secondary Outcome Measures: 1. 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
Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers: No

Inclusion Criteria:

- Adult patients 18 years, remaining at the intensive care of the Saint-Luc University

- Recently transferred from emergency care with Community acquired Pneumonia of grade 4

- 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.

Contacts and Locations

Contact: Alexia VERROKEN, MD, PhD +3227646766 alexia.verroken@uclouvain.be

Contact: Pierre-François LATERRE, MD, PhD pierre-françois.laterre@uclouvain.be


Cliniques Universitaires Saint-Luc

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain



Principal Investigator: Alexia VERROKEN Cliniques universitaires St-Luc

More Information
  • Responsible Party: Cliniques universitaires Saint-Luc- Université Catholique de Louvain
  • ClinicalTrials.gov Identifier: NCT03943732 History of Changes
  • Other Study ID Numbers: FA-PNEU, 2019/14MAR/124
  • First Posted: May 9, 2019 Key Record Dates
  • Last Update Posted: May 8, 2020
  • Last Verified: May 2020
  • Individual Participant
    Data (IPD) Sharing
  • Plan to Share IPD: No
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Cliniques universitaires Saint-Luc- Université Catholique de Louvain: Pneumonia
    Molecular Testing
    Clinical impact
    FilmArray Pneumonia
  • Additional relevant MeSH terms: Pneumonia