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At Bolder Science, we want your clinical trial search experience to be the best it can be. Complete the following prompts to easily find the trials you are interested in and see trials recruiting near you. You can adjust these selections in your dashboard after creating your account.

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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

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.

Contacts and Locations

Contacts

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

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

Locations

Belgium
Cliniques Universitaires Saint-Luc
Bruxelles

Sponsors and Collaborators

Cliniques universitaires Saint-Luc- Université Catholique de Louvain

BioMérieux

Investigators

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
    Statement:

  • 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