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

NCT03943732 | Completed

• 2 other identifiers: FA-PNEU2019/14MAR/124
• Study Type: interventional
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Keywords

Pneumonia; Molecular Testing; Clinical impact; FilmArray Pneumonia

Outcome Measures

Primary Outcomes (1)

• Turn Around Time Treatment

  Turn Around Time administration of optimal antimicrobial treatment

  48 hours from arrival of the respiratory sample at the laboratory

Secondary Outcomes (1)

• Performances FilmArray Pneumonia

  1 week from arrival of the respiratory sample at the laboratory

Study Arms (2)

control

NO INTERVENTION

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

Intervention

EXPERIMENTAL

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

Interventions

FilmArray Pneumonia DIAGNOSTIC_TEST

FilmArray Pneumonia testing of tracheal sample

Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cliniques universitaires Saint-Luc- Université Catholique de Louvain: lead
• BioMérieux: collaborator

Study Sites (1)

Cliniques Universitaires Saint-Luc

Brussels, 1200, Belgium

Location

Related Publications (1)

• 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.

  PMID: 33395094 DERIVED

MeSH Terms

Conditions

Pneumonia

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Lung Diseases; Respiratory Tract Diseases

Study Officials

• Alexia VERROKEN

  Cliniques universitaires St-Luc

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Open Randomized study, consecutive 2 weeks-period for observation group and study group

Study Record Dates

• First Submitted: May 8, 2019
• First Posted: May 9, 2019
• Study Start: May 27, 2019
• Primary Completion: October 29, 2020
• Study Completion: December 31, 2020
• Last Updated: May 17, 2022

Record last verified: 2022-05

Data Sharing

• IPD Sharing: Will not share

Locations

BE (1)