PneumoniaFA-PNEUNCT03943732
Trial Measuring the Clinical Impact of the FilmArray® Pneumonia Panel in Critically Ill
A study testing FilmArray Pneumonia in people with Pneumonia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia
- What is being tested?
- FilmArray Pneumonia
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteBelgium
- Study dates
- 27 May 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Pneumonia
- Being tested
- FilmArray Pneumonia
- Keywords
- Pneumonia, Molecular Testing, Clinical impact, FilmArray Pneumonia
- Medical subject headings
- Pneumonia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray PneumoniaDiagnostic test
FilmArray Pneumonia testing of tracheal sample
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: FilmArray Pneumonia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Turn Around Time Treatment
Turn Around Time administration of optimal antimicrobial treatment
Measured: 48 hours from arrival of the respiratory sample at the laboratory
Secondary outcomes (1)
Performances FilmArray Pneumonia
Microbiological performances FA-PNEU test versus routine microbiology testing
Measured: 1 week from arrival of the respiratory sample at the laboratory
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2019
- Study start27 May 2019
- Primary completion29 Oct 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- More trials run by Cliniques universitaires Saint-Luc- Université Catholique de LouvainThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Open Randomized study, consecutive 2 weeks-period for observation group and study group
- Masking
- None (open label)
- Enrolment
- 300 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- BioMérieux
- Responsible party
- Sponsor
- Investigators
- Alexia VERROKEN, Principal investigator, Cliniques universitaires St-Luc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03943732
- Sponsor's protocol ID
- FA-PNEU
- Other IDs
- 2019/14MAR/124
- Acronym
- FA-PNEU
- Status last verified
- May 2022
- First submitted
- 8 May 2019
- Last updated
- 17 May 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 33395094
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Trial Measuring the Clinical Impact of the FilmArray® Pneumonia, a Prospective Interventional Trial
- ClinicalTrials.gov ID
- NCT03943732
- Acronym / sponsor ID
- FA-PNEU / FA-PNEU
- Conditions
- Pneumonia
- Keywords
- Pneumonia, Molecular Testing, Clinical impact, FilmArray Pneumonia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 300 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 27 May 2019 (actual)
- Primary completion
- 29 Oct 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 9 May 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Open Randomized study, consecutive 2 weeks-period for observation group and study group
| Arm | Type | Receives |
|---|---|---|
| control | No intervention | –Respiratory samples are treated according to routine laboratory testing : culture, immuno assays |
| Intervention | Experimental | Diagnostic Test: FilmArray PneumoniaRespiratory 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| FilmArray PneumoniaFilmArray Pneumonia testing of tracheal sample | Diagnostic test | Intervention |
Primary outcome
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
1 secondary outcome
Performances FilmArray Pneumonia
Time frame: 1 week from arrival of the respiratory sample at the laboratory
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2022.
- Derived from this study: PubMed 33395094Kerneis 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexia VERROKEN principal investigator
Cliniques universitaires St-Luc
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing FilmArray Pneumonia in people with Pneumonia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Turn Around Time Treatment (time frame: 48 hours from arrival of the respiratory sample at the laboratory). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03943732, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 May 2022; AzTrials last refreshed its copy on 8 Nov 2026.