Infectious DiseaseFAP-REANCT04453540
FilmArray and Management of ICU Patients With Pneumonia in the Covid-19 Context
An observational study of Infectious Disease and Pneumonia, run by Central Hospital, Nancy, France.
Trial summary
The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease. During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria… Read more about this study
- Who is it for?
- Ages 18 to 100 years
- Conditions the study is for
- Infectious Disease, Pneumonia, Molecular Diagnosis
- What is being tested?
- FilmArray PCR on respiratory samples
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- 1 Jul 2020to 30 Aug 2020
- Phase
- Observational
- 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 to 100 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients followed in ICU at the hospitals of Nancy and Reims for severe respiratory diseases during the first half of 2020
Who may be able to join
- Patients > 18 years affiliated to a social security system
- Patients who have received complete information about the research and who have not objected to the use of its data
- Patients with suspected SARS-Cov-2 infection
- Patients for which a FilmArray test has been realized on its respiratory samples between 1st of March and 1st of July 2020.
Who cannot join
- None
About this study
Official title: Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.
The research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease.
During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods.
In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.
- Being tested
- FilmArray PCR on respiratory samples
- Medical subject headings
- Communicable Diseases, Pneumonia, COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray PCR on respiratory samplesDiagnostic test
Molecular test performed on respiratory samples realized for microbiological routine testing as part of the care
What is being measured
The primary outcome is the main question the study is designed to answer.
Therapeutic decision
Antibiotic prescription modification following the FilmArray results as:
- No prescription
- No change in antibiotic utilization
- Antibiotic initiation
- Antibiotic escalation
- Antibiotic de-escalation
- Antibiotic discontinuation
Measured: 24 h following the FilmArray results
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2020
- Study start1 Jul 2020 (estimated)
- Primary completion30 Aug 2020 (estimated)
- Study completion30 Aug 2020 (estimated)
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 Infectious DiseaseStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Collaborators
- Reims University hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04453540
- Sponsor's protocol ID
- 2020PI101
- Acronym
- FAP-REA
- Status last verified
- Jun 2020
- First submitted
- 30 Jun 2020
- Last updated
- 1 Jul 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Novy E, Goury A, Thivilier C, Guillard T, Alauzet C. Algorithm for rational use of Film Array Pneumonia Panel in bacterial coinfections of critically ill ventilated COVID-19 patients. Diagn Microbiol Infect Dis. 2021 Nov;101(3):115507. doi: 10.1016/j.diagmicrobio.2021.115507. Epub 2021 Jul 23.
PubMed 34364096
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of the Syndromic PCR System FilmArray on Management of ICU Patients With Severe Pulmonary Disease in the Context of the Covid-19 Pandemic.
- ClinicalTrials.gov ID
- NCT04453540
- Acronym / sponsor ID
- FAP-REA / 2020PI101
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Collaborators
- Reims University hospital
- Study start
- 1 Jul 2020 (estimated)
- Primary completion
- 30 Aug 2020 (estimated)
- Study completion
- 30 Aug 2020 (estimated)
- First posted
- 1 Jul 2020 (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 research aims to determine the impact of a syndromic mutiplex PCR assay (FilmArray) on the management of patients hospitalized in ICU for severe respiratory disease.
During the SARS-CoV-2 outbreak, the diagnosis of pneumonia has become considerably more complex as the biological, radiological and clinical criteria of covid-19 interfere with the standard criteria for the diagnosis of severe respiratory diseases. Moreover, patients with COVID-19 are at higher risk of developing other associated infections and thus, patients have therefore often been treated with antibiotics, adequately or not, due to difficulty to quickly identify the etiology of their symptoms with conventional methods.
In order to improve their treatment, both diagnostic and therapeutic, we set up a new syndromic molecular test in our laboratories to accelerate and improve the pneumonia management and antibiotic stewardship. This research will include 100 to 150 adult patients hospitalized in ICU during the first half of 2020. It will take place within the Nancy University Hospital and the Reims University Hospital, France.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients followed in ICU at the hospitals of Nancy and Reims for severe respiratory diseases during the first half of 2020
Key inclusion criteria (4 listed)
- Patients > 18 years affiliated to a social security system
- Patients who have received complete information about the research and who have not objected to the use of its data
- Patients with suspected SARS-Cov-2 infection
- Patients for which a FilmArray test has been realized on its respiratory samples between 1st of March and 1st of July 2020.
Key exclusion criteria (1 listed)
- None
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 PCR on respiratory samplesMolecular test performed on respiratory samples realized for microbiological routine testing as part of the care | Diagnostic test | – |
Primary outcome
Therapeutic decision
Time frame: 24 h following the FilmArray results
Antibiotic prescription modification following the FilmArray results as: * No prescription * No change in antibiotic utilization * Antibiotic initiation * Antibiotic escalation * Antibiotic de-escalation * Antibiotic discontinuation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2020.
- Derived from this study: PubMed 34364096Novy E, Goury A, Thivilier C, Guillard T, Alauzet C. Algorithm for rational use of Film Array Pneumonia Panel in bacterial coinfections of critically ill ventilated COVID-19 patients. Diagn Microbiol Infect Dis. 2021 Nov;101(3):115507. doi: 10.1016/j.diagmicrobio.2021.115507. Epub 2021 Jul 23.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Infectious Disease and Pneumonia, run by Central Hospital, Nancy, France.
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 1 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: status not confirmed, as of the sponsor's last update on 1 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Therapeutic decision (time frame: 24 h following the FilmArray results). 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 NCT04453540, 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 1 Jul 2020.