SepticemiaSEPSIS2016NCT03943719
Clinical Impact of the FilmArray Blood Culture Identification Panel Performed on Positive Blood Cultures From Intensive Care Patients With Septicemia
An observational study of Septicemia, run by Cliniques universitaires Saint-Luc- Université Catholique de Louvain at 1 site in Belgium.
Trial summary
Molecular testing is a largely validated approach allowing rapid identification of positive blood cultures. However, due to its high cost and its limited information on susceptibility, it is considered as an add-on technique reserved for specific patient populations. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Septicemia
- What is being tested?
- FilmArray blood culture identification panel
- How many people
- 139 participants
- Where
- 1 siteBelgium
- Study dates
- 1 Mar 2017to 31 Aug 2018
- How long will I take part?
- 1 Day
- 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 years and older
- All sexes
- Adult, Older adult
Study population: adult intensive care unit patients with positive blood cultures
Who may be able to join
- adult intensive care unit patients with positive blood cultures
Who cannot join
- palliative care patients
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Impact of a Rapid Molecular Identification Test on Positive Blood Cultures From Critically Ill With Bacteremia: a Pre-post Intervention Study
Molecular testing is a largely validated approach allowing rapid identification of positive blood cultures. However, due to its high cost and its limited information on susceptibility, it is considered as an add-on technique reserved for specific patient populations. In our study, we specifically evaluated molecular testing in a critical care setting and measured its impact on the therapeutic management of critically ill with positive blood cultures. Through the analysis of 110 positive blood culture episodes included in both pre- and post intervention period, we measured a drastic 14h-reduction of the time to administration of the optimal antimicrobial treatment with the use of the molecular approach.
- Conditions
- Septicemia
- Being tested
- FilmArray blood culture identification panel
- Keywords
- FilmArray, bacteremia, septicemia, clinical impact, molecular testing, identification, positive blood culture, optimal antimicrobial treatment
- Medical subject headings
- Sepsis, Bacteremia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
FilmArray blood culture identification panelDiagnostic test
FilmArray blood culture identification panel is performed 24 hours on 24hours and 7 days a week on positive blood cultures to accelerate pathogens detection
What is being measured
The primary outcome is the main question the study is designed to answer.
Turn Around Time to optimal treatment of septicemia
Time in minutes
Measured: From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours)
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 start1 Mar 2017
- Primary completion31 Dec 2017
- Study completion31 Aug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepticemiaStudies 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
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 139 participants (actual)
- Target duration
- 1 Day
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
- NCT03943719
- Sponsor's protocol ID
- SEPSIS2016
- Other IDs
- 2016/19SEP/401
- Acronym
- SEPSIS2016
- Status last verified
- May 2019
- First submitted
- 8 May 2019
- Last updated
- 9 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of a Rapid Molecular Identification Test on Positive Blood Cultures From Critically Ill With Bacteremia: a Pre-post Intervention Study
- ClinicalTrials.gov ID
- NCT03943719
- Acronym / sponsor ID
- SEPSIS2016 / SEPSIS2016
- Conditions
- Septicemia
- Keywords
- FilmArray, bacteremia, septicemia, clinical impact, molecular testing, identification, positive blood culture, optimal antimicrobial treatment
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 139 participants (actual)
- Lead sponsor
- Cliniques universitaires Saint-Luc- Université Catholique de LouvainUniversity, hospital or other
- Collaborators
- BioMérieux
- Study start
- 1 Mar 2017 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Aug 2018 (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.
Molecular testing is a largely validated approach allowing rapid identification of positive blood cultures. However, due to its high cost and its limited information on susceptibility, it is considered as an add-on technique reserved for specific patient populations. In our study, we specifically evaluated molecular testing in a critical care setting and measured its impact on the therapeutic management of critically ill with positive blood cultures. Through the analysis of 110 positive blood culture episodes included in both pre- and post intervention period, we measured a drastic 14h-reduction of the time to administration of the optimal antimicrobial treatment with the use of the molecular approach.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Target follow-up
- 1 Day
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- adult intensive care unit patients with positive blood cultures
Key inclusion criteria (1 listed)
- adult intensive care unit patients with positive blood cultures
Key exclusion criteria (1 listed)
- palliative care patients
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 blood culture identification panelFilmArray blood culture identification panel is performed 24 hours on 24hours and 7 days a week on positive blood cultures to accelerate pathogens detection | Diagnostic test | – |
Primary outcome
Turn Around Time to optimal treatment of septicemia
Time frame: From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours)
Time in minutes
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 9 May 2019.
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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?
An observational study of Septicemia, 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 1 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: finished, as of the sponsor's last update on 9 May 2019. 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 to optimal treatment of septicemia (time frame: From positivity detection of positive blood culture to administration of optimal treatment (up to 48 hours)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 May 2019; AzTrials last refreshed its copy on 8 Nov 2026.