SepsisNCT03474809
Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial.Pancreatic Stone Protein (PSP) Measured Using the AbioScope.
An observational study of Sepsis, run by Abionic SA at 14 sites in 4 countries.
Trial summary
The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis
- What is being tested?
- Blood sampling
- Type of treatment
- Medical device
- How many people
- 296 participants
- Where
- 14 sitesin 4 countries
- Study dates
- 14 Jun 2018to 15 Mar 2019
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Critically ill patients at high risk of sepsis admitted to the ICU.
Who may be able to join
- Adult patients (age ≥ 18 years)
- Requiring ICU management
- At high risk of sepsis (septic patients are excluded)
- Expected ICU stay for more than 4 days
- Have provided written informed consent or consent is given by the patient's legally designated representative.
Who cannot join
- Patient expected to die within 48 hours of admission to ICU
- Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy, but if a patient develops any pancreatic disease during the IUC stay he/she will remain in the study.
Trial locations and contacts
14 sites in 4 countries.
14 sites in 4 countries
France4 sites
CH Le Mans, Service de Réanimation Médico Chirurgicale & USC
Le Mans, 72037
CHU Limoges, Réanimation Polyvalente
Limoges, 87042
CH Lyon-Sud, Services de soins critiques
Pierre-Bénite, 69495
Hôpital Bretonneau, CHU de Tours, Médecine Intensive - Réanimation
Tours, 37044
Italy4 sites
Ospedale Santa Maria della Misericordia, Terapia Intensiva
Perugia, 6156
Ospedale Santa Maria delle Croci, Terapia Intensiva
Ravenna, 48121
Ospedale Infermi, Dept Anesthesia and ICU
Rimini, 47921
Ospedale San Giovanni Bosco, Servizio Anestesia e Rianimazione
Torino, 10154
Switzerland3 sites
Bern University Hospital, Universitätsklinik für Intensivmedizin
Bern, 3010
Hopitaux Universitaires de Genève, Service des soins intensifs, Département APSI
Geneva, 1205
Centre Hospitalier Universitaire Vaudois, Service of Adult Intensive Care
Lausanne, 1011
United Kingdom3 sites
Royal Surrey County Hospital, Intensive Care Medicine
Guildford, GU2 7XX
University College London Hospitals, Anaesthetics Department
London, NW1 2BU
Guy's & St Thomas' Hospital, Department of Critical Care
London, SE1 7EH
About this study
Official title: A Multicenter, Device Clinical Study for the Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial Pancreatic Stone Protein (PSP) Measured Using the AbioScope in Critically Ill Patients at High Risk of Sepsis.
The main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.
This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
- Conditions
- Sepsis
- Being tested
- Blood sampling
- Keywords
- Sepsis, PSP, Abionic
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingDevice
Daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of the performance of serial PSP values measured using the AbioScope.
- To assess the performance of serial PSP values measured using the AbioScope in the early detection of sepsis in ICU patients at high risk of developing sepsis.
Measured: Day 1 to Day 30, or until discharge from ICU
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2018
- Study start14 Jun 2018
- Primary completion15 Mar 2019
- Study completion15 Mar 2019
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 SepsisStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 296 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abionic SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474809
- Sponsor's protocol ID
- AB-PSP-001
- Status last verified
- Aug 2019
- First submitted
- 16 Mar 2018
- Last updated
- 13 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Pugin J, Daix T, Pagani JL, Morri D, Giacomucci A, Dequin PF, Guitton C, Que YA, Zani G, Brealey D, Lepape A, Creagh-Brown B, Wyncoll D, Silengo D, Irincheeva I, Girard L, Rebeaud F, Maerki I, Eggimann P, Francois B. Serial measurement of pancreatic stone protein for the early detection of sepsis in intensive care unit patients: a prospective multicentric study. Crit Care. 2021 Apr 20;25(1):151. doi: 10.1186/s13054-021-03576-8.
PubMed 33879189
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Device Clinical Study for the Early Diagnostic of Sepsis and Potential Impact on Antibiotic Management Based on Serial Pancreatic Stone Protein (PSP) Measured Using the AbioScope in Critically Ill Patients at High Risk of Sepsis.
- ClinicalTrials.gov ID
- NCT03474809
- Acronym / sponsor ID
- AB-PSP-001
- Conditions
- Sepsis
- Keywords
- Sepsis, PSP, Abionic
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 296 participants (actual)
- Lead sponsor
- Abionic SAIndustry (pharma, biotech, devices)
- Study start
- 14 Jun 2018 (actual)
- Primary completion
- 15 Mar 2019 (actual)
- Study completion
- 15 Mar 2019 (actual)
- First posted
- 23 Mar 2018 (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 main purpose of this study is to compare the early detection of sepsis and the decision, by the Investigator to start or not, or to change, antibiotics in Intensive Care Unit (ICU) patients at high risk of sepsis, based on standard of care (clinical, laboratory and imaging data but not on PSP values), as well as timing of antibiotic de-escalation versus the the retrospective assessment (i.e., at the end of the study) of a First Endpoint Adjudication Committee (EAC) which is aware of the clinical data and of the PSP values but not of the Investigator's decision(s), and of the retrospective assessment of a Second Endpoint Adjudication Committee which is only aware of the PSP values.
This study will follow the site's routine clinical practice for the diagnostic, assessment and treatment of the enrolled patients, with the exception of daily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]).
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Critically ill patients at high risk of sepsis admitted to the ICU.
Key inclusion criteria (5 listed)
- Adult patients (age ≥ 18 years)
- Requiring ICU management
- At high risk of sepsis (septic patients are excluded)
- Expected ICU stay for more than 4 days
- Have provided written informed consent or consent is given by the patient's legally designated representative.
Key exclusion criteria (2 listed)
- Patient expected to die within 48 hours of admission to ICU
- Patient suffering from or known acute or chronic pancreatitis, pancreatic cancer or admitted after pancreatectomy, but if a patient develops any pancreatic disease during the IUC stay he/she will remain in the study.
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 |
|---|---|---|
| Blood samplingDaily blood samples which will be taken for the PSP measurement using the AbioScope as well as another daily sample taken for central analysis of biomarkers of inflammation, infection and/or sepsis (including but not limited to C-reactive protein [CRP] and Procalcitonin [PCT]). | Device | – |
Primary outcome
Assessment of the performance of serial PSP values measured using the AbioScope.
Time frame: Day 1 to Day 30, or until discharge from ICU
i) To assess the performance of serial PSP values measured using the AbioScope in the early detection of sepsis in ICU patients at high risk of developing sepsis.
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 13 Aug 2019.
- Derived from this study: PubMed 33879189Pugin J, Daix T, Pagani JL, Morri D, Giacomucci A, Dequin PF, Guitton C, Que YA, Zani G, Brealey D, Lepape A, Creagh-Brown B, Wyncoll D, Silengo D, Irincheeva I, Girard L, Rebeaud F, Maerki I, Eggimann P, Francois B. Serial measurement of pancreatic stone protein for the early detection of sepsis in intensive care unit patients: a prospective multicentric study. Crit Care. 2021 Apr 20;25(1):151. doi: 10.1186/s13054-021-03576-8.
- Individual participant dataSharing planned: Undecided
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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.
14 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis, run by Abionic SA at 14 sites in 4 countries.
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 5 inclusion and 2 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 13 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France, Italy, Switzerland, United Kingdom. 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?
Assessment of the performance of serial PSP values measured using the AbioScope. (time frame: Day 1 to Day 30, or until discharge from ICU). 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 NCT03474809, 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 13 Aug 2019.