SepsisSABERNCT02424721
Sepsis Assessment in Belgian Emergency Rooms
An observational study of Sepsis and Shock, Septic, run by Axis Shield Diagnostics Ltd at 4 sites in Belgium.
Trial summary
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Shock, Septic, Severe Sepsis
- How many people
- 100 participants
- Where
- 4 sitesBelgium
- Study dates
- May 2015to Dec 2018
- 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: Patients presenting to the Emergency Department with suspected infection
Who may be able to join
- >18 years of age,
- Suspected infection (temperature >38C or clinical evidence of infection),
- intention by clinician to start antibiotics
Who cannot join
- None
Trial locations and contacts
4 sites in 1 country.
Belgium4 sites
Clinique St Anne St Remy
Anderlecht, 1070
Hopital Erasme
Brussels, 1070
Hopital Civil de Charleroi
Charleroi, 6000
CHU Tivoli
La Louvière, 7100
About this study
Official title: Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.
Read the detailed description
Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission.
Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken.
The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.
- Conditions
- Sepsis, Shock, Septic, Severe Sepsis
- Medical subject headings
- Sepsis, Shock, Septic
What is being measured
The primary outcome is the main question the study is designed to answer.
Validation of use of HBP in evaluation of patients with suspected infection
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2015 (estimated)
- Study startMay 2015
- Primary completionDec 2018
- Study completionDec 2018
Why it stopped: Resource constraints at participating sites
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Axis Shield Diagnostics Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jean-Louis Vincent, MD, Principal investigator, Erasme University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02424721
- Sponsor's protocol ID
- PEP-FMHBP-003
- Acronym
- SABER
- Status last verified
- Jan 2019
- First submitted
- 15 Apr 2015
- Last updated
- 9 Jan 2019
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Non-interventional, Multi-centre Clinical Study to Assess the Clinical Validity of the Heparin Binding Protein Assay to Assist in Evaluation of Patients With Suspected Infection Following Emergency Department Admission
- ClinicalTrials.gov ID
- NCT02424721
- Acronym / sponsor ID
- SABER / PEP-FMHBP-003
- Conditions
- Sepsis, Shock, Septic, Severe Sepsis
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Resource constraints at participating sites
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Axis Shield Diagnostics LtdIndustry (pharma, biotech, devices)
- Study start
- May 2015
- Primary completion
- Dec 2018 (actual)
- Study completion
- Dec 2018 (actual)
- First posted
- 23 Apr 2015 (estimated)
- 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.
To validate the use of the Heparin Binding Protein (HBP) concentration to assist in the evaluation of patients admitting to the emergency department with suspected infection.
Detailed description
Prospective, non-interventional, multi-centre clinical study to assess the clinical validity of the Heparin Binding Protein (HBP) assay to assist in evaluation of patients with suspected infection following emergency department admission.
Patients presenting to the emergency department with suspected infection will be enrolled to the study and have a blood sample taken.
The patients clinical data over a 72 hour period after enrolment will be recorded in the CRF. The enrolment sample will then be retrospectively measured for the HBP level and the power of the enrolment HBP level to predict subsequent clinical development over the following 72 hours will be assessed. Data analysis shall include Area Under Curve (AUC) from Receiver Operating Characteristics (ROC) plot against the patient's final clinical diagnosis as well as sensitivity and specificity of the HBP level to predict the final clinical outcome.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients presenting to the Emergency Department with suspected infection
Key inclusion criteria (3 listed)
- >18 years of age,
- Suspected infection (temperature >38C or clinical evidence of infection),
- intention by clinician to start antibiotics
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.
Primary outcome
Validation of use of HBP in evaluation of patients with suspected infection
Time frame: 12 months
Results and safety
The study was stopped early (reason given: Resource constraints at participating sites). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 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.
Jean-Louis Vincent, MD principal investigator
Erasme University Hospital
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Sepsis and Shock, Septic, run by Axis Shield Diagnostics Ltd at 4 sites 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 3 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: stopped early, as of the sponsor's last update on 9 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites 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 was stopped early (reason given: Resource constraints at participating sites). 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?
Validation of use of HBP in evaluation of patients with suspected infection (time frame: 12 months). 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 Jan 2019.