SepsisNCT04280354
Molecular Biomarkers for Sepsis
An observational study of Sepsis and Severe Community-acquired Pneumonia (sCAP), run by University Hospital, Basel, Switzerland at 15 sites in Switzerland.
Trial summary
This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Severe Community-acquired Pneumonia (sCAP), Infection, Bacterial
- What is being tested?
- compare data patterns by data-driven algorithms to determine sepsis and compare data patterns by data-driven algorithms to predict sepsis-related mortality
- How many people
- 3 participants
- Where
- 15 sitesSwitzerland
- Study dates
- 16 Feb 2022to 31 Jul 2022
- 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: Adult patients fulfilling the WHO-definition of a severe community acquired pneumonia (sCAP, cases) and patients with an inflammatory phenotype (controls) requiring intensive care medicine.
Who may be able to join
- Admission to the ICU of one of the participating centers.
- Cases: severe community acquired pneumonia with requirement for ICU admission.
- Controls: Clinical phenotype of inflammation not due to suspected sepsis In addition, control patients will be patients with fever >38°C, CRP >100mg/L, no infection focus expected in ≥ 24h.
- All required sample types can most likely be collected within the first 24h visits.
- Expected ICU stay of more than 24h.
Who cannot join
- Admission to the hospital within the prior 14 days.
- Patients with psychosis
- Evidence of a hospital acquired pneumonia.
- One of the following respiratory conditions: Acute exacerbation of chronic obstructive pulmonary disease (COPD) or bronchiectasis, acute severe asthma, aspiration pneumonia, tuberculosis, clinical suspected viral pneumonia without bacterial infection, cardiogenic pulmonary oedema.
- Patients with an acute respiratory distress Syndrome (ARDS).
- Patient which can be managed as outpatients and do not require an ICU.
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- Patient where a transmission to another institution is likely within the next 24h.
- Documented rejection of the general consent or participation to research in general.
- Patients with a palliative situation and a life expectancy due to other diseases (e.g. progressed cancer) less than 28 days.
Trial locations and contacts
15 sites in 1 country.
15 sites in 1 country
Switzerland15 sites
Clinical Bacteriology and Mycology, University Hospital Basel
Basel, 4031
Infectious Diseases and Hospital Epidemiology, University Hospital Basel
Basel, 4031
Intensive Care Unit; University Hospital Basel
Basel, 4031
Institute for Infectious Diseases, University of Bern
Bern, 3001
Infectious Diseases and Hospital Epidemiology, University Hospital Bern
Bern, 3010
Intensive Care Unit, University Hospital Bern
Bern, 3010
Clinical Bacteriology, University Hospital Geneva
Geneva, 1205
Infectious Diseases and Hospital Epidemiology, University Hospital Geneva
Geneva, 1205
Intensive Care Unit, University Hospital Geneva
Geneva, 1205
Clinical Microbiology, University Hospital Lausanne
Lausanne, 1011
Infectious Diseases and Hospital Epidemiology , University Hospital Lausanne
Lausanne, 1011
Intensive Care Unit, University Hospital Lausanne
Lausanne, 1011
Infectious Diseases and Hospital Epidemiology, University Hospital Zurich
Zurich, 8091
Institute for Medical Microbiology, University Hospital Zurich
Zurich, 8091
Intensive Care Unit, University Hospital Zurich
Zurich, 8091
About this study
Official title: Prospective Study to Discover New Biomarkers for Early Detection of Sepsis and Prediction of Sepsis-related Mortality in Patients With Severe Community Acquired Pneumonia (sCAP)
This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Patients with sCAP (cases) will be profoundly characterized over time regarding the development of sepsis and compared with control patients. The mechanisms and influencing factors on the clinical course will be explored with most modern -omics technologies allowing a detailed characterisation. These data will be analysed using machine learning algorithms and multi-dimensional mathematical models.
- Being tested
- compare data patterns by data-driven algorithms to determine sepsis, compare data patterns by data-driven algorithms to predict sepsis-related mortality
- Keywords
- Community-acquired Pneumonia, biomarker, clinical data warehouse (CDWH), machine learning, data-driven algorithms, multi-dimensional modelling, sepsis-related mortality, Streptococcus pneumoniae
- Medical subject headings
- Sepsis, Community-Acquired Pneumonia, Bacterial Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
compare data patterns by data-driven algorithms to determine sepsisOther
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
compare data patterns by data-driven algorithms to predict sepsis-related mortalityOther
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality
| Study group | Role | What they receive |
|---|---|---|
| patients with severe community acquired pneumonia (cases) | Cases: Patients with severe community acquired pneumonia with required ICU admission. Receives: Other: compare data patterns by data-driven algorithms to determine sepsis; Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality | |
| patients without pneumonia or sepsis (controls) | Controls: Clinical phenotype of inflammation not due to suspected sepsis; patients with fever >38°C, C reactive Protein (CRP) >100mg/L, no infection focus expected in ≥ 24h. Receives: Other: compare data patterns by data-driven algorithms to determine sepsis; Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality |
What is being measured
The primary outcome is the main question the study is designed to answer.
Detection of sepsis
Sepsis detection based on new discovered digital biomarkers will be compared to classical sepsis-3 criteria (with an increase of the sequential organ failure assessment (SOFA) score of 2 or larger score points).
Measured: within 7 days after study inclusion
Sepsis related mortality
Prediction of sepsis related mortality (with >80% sensitivity and specificity at least 24h prior to event)
Measured: within 7 days after study inclusion
Time to sepsis detection (minutes after Intensive Care Unit (ICU) admission)
Time to sepsis detection (minutes after ICU admission) based on machine learning
Measured: within 7 days after study inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2020
- Study start16 Feb 2022
- Primary completion31 Jul 2022
- Study completion31 Jul 2022
Why it stopped: Recruitment failure
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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Basel, Switzerland
- Sponsor type
- University, hospital or other
- Collaborators
- Swiss Personalized Health Network (SPHN), Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich
- Responsible party
- Sponsor
- Investigators
- Adrian Egli, PD Dr., Principal investigator, Clinical Microbiology, University Hospital Basel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04280354
- Sponsor's protocol ID
- 2020-00297;qu18Egli3
- Status last verified
- May 2024
- First submitted
- 19 Feb 2020
- Last updated
- 9 May 2024
- 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 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Study to Discover New Biomarkers for Early Detection of Sepsis and Prediction of Sepsis-related Mortality in Patients With Severe Community Acquired Pneumonia (sCAP)
- ClinicalTrials.gov ID
- NCT04280354
- Acronym / sponsor ID
- 2020-00297;qu18Egli3
- Keywords
- Community-acquired Pneumonia, biomarker, clinical data warehouse (CDWH), machine learning, data-driven algorithms, multi-dimensional modelling, sepsis-related mortality, Streptococcus pneumoniae
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Recruitment failure
- Enrolment
- 3 participants (actual)
- Lead sponsor
- University Hospital, Basel, SwitzerlandUniversity, hospital or other
- Collaborators
- Swiss Personalized Health Network (SPHN), Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich
- Study start
- 16 Feb 2022 (actual)
- Primary completion
- 31 Jul 2022 (actual)
- Study completion
- 31 Jul 2022 (actual)
- First posted
- 21 Feb 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.
This multi-center observational case-control study in Intensive Care Unit (ICU) patients is to identify novel biomarkers allowing to recognize severe community acquired pneumonia (sCAP) -associated sepsis at an earlier stage and predict sepsis-related mortality. Patients with sCAP (cases) will be profoundly characterized over time regarding the development of sepsis and compared with control patients. The mechanisms and influencing factors on the clinical course will be explored with most modern -omics technologies allowing a detailed characterisation. These data will be analysed using machine learning algorithms and multi-dimensional mathematical models.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with severe community acquired pneumonia (cases) | – | Other: compare data patterns by data-driven algorithms to determine sepsis, Other: compare data patterns by data-driven algorithms to predict sepsis-related mortalityCases: Patients with severe community acquired pneumonia with required ICU admission. |
| patients without pneumonia or sepsis (controls) | – | Other: compare data patterns by data-driven algorithms to determine sepsis, Other: compare data patterns by data-driven algorithms to predict sepsis-related mortalityControls: Clinical phenotype of inflammation not due to suspected sepsis; patients with fever >38°C, C reactive Protein (CRP) >100mg/L, no infection focus expected in ≥ 24h. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients fulfilling the WHO-definition of a severe community acquired pneumonia (sCAP, cases) and patients with an inflammatory phenotype (controls) requiring intensive care medicine.
Key inclusion criteria (5 listed)
- Admission to the ICU of one of the participating centers.
- Cases: severe community acquired pneumonia with requirement for ICU admission.
- Controls: Clinical phenotype of inflammation not due to suspected sepsis In addition, control patients will be patients with fever >38°C, CRP >100mg/L, no infection focus expected in ≥ 24h.
- All required sample types can most likely be collected within the first 24h visits.
- Expected ICU stay of more than 24h.
Key exclusion criteria (9 listed)
- Admission to the hospital within the prior 14 days.
- Patients with psychosis
- Evidence of a hospital acquired pneumonia.
- One of the following respiratory conditions: Acute exacerbation of chronic obstructive pulmonary disease (COPD) or bronchiectasis, acute severe asthma, aspiration pneumonia, tuberculosis, clinical suspected viral pneumonia without bacterial infection, cardiogenic pulmonary oedema.
- Patients with an acute respiratory distress Syndrome (ARDS).
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 |
|---|---|---|
| compare data patterns by data-driven algorithms to determine sepsiscompare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis | Other | patients with severe community acquired pneumonia (cases), patients without pneumonia or sepsis (controls) |
| compare data patterns by data-driven algorithms to predict sepsis-related mortalitycompare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality | Other | patients with severe community acquired pneumonia (cases), patients without pneumonia or sepsis (controls) |
Primary outcome
Detection of sepsis
Time frame: within 7 days after study inclusion
Sepsis detection based on new discovered digital biomarkers will be compared to classical sepsis-3 criteria (with an increase of the sequential organ failure assessment (SOFA) score of 2 or larger score points).
Sepsis related mortality
Time frame: within 7 days after study inclusion
Prediction of sepsis related mortality (with >80% sensitivity and specificity at least 24h prior to event)
Time to sepsis detection (minutes after Intensive Care Unit (ICU) admission)
Time frame: within 7 days after study inclusion
Time to sepsis detection (minutes after ICU admission) based on machine learning
Results and safety
The study was stopped early (reason given: Recruitment failure). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 May 2024.
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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.
Adrian Egli, PD Dr. principal investigator
Clinical Microbiology, University Hospital Basel
15 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 Severe Community-acquired Pneumonia (sCAP), run by University Hospital, Basel, Switzerland at 15 sites in Switzerland.
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 9 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 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in Switzerland. 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: Recruitment failure). 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?
Detection of sepsis (time frame: within 7 days after study inclusion). The study lists 3 primary outcomes in all. 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 2024.