Molecular Biomarkers for Sepsis

May 7, 2024 updated by: University Hospital, Basel, Switzerland

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Clinical Bacteriology and Mycology, University Hospital Basel
      • Basel, Switzerland, 4031
        • Infectious Diseases and Hospital Epidemiology, University Hospital Basel
      • Basel, Switzerland, 4031
        • Intensive Care Unit; University Hospital Basel
      • Bern, Switzerland, 3001
        • Institute for Infectious Diseases, University of Bern
      • Bern, Switzerland, 3010
        • Infectious Diseases and Hospital Epidemiology, University Hospital Bern
      • Bern, Switzerland, 3010
        • Intensive Care Unit, University Hospital Bern
      • Geneva, Switzerland, 1205
        • Clinical Bacteriology, University Hospital Geneva
      • Geneva, Switzerland, 1205
        • Intensive Care Unit, University Hospital Geneva
      • Geneva,, Switzerland, 1205
        • Infectious Diseases and Hospital Epidemiology, University Hospital Geneva
      • Lausanne, Switzerland, 1011
        • Clinical Microbiology, University Hospital Lausanne
      • Lausanne, Switzerland, 1011
        • Infectious Diseases and Hospital Epidemiology , University Hospital Lausanne
      • Lausanne, Switzerland, 1011
        • Intensive Care Unit, University Hospital Lausanne
      • Zürich, Switzerland, 8091
        • Infectious Diseases and Hospital Epidemiology, University Hospital Zurich
      • Zürich, Switzerland, 8091
        • Institute for Medical Microbiology, University Hospital Zurich
      • Zürich, Switzerland, 8091
        • Intensive Care Unit, University Hospital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Probability Sample

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.

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
patients with severe community acquired pneumonia (cases)
Cases: Patients with severe community acquired pneumonia with required ICU admission.
Other: compare data patterns by data-driven algorithms to determine sepsis
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to 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.
Other: compare data patterns by data-driven algorithms to determine sepsis
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to reliably determine sepsis
Other: compare data patterns by data-driven algorithms to predict sepsis-related mortality
compare data patterns by data-driven algorithms including machine learning and multi-dimensional modelling to to predict sepsis-related mortality

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
within 7 days after study inclusion
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)
within 7 days after study inclusion
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
within 7 days after study inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Hospital, Basel, Switzerland

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Swiss Personalized Health Network (SPHN)
Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Adrian Egli, PD Dr., Clinical Microbiology, University Hospital Basel

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 16, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 31, 2022

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 19, 2020

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 21, 2020

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 9, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 7, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2020-00297;qu18Egli3

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings