Molecular Biomarkers for Sepsis

March 28, 2022 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

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

400

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 Backup

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Recruiting
        • Infectious Diseases and Hospital Epidemiology, University Hospital Basel
        • Contact:
      • Basel, Switzerland, 4031
        • Recruiting
        • Clinical Bacteriology and Mycology, University Hospital Basel
        • Contact:
      • Basel, Switzerland, 4031
        • Recruiting
        • Intensive Care Unit; University Hospital Basel
        • Contact:
        • Contact:
      • Bern, Switzerland, 3001
        • Recruiting
        • Institute for Infectious Diseases, University of Bern
        • Contact:
      • Bern, Switzerland, 3010
        • Recruiting
        • Infectious Diseases and Hospital Epidemiology, University Hospital Bern
        • Contact:
      • Bern, Switzerland, 3010
        • Recruiting
        • Intensive Care Unit, University Hospital Bern
        • Contact:
      • Geneva, Switzerland, 1205
        • Recruiting
        • Clinical Bacteriology, University Hospital Geneva
        • Contact:
      • Geneva, Switzerland, 1205
        • Recruiting
        • Intensive Care Unit, University Hospital Geneva
        • Contact:
      • Geneva,, Switzerland, 1205
        • Recruiting
        • Infectious Diseases and Hospital Epidemiology, University Hospital Geneva
        • Contact:
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Clinical Microbiology, University Hospital Lausanne
        • Contact:
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Infectious Diseases and Hospital Epidemiology , University Hospital Lausanne
        • Contact:
      • Lausanne, Switzerland, 1011
        • Recruiting
        • Intensive Care Unit, University Hospital Lausanne
        • Contact:
          • Jean-Daniel Chiche, Prof. Dr. MD
      • Zürich, Switzerland, 8091
        • Recruiting
        • Infectious Diseases and Hospital Epidemiology, University Hospital Zurich
        • Contact:
      • Zürich, Switzerland, 8091
        • Recruiting
        • Institute for Medical Microbiology, University Hospital Zurich
        • Contact:
      • Zürich, Switzerland, 8091
        • Recruiting
        • Intensive Care Unit, University Hospital Zurich
        • Contact:

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

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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
Intervention / Treatment
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

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

University Hospital, Basel, Switzerland

Collaborators

Swiss Personalized Health Network (SPHN)
Personalized Health and Related Technologies (PHRT) initiative of ETH Zürich

Investigators

  • 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 (Anticipated)

April 1, 2022

Primary Completion (Anticipated)

October 1, 2023

Study Completion (Anticipated)

October 1, 2023

Study Registration Dates

First Submitted

February 19, 2020

First Submitted That Met QC Criteria

February 19, 2020

First Posted (Actual)

February 21, 2020

Study Record Updates

Last Update Posted (Actual)

April 7, 2022

Last Update Submitted That Met QC Criteria

March 28, 2022

Last Verified

March 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID 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.

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